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Visugromab Plus Nivolumab Shows Promise in Anti-PD-1 Refractory Solid Tumors by Targeting GDF-15 Pathway

Monoclonal Antibody
  • Visugromab (CTL-002), a GDF-15 neutralizing antibody, combined with nivolumab demonstrated initial efficacy in the phase 2A GDFATHER-TRIAL for patients with advanced solid tumors that had relapsed or were refractory to prior anti-PD-1/PD-L1 therapy.
  • GDF-15 plays a critical role in tumoral immunosuppression by blocking immune cell entry into the tumor microenvironment and interfering with immune synapse formation, which many tumors exploit to resist immunotherapy.
  • The combination therapy represents a novel approach to overcome immunotherapy resistance by neutralizing GDF-15's immunosuppressive effects and potentially restoring T-cell function in the tumor microenvironment.
  • This therapeutic strategy addresses a significant unmet medical need for patients whose cancers have progressed on checkpoint inhibitor therapy, offering a potential pathway to re-sensitize tumors to immune-based treatments.

Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400 as Monotherapy and in Combination With IV Bevacizumab

NCT05029882Active, Not RecruitingPhase 1
AbbVie
Posted 10/13/2021

SKB264 Combinatiton Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer.

NCT05351788RecruitingPhase 2
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Posted 5/20/2022

SKB264 Monotherapy in Selected Subjects with Advanced Solid Tumors

NCT05631262Active, Not RecruitingPhase 2
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Posted 11/30/2022

Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)

NCT06393374RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 6/24/2024

Study of Ibrutinib + CD20 Antibody and Venetoclax in Patients With Untreated Mantle Cell Lymphoma

NCT04802590RecruitingPhase 2
The Lymphoma Academic Research Organisation
Posted 1/24/2022

Safety and Efficacy of ALLO-316 in Subjects With Advanced or Metastatic Clear Cell Renal Cell Carcinoma

NCT04696731Active, Not RecruitingPhase 1
Allogene Therapeutics
Posted 2/24/2021

A Multiple Dose Study to Evaluate Safety, Tolerability, PK, and Efficacy of SER-155 in Adults Undergoing HSCT

NCT04995653CompletedPhase 1
Seres Therapeutics, Inc.
Posted 11/24/2021

Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia

NCT05384587Active, Not RecruitingPhase 2
Novartis Pharmaceuticals
Posted 11/11/2022

Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort

NCT05693766RecruitingPhase 2
Sonya Reid
Posted 9/11/2023

Phase I Study of HSK42360 in Solid Tumors With BRAF V600 Mutation

NCT06536400RecruitingPhase 1
Haisco Pharmaceutical Group Co., Ltd.
Posted 6/25/2024

An Open-label, Multicenter Study of ZL-1310 in Subjects With Small Cell Lung Cancer

NCT06179069RecruitingPhase 1
Zai Lab (Shanghai) Co., Ltd.
Posted 1/23/2024

HLX301 (TIGIT×PDL1 Bispecific) in Patients With Locally Advanced or Metastatic Solid Tumors

NCT05102214RecruitingPhase 1
Shanghai Henlius Biotech
Posted 5/3/2022

Transarterial Chemoembolization for the Treatment of Uveal Melanoma With Liver Metastases

NCT04728633Active, Not RecruitingPhase 2
Thomas Jefferson University
Posted 9/27/2021

A Phase 1 Study of BRG01 in Subjects With Relapsed/Metastatic Epstein-Barr Virus (EBV)-Positive Nasopharyngeal Carcinoma

NCT05864924CompletedPhase 1
BioSyngen Pte Ltd
Posted 5/10/2023

SKB264 +/- KL-A167 in Recurrent or Metastatic HER2-negative Breast Cancer

NCT05445908RecruitingPhase 2
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Posted 8/17/2022

The Safety and Efficacy of RD06-03 CART Cell Injection in Patients With R/R Acute B-lymphoblastic Leukemia

NCT06307600RecruitingEarly Phase 1
Anhui Provincial Hospital
Posted 3/15/2024

Study of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors

NCT05969041RecruitingPhase 1
Myeloid Therapeutics
Posted 8/2/2023

Study of Orally Administered AG-120 in Subjects With Advanced Solid Tumors, Including Glioma, With an IDH1 Mutation

NCT02073994CompletedPhase 1
Institut de Recherches Internationales Servier
Posted 3/1/2014

A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer

NCT04607421Active, Not RecruitingPhase 3
Pfizer
Posted 12/21/2020

SKB264 Injection Vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer

NCT05347134Active, Not RecruitingPhase 3
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Posted 6/10/2022

Safety, Tolerability and Preliminary Efficacy of IBI363 in Subjects With Advanced Solid Tumors or Lymphoma

NCT05460767RecruitingPhase 1
Innovent Biologics (Suzhou) Co. Ltd.
Posted 8/31/2022

Newly Diagnosed Glioblastoma

NCT04959500Unknown StatusPhase 2
Sun Yat-sen University
Posted 6/10/2021

A Study of AZD0486 in Subjects With B-Cell Non-Hodgkin Lymphoma

NCT04594642RecruitingPhase 1
AstraZeneca
Posted 3/2/2021

Pilot Study of Anlotinib With STUPP Regimen for Patients With Newly Diagnosed Glioblastoma

NCT04119674CompletedPhase 1
Zhejiang Cancer Hospital
Posted 3/19/2019

A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer

NCT04505826CompletedPhase 1
Olema Pharmaceuticals, Inc.
Posted 8/13/2020

A Phase II Study of SSGJ-707 Monotherapy in First-line PD-L1 Positive Advanced NSCLC Patients

NCT06361927RecruitingPhase 2
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Posted 5/15/2024

Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma

NCT03145181Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 5/16/2017

A Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer

NCT04898634Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 7/13/2021

CTS2190 Phase I /II Clinical Study in Patients

NCT06224387RecruitingPhase 1
CytosinLab Therapeutics Co., Ltd.
Posted 6/26/2023

Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma

NCT04484623Active, Not RecruitingPhase 3
GlaxoSmithKline
Posted 10/1/2020

A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL

NCT03336333Active, Not RecruitingPhase 3
BeiGene
Posted 10/31/2017

A 1/2 Phase Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ASKB589 in Patients With Locally Advanced or Metastatic Solid Tumors

NCT04632108Active, Not RecruitingPhase 1
Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Posted 1/28/2021

PRediction Of Five Usual Tumors Using Blood Test for Risk Assessment and Early Detection

NCT05874648Not Yet Recruiting
Sixth Affiliated Hospital, Sun Yat-sen University
Posted 7/7/2023

Fulvestrant and Ipatasertib for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor

NCT04650581Active, Not RecruitingPhase 3
Canadian Cancer Trials Group
Posted 1/27/2021

A Study to Test BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) and BI 765179 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Cancer

NCT04958239RecruitingPhase 1
Boehringer Ingelheim
Posted 10/18/2021

RC108 Combine With Furmonertinib With/Without Toripalimab in Patients With EGFR-mutated NSCLC

NCT05821933RecruitingPhase 1
RemeGen Co., Ltd.
Posted 9/7/2023

A Phase I/II Study to Evaluate AZD5851 in GPC3+ Advanced/Recurrent Hepatocellular Carcinoma

NCT06084884Active, Not RecruitingPhase 1
AstraZeneca
Posted 12/14/2023

Safety and Efficacy of Reduced-port Laparoscopic Surgery for Patients Of Colon and Upper Rectal Cancer

NCT05953662Active, Not RecruitingNot Applicable
Sixth Affiliated Hospital, Sun Yat-sen University
Posted 9/1/2023

ARTEMIS-001: Phase 1 Study of the HS-20093 in Patients With Advanced Solid Tumors

NCT05276609RecruitingPhase 1
Shanghai Hansoh Biomedical Co., Ltd
Posted 11/28/2021

ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study

NCT04620239RecruitingPhase 3
Steba Biotech S.A.
Posted 3/22/2021

A Study of IBI363 in Subjects With Advanced Melanoma

NCT06081920RecruitingPhase 2
Innovent Biologics (Suzhou) Co. Ltd.
Posted 10/19/2023

Study of ICP-723 in Patients With Advanced Solid Tumors or Primary Central Nervous System Tumors

NCT05745623RecruitingPhase 1
Beijing InnoCare Pharma Tech Co., Ltd.
Posted 12/27/2022

Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer

NCT03539536Active, Not RecruitingPhase 2
AbbVie
Posted 10/10/2018

Treatment of Tumors in the Urinary Collecting System of the Kidney or Ureter Using a Light Activated Drug (WST11)

NCT03617003CompletedPhase 1
Memorial Sloan Kettering Cancer Center
Posted 8/1/2018

Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)

NCT04728893RecruitingPhase 2
Merck Sharp & Dohme LLC
Posted 4/5/2021

A Study of KL590586 in Patients With Advanced Solid Tumors

NCT05265091Active, Not RecruitingPhase 1
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Posted 6/1/2021

Sequential Combo Immuno and Target Therapy (SECOMBIT) Study

NCT02631447CompletedPhase 2
Fondazione Melanoma Onlus
Posted 11/14/2016

A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers

NCT03400332Active, Not RecruitingPhase 1
Bristol-Myers Squibb
Posted 2/12/2018

Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC

NCT04140526Active, Not RecruitingPhase 1
OncoC4, Inc.
Posted 9/16/2020

A Phase I/II Clinical Trial of ICP-723 in the Treatment of Advanced Solid Tumors

NCT04685226RecruitingPhase 1
Beijing InnoCare Pharma Tech Co., Ltd.
Posted 9/27/2020

Chemotherapy and Maximal Tumor Debulking of Multi-organ Colorectal Cancer Metastases

NCT01792934Active, Not RecruitingNot Applicable
Radboud University Medical Center
Posted 5/1/2013

A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT04557098Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 9/17/2020

FDA Approves Tevimbra-Chemotherapy Combination for First-Line Treatment of Advanced Esophageal Squamous Cell Carcinoma

Monoclonal AntibodyOncologyFDA Approval
  • The FDA has approved BeiGene's Tevimbra (tislelizumab-jsgr) in combination with platinum-containing chemotherapy for first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1.
  • In the pivotal RATIONALE-306 trial, patients treated with Tevimbra plus chemotherapy demonstrated a median overall survival of 16.8 months compared to 9.6 months with chemotherapy alone, representing a 34% reduction in risk of death.
  • This marks BeiGene's third FDA approval in less than a year, following previous approvals for Tevimbra in second-line ESCC and first-line gastric/gastroesophageal junction cancers, highlighting the company's expanding oncology portfolio.

Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma

NCT03777657CompletedPhase 3
BeiGene
Posted 12/13/2018

A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

NCT03783442CompletedNot Applicable
BeiGene
Posted 12/11/2018

Tislelizumab Combined With Chemotherapy Versus Chemotherapy Alone in Recurrent or Metastatic Nasopharyngeal Cancer (NPC)

NCT03924986CompletedPhase 3
BeiGene
Posted 3/27/2019

Study of Platinum Plus Etoposide With or Without Tislelizumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer

NCT04005716CompletedPhase 3
BeiGene
Posted 7/22/2019

A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

NCT03430843CompletedPhase 3
BeiGene
Posted 1/26/2018

Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)

NCT04379635Active, Not RecruitingPhase 3
BeiGene
Posted 5/29/2020

Galderma's Phase III OLYMPIA 1 Trial Results Show Nemolizumab Significantly Improves Prurigo Nodularis Symptoms

Monoclonal AntibodyDrug Approval
• Newly published results in JAMA Dermatology demonstrate nemolizumab monotherapy significantly improved itch intensity and skin lesions in patients with moderate-to-severe prurigo nodularis compared to placebo.
• The OLYMPIA 1 trial showed rapid response as early as Week 4, with over six times more nemolizumab-treated patients achieving itch response and twenty times more reaching an itch-free or nearly itch-free state compared to placebo.
• Based on the OLYMPIA clinical trial program, nemolizumab (Nemluvio®) received FDA approval for adult prurigo nodularis in August 2024, with additional regulatory reviews ongoing worldwide.

A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

NCT04501679CompletedPhase 3
Galderma R&D
Posted 8/11/2020

Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

NCT04501666CompletedPhase 3
Galderma R&D
Posted 9/11/2020

Düsseldorf UPC Ruling Clarifies "Imminent Infringement" Standards for Biosimilars

Monoclonal Antibody
  • The Düsseldorf Local Division of the Unified Patent Court has issued a significant ruling that establishes clearer standards for determining "imminent infringement" in pharmaceutical patent cases.
  • In the Novartis/Genentech v. Celltrion case, the court ruled that obtaining marketing authorization and promoting a biosimilar at conferences are insufficient to constitute imminent infringement without completed pricing negotiations.
  • The decision provides important guidance for pharmaceutical companies, indicating that patent holders must demonstrate that all pre-launch preparations have been completed before claiming imminent infringement.

LEO Pharma's Temtokibart Shows Comparable Efficacy to Dupilumab in Phase 2a Atopic Dermatitis Trial

Monoclonal Antibody
  • LEO Pharma's investigational IL-22 inhibitor temtokibart demonstrated comparable clinical improvements to dupilumab in a 16-week phase 2a trial for moderate-to-severe atopic dermatitis.
  • Temtokibart achieved faster and greater improvements in skin hydration and natural moisturizing factors compared to dupilumab, with significant benefits observed within one week.
  • The findings suggest IL-22 pathway inhibition represents a novel therapeutic approach beyond Type 2 inflammation targeting for atopic dermatitis treatment.
  • LEO Pharma has completed recruitment for a phase 2b dose-finding trial with results expected in Q1 2025.

A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)

NCT05651711CompletedPhase 3
Amgen
Posted 12/14/2022

Study of ASLAN004 in Healthy Subjects

NCT03721263CompletedPhase 1
ASLAN Pharmaceuticals
Posted 10/15/2018

A Study of KY1005 in Healthy Volunteers

NCT03161288CompletedPhase 1
Kymab Limited
Posted 5/29/2017

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor

NCT06241118RecruitingPhase 3
Sanofi
Posted 2/29/2024

Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

NCT03989349CompletedPhase 3
Galderma R&D
Posted 6/30/2019

Phase 2b Study of ASLAN004 in Adults With Moderate-to-Severe Atopic Dermatitis

NCT05158023CompletedPhase 2
ASLAN Pharmaceuticals
Posted 3/16/2022

Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis

NCT03989206Active, Not RecruitingPhase 3
Galderma R&D
Posted 12/30/2019

A Study of CM310 in Subjects With Moderate-to-Severe Atopic Dermatitis

NCT06116565Not Yet RecruitingPhase 2
Keymed Biosciences Co.Ltd
Posted 3/30/2024

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids

NCT06224348Active, Not RecruitingPhase 3
Sanofi
Posted 1/18/2024

A Study to Evaluate the Safety and Efficacy of AK120 in Subjects With Moderate to Severe Atopic Dermatitis

NCT06092762CompletedPhase 2
Akeso
Posted 11/6/2023

A Study of KY1005 in Patients With Moderate to Severe Atopic Dermatitis

NCT03754309CompletedPhase 2
Kymab Limited
Posted 12/13/2018

A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AK120 in Subjects With Atopic Dermatitis

NCT06035354CompletedPhase 1
Akeso
Posted 11/3/2021

A Study to Evaluate the Safety and Efficacy of CBP-201 in Chinese Adult Subjects With Moderate to Severe AD

NCT05905133Active, Not RecruitingPhase 2
Suzhou Connect Biopharmaceuticals, Ltd.
Posted 7/15/2023

A Phase 2 Study of CIM331 for Atopic Dermatitis Patients

NCT01986933CompletedPhase 2
Chugai Pharmaceutical
Posted 11/1/2013

A Study to Investigate Vaccine Responses in Subcutaneous Amlitelimab Treated Atopic Dermatitis Participants Aged 18 Years and Older Compared With Placebo

NCT06015308Active, Not RecruitingPhase 2
Sanofi
Posted 10/6/2023

The Study of CM310 in Patients With Atopic Dermatitis

NCT04893707CompletedPhase 2
Keymed Biosciences Co.Ltd
Posted 6/7/2021

Study of CM310 in Adolescent Subjects With Atopic Dermatis

NCT06495229Active, Not RecruitingPhase 3
Keymed Biosciences Co.Ltd
Posted 8/2/2024

POC Study to Evaluate BSI-045B in Moderate-to-severe Atopic Dermatitis

NCT05932654CompletedPhase 2
Biosion, Inc.
Posted 7/31/2023

Study of CM310 Injection in Subjects With Moderate-to-Severe Atopic Dermatitis

NCT05715320CompletedPhase 2
Keymed Biosciences Co.Ltd
Posted 3/10/2023

A Study of CM310 in Patients With Moderate-to-Severe Atopic Dermatitis

NCT05265923CompletedPhase 3
Keymed Biosciences Co.Ltd
Posted 4/22/2022

A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)

NCT05398445CompletedPhase 3
Amgen
Posted 5/31/2022

A Study Assessing Rocatinlimab on Vaccine Antibody Response in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET - VOYAGER)

NCT05899816CompletedPhase 3
Amgen
Posted 6/7/2023

A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

NCT05704738Active, Not RecruitingPhase 3
Amgen
Posted 4/20/2023

Study of CM310 in Children Subjects With Moderate-to-severe Atopic Dermatis

NCT06162507CompletedPhase 1
Keymed Biosciences Co.Ltd
Posted 12/22/2023

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (COAST 2)

NCT06181435Active, Not RecruitingPhase 3
Sanofi
Posted 12/21/2023

A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

NCT05633355CompletedPhase 3
Amgen
Posted 1/30/2023

Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis

NCT04921345CompletedPhase 2
Galderma R&D
Posted 6/24/2021

Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study

NCT05131477CompletedPhase 2
Kymab Limited
Posted 12/13/2021

A Study to Assess the Efficacy and Safety of CBP-201 in Adult Subjects With Moderate to Severe Atopic Dermatitis

NCT04444752CompletedPhase 2
Suzhou Connect Biopharmaceuticals, Ltd.
Posted 7/17/2020

Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials

NCT05492578RecruitingPhase 2
Sanofi
Posted 8/22/2022

Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis

NCT05048056TerminatedPhase 2
Akesobio Australia Pty Ltd
Posted 9/30/2021

A Trial to Evaluate the Efficacy and Safety of Different Doses of LEO 138559 in Adults With Moderate-to-severe Atopic Dermatitis

NCT05923099CompletedPhase 2
LEO Pharma
Posted 9/20/2023

A Pharmacokinetics and Safety Study of Nemolizumab in Adolescent Participants With Atopic Dermatitis (AD)

NCT03921411CompletedPhase 2
Galderma R&D
Posted 4/9/2019

Dose-ranging Study of Nemolizumab in Atopic Dermatitis

NCT03100344CompletedPhase 2
Galderma R&D
Posted 6/14/2017

Study of Eblasakimab in Male or Female Moderate-to-Severe Atopic Dermatitis Patients Previously Treated With Dupilumab

NCT05694884RecruitingPhase 2
ASLAN Pharmaceuticals
Posted 12/21/2022

Study of CM310 Injection in Adolescent Subjects With Atopic Dermatis

NCT06277765CompletedPhase 3
Keymed Biosciences Co.Ltd
Posted 3/21/2024

A Study to Evaluate the Efficacy and Safety of CBP-201 in Moderate to Severe Atopic Dermatitis in China

NCT05017480CompletedPhase 2
Suzhou Connect Biopharmaceuticals, Ltd.
Posted 8/31/2021

A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

NCT05882877RecruitingPhase 3
Amgen
Posted 5/31/2023

Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

NCT03985943CompletedPhase 3
Galderma R&D
Posted 6/27/2019

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

NCT06130566Active, Not RecruitingPhase 3
Sanofi
Posted 11/8/2023

A Study With Self-administered Rocatinlimab in Adolescent and Adult Participants With Moderate-to-severe Atopic Dermatitis

NCT06224192Active, Not RecruitingPhase 3
Amgen
Posted 4/2/2024

A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis

NCT04090229CompletedPhase 1
ASLAN Pharmaceuticals
Posted 9/9/2019

A Phase III Study to Evaluate the Efficacy and Safety of AK120 in Patients With Moderate to Severe Atopic Dermatitis

NCT06383468RecruitingPhase 3
Akeso
Posted 4/30/2024

Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

NCT05769777RecruitingPhase 2
Sanofi
Posted 4/3/2023

A Study of CM310 in Children Patients With Moderate-to-severe Atopic Dermatis

NCT05579925CompletedPhase 2
Keymed Biosciences Co.Ltd
Posted 10/7/2022

A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)

NCT05724199CompletedPhase 3
Amgen
Posted 2/21/2023

A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis

NCT06407934RecruitingPhase 3
Sanofi
Posted 5/8/2024

GV20 Therapeutics Reports First Clinical Data for AI-Designed Checkpoint Inhibitor GV20-0251 in Advanced Solid Tumors

Monoclonal AntibodyOncologyAI
  • GV20 Therapeutics presented Phase 1 data for GV20-0251, marking the first clinical results for an AI-designed antibody targeting an AI-predicted immune checkpoint IGSF8.
  • The study enrolled 38 heavily pre-treated patients and demonstrated favorable safety with no dose-limiting toxicities across all dose levels from 0.5 to 20 mg/kg.
  • Two confirmed partial responses were observed in 12 evaluable metastatic cutaneous melanoma patients, with 14 of 29 patients showing stable disease including tumor shrinkage.
  • The drug showed dose-proportional pharmacokinetics with a 25.6-day half-life and full target occupancy on circulating T cells at doses ≥3 mg/kg.

A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies

NCT05669430RecruitingPhase 1
GV20 Therapeutics
Posted 3/23/2023

Roche's PiaSky Approved in EU as First Monthly Self-Administered Treatment for Paroxysmal Nocturnal Haemoglobinuria

Monoclonal AntibodyRare DiseaseDrug Approval
  • The European Commission has approved PiaSky (crovalimab), the first monthly subcutaneous treatment for paroxysmal nocturnal haemoglobinuria (PNH), offering patients the option to self-administer following training.
  • PiaSky utilizes innovative recycling antibody technology developed by Chugai Pharmaceutical, allowing it to bind to C5 protein multiple times and remain effective longer with a small volume of medicine.
  • Clinical trials demonstrated PiaSky's non-inferiority to eculizumab, the current standard of care, while potentially reducing treatment burden through less frequent administration and eliminating the need for regular clinic visits.

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)

NCT04861259Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 10/22/2021

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS)

NCT04958265Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 11/17/2021

A Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors

NCT04434092Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 10/8/2020

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors

NCT04432584Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 9/30/2020

Enzene Biosciences Establishes $50 Million New Jersey Manufacturing Facility with Continuous Biologics Platform

Monoclonal Antibody
  • Enzene Biosciences, a subsidiary of Alkem Laboratories, has opened a $50 million biopharmaceutical manufacturing facility in Hopewell, New Jersey, marking the company's first location outside India.
  • The 54,000-square-foot facility features EnzeneX™, the company's fully-connected continuous manufacturing platform validated for commercial biologics supply, aimed at reducing production costs.
  • The company appointed Norm Stoffregen as SVP and site head to lead operations, with plans to employ 300 workers by end of 2025 and expand bioreactor capacity.
  • Enzene aims to reduce monoclonal antibody production costs to below $40 per gram by 2025 through its innovative continuous manufacturing technology.

Citryll Completes Phase I Dosing for Novel Anti-Inflammatory Drug CIT-013 Targeting Neutrophil Extracellular Traps

Monoclonal Antibody
  • Citryll has successfully completed patient dosing in the repeat dose stage of its Phase I trial for CIT-013, a first-in-class therapeutic targeting neutrophil extracellular traps in inflammatory diseases.
  • The trial enrolled 9 rheumatoid arthritis patients and 3 healthy volunteers, with results expected in Q4 2024 that could enable Phase IIa studies.
  • CIT-013 offers a dual mechanism targeting citrullinated histones to both inhibit NET formation and promote clearance of existing NETs.
  • The company plans two Phase IIa studies in rheumatoid arthritis and hidradenitis suppurativa, positioning CIT-013 as a potential game-changer for inflammatory disorders.

Breakthrough Immunotherapy Combination Shows Promise Against Common Colorectal Cancer in Phase 1 Trial

Monoclonal Antibody
  • A phase 1 trial of 148 patients demonstrated that the combination of botensilimab and balstilimab immunotherapy drugs successfully treated microsatellite stable metastatic colorectal cancer, the most common form that has historically not responded to immunotherapy.
  • The study found that 61% of patients experienced tumor shrinkage or stabilization after six months of treatment, marking the first time consistent and durable responses to immunotherapy have been reported in this difficult-to-treat patient population.
  • The treatment was well-tolerated with common side effects including diarrhea and fatigue, and showed particular effectiveness in patients without liver metastases.
  • Agenus Inc. is planning to seek FDA approval and has initiated a phase 3 clinical trial, potentially offering new hope for colorectal cancer patients who face limited treatment options.

Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer

NCT03860272Active, Not RecruitingPhase 1
Agenus Inc.
Posted 3/20/2019

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