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MSD Expands Opevesostat Clinical Program to Include Breast, Endometrial, and Ovarian Cancers

Oncology
  • MSD has initiated a new Phase 2 clinical trial to evaluate opevesostat (MK-5684) in women's cancers, expanding beyond its current prostate cancer program.
  • Opevesostat, an oral, non-steroidal and selective CYP11A1 inhibitor discovered by Orion, will be tested for safety and efficacy in breast, endometrial, and ovarian cancers.
  • The expansion represents a significant broadening of potential therapeutic applications for opevesostat, which is already in Phase 3 trials for metastatic castration-resistant prostate cancer.

A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015)

NCT06979596RecruitingPhase 2
Merck Sharp & Dohme LLC
Posted 8/11/2025

Tubulis and Bristol Myers Squibb Advance First Collaborative Tubutecan ADC into Clinical Trials

Oncology
  • Tubulis announced that the first antibody-drug conjugate from its strategic partnership with Bristol Myers Squibb has entered clinical development, marking a significant milestone in their 2023 collaboration agreement.
  • The ADC candidate leverages Tubulis' proprietary Tubutecan technology, which combines their P5 conjugation system with an exatecan payload to create stable, targeted cancer therapeutics with minimized systemic toxicity.
  • This represents the third Tubutecan-based ADC to reach clinical trials within 12 months, following Tubulis' wholly owned programs TUB-030 and TUB-040, demonstrating the platform's versatility for treating solid tumors.

Genomic Testing Emerges as Critical Tool in Brain Cancer Treatment, Experts Emphasize

OncologyTargeted TherapyDrug Approval
  • Comprehensive genomic profiling is crucial for brain cancer patients, enabling personalized treatment approaches and identification of actionable mutations like NTRK fusions, according to Dr. Manmeet Ahluwalia.
  • The recent FDA approval of vorasidenib (Voranigo) for IDH-mutant gliomas represents a breakthrough in targeted therapy for brain tumors and provides hope for developing additional brain-penetrating drugs.
  • Clinical trials remain the optimal treatment option for aggressive brain cancers like glioblastoma, with increasing availability in both academic centers and larger community practices.

Novel IL-2 Derivative Shows Complete Remission in Advanced Skin Cancer Patient After One Year

OncologyTargeted Therapy
• A 73-year-old patient with advanced cutaneous squamous cell carcinoma has remained cancer-free for over a year following treatment with WTX-124, a novel conditionally activated IL-2 pro-drug, in a clinical trial at HonorHealth Research Institute.
• The investigational drug is engineered to remain inactive until it reaches the tumor microenvironment, potentially delivering the benefits of IL-2 therapy with significantly reduced toxicity compared to conventional treatments.
• This breakthrough offers new hope for the nearly 40,000 U.S. patients annually who develop advanced cutaneous squamous cell carcinoma, particularly those who have failed standard treatments including checkpoint inhibitor therapy.

FDA Advisory Committee Votes 6-2 in Favor of Daratumumab for High-Risk Smoldering Multiple Myeloma

Monoclonal AntibodyOncology
  • The FDA's Oncologic Drug Advisory Committee (ODAC) voted 6-2 that daratumumab (Darzalex Faspro) demonstrates a favorable benefit-risk profile for patients with high-risk smoldering multiple myeloma, potentially offering the first approved therapy for this precursor condition.
  • The phase 3 AQUILA trial showed daratumumab significantly delayed progression to active multiple myeloma with a 51% reduction in risk of progression or death compared to active monitoring, with 5-year PFS rates of 63.1% versus 40.8%.
  • Committee members expressed concerns about risk classification accuracy and potential overtreatment, but ultimately determined the benefits outweighed risks for this malignant condition that has an 80% five-year progression risk to symptomatic multiple myeloma.

A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma

NCT03301220Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 11/7/2017

Daratumumab, VELCADE (Bortezomib), Lenalidomide and Dexamethasone Compared to VELCADE, Lenalidomide and Dexamethasone in Subjects With Previously Untreated Multiple Myeloma

NCT03710603Active, Not RecruitingPhase 3
Stichting European Myeloma Network
Posted 12/14/2018

A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

NCT03652064Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 11/6/2018

FDA Advisory Committee Rejects New Indications for Genentech's Columvi and Pfizer's Talzenna Combination

Oncology
• The FDA's Oncologic Drugs Advisory Committee voted 8-1 against approving Genentech's Columvi for a new indication, citing concerns about the pivotal trial's applicability to US patients.
• In a separate decision, the same committee unanimously rejected (8-0) Pfizer's application for Talzenna in combination with Xtandi for first-line treatment in adults with prostate cancer.
• These negative recommendations highlight the FDA's increasing scrutiny of oncology drug applications and may signal stricter requirements for clinical trial design and population representation.

Poolbeg Pharma Secures £4.1 Million Fundraising to Advance Clinical Programs in Oncology and Obesity

OncologyAICAR-T
  • Poolbeg Pharma has announced a £4.1 million conditional fundraising to advance its POLB 001 Phase 2a trial for cancer immunotherapy-induced Cytokine Release Syndrome and oral GLP-1 proof of concept trial for obesity.
  • The fundraising comprises a £2.655 million placing, £1.345 million in direct subscriptions, and up to £100,000 from a retail offer, with shares issued at 2.5 pence each, representing a 12% discount to the previous closing price.
  • The proceeds will extend Poolbeg's cash runway into 2027, supporting multiple near-term clinical data catalysts including first patient dosing for POLB 001 in H2 2025 and topline data expected in H2 2026.

CCM Biosciences to Present Breakthrough 4th-Generation EGFR Inhibitors for NSCLC at ASCO 2025

OncologyPrecision MedicineTargeted Therapy
  • CCM Biosciences will present data on novel 4th-generation EGFR inhibitors (CCM-205, CCM-245, and CCM-308) that overcome both mutational and non-mutational resistance to 3rd-generation inhibitors in NSCLC at ASCO 2025.
  • The company's compounds significantly outperform other investigational 4th-generation inhibitors in various drug resistance models and show efficacy as both monotherapies and in combination with existing treatments.
  • CCM Biosciences plans to file an Investigational New Drug (IND) application this year to advance clinical candidates from its EGFR inhibitor program into clinical trials.

TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations

NCT04129502Active, Not RecruitingPhase 3
Takeda
Posted 1/10/2020

A Phase 1/2 Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer

NCT04036682Active, Not RecruitingPhase 1
Cullinan Therapeutics Inc.
Posted 10/31/2019

Efficacy and Safety of Almonertinib Combined With or Without Chemotherapy as an Adjuvant Treatment for Stage II-IIIA Non-small Cell Lung Carcinoma Following Complete Tumour Resection

NCT04762459Enrolling by InvitationPhase 3
Chinese Academy of Medical Sciences
Posted 8/1/2021

Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer with EGFR or HER2 Mutation (WU-KONG1)

NCT03974022Active, Not RecruitingPhase 1
Dizal Pharmaceuticals
Posted 7/9/2019

To Assess the Efficacy and Safety of Furmonertinib Versus Placebo, in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage II-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy

NCT04853342RecruitingPhase 3
Allist Pharmaceuticals, Inc.
Posted 6/7/2021

A Study of TAVO412 in Patients with Cancer (TAVO412)

NCT06761651RecruitingPhase 1
Tavotek Biotherapeutics
Posted 12/20/2023

Study to Compare Furmonertinib to Platinum-Based Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)

NCT05607550Active, Not RecruitingPhase 3
ArriVent BioPharma, Inc.
Posted 6/1/2023

Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer

NCT02609776Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 5/24/2016

AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

NCT02296125Active, Not RecruitingPhase 3
AstraZeneca
Posted 12/3/2014

Study of Osimertinib With and Without Ramucirumab in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

NCT03909334Active, Not RecruitingPhase 2
Xiuning Le
Posted 7/25/2019

A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure

NCT04988295Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 11/17/2021

A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy)

NCT02912949Active, Not RecruitingPhase 2
Partner Therapeutics, Inc.
Posted 1/1/2015

Evaluating High-dose Furmonertinib with Bevacizumab and Pemetrexed for EGFRm NSCLC with Leptomeningeal Metastasis

NCT06643000RecruitingNot Applicable
Henan Cancer Hospital
Posted 12/20/2024

A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer

NCT05388669Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 8/5/2022

A trial to learn how safe Dato-DXd is when given with osimertinib, and how well it works compared to osimertinib alone in people who have advanced or metastatic non-small cell lung cancer (NSCLC) with a mutation in the EGFR gene

2023-509883-89-00RecruitingPhase 3
AstraZeneca AB
Posted 4/29/2024

Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)

NCT03944772Active, Not RecruitingPhase 2
AstraZeneca
Posted 6/25/2019

A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection

NCT05120349Active, Not RecruitingPhase 3
AstraZeneca
Posted 2/21/2022

A Global Study to Assess the Effects of Osimertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer (LAURA)

NCT03521154Active, Not RecruitingPhase 3
AstraZeneca
Posted 7/19/2018

Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer

NCT04181060RecruitingPhase 3
National Cancer Institute (NCI)
Posted 12/28/2020

A trial to learn how safe Dato-DXd is and how well it works in people with NSCLC that has advanced after receiving osimertinib

2024-511362-37-00RecruitingPhase 3
AstraZeneca AB
Posted 10/4/2024

AK112 in Advanced Non-Small Cell Lung Cancer

NCT05499390Active, Not RecruitingPhase 3
Akeso
Posted 11/9/2022

Almonertinib Plus Chemotherapy as First-line Treatment in Patients With EGFR Concomitant Tumor Suppressor Gene Mutation

NCT04500717Unknown StatusPhase 3
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Posted 10/1/2020

A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions

NCT04538664Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 10/13/2020

A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer

NCT04077463Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 9/4/2019

Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)

NCT01942135CompletedPhase 3
Pfizer
Posted 9/26/2013

Icotinib Following Chemotherapy Versus Chemotherapy as Adjuvant Therapy in Stage IIA-IIIA NSCLC With EGFR Mutation

NCT01996098Unknown StatusPhase 3
Sun Yat-sen University
Posted 1/1/2014

Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma

NCT02125240Unknown StatusPhase 3
Betta Pharmaceuticals Co., Ltd.
Posted 9/1/2014

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT04487080Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 9/30/2020

REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors)

NCT05973773RecruitingPhase 3
Taiho Oncology, Inc.
Posted 6/30/2023

Adjuvant Befotertinib in Stage IB-IIIB Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations

NCT06041776RecruitingPhase 3
Betta Pharmaceuticals Co., Ltd.
Posted 3/28/2023

Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib

NCT06120140RecruitingPhase 2
Janssen Research & Development, LLC
Posted 2/16/2024

Docetaxel + Plinabulin Compared to Docetaxel + Placebo in Patients With Advanced NSCLC

NCT02504489CompletedPhase 3
BeyondSpring Pharmaceuticals Inc.
Posted 12/1/2015

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

NCT05663866Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 5/18/2023

A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2)

NCT04035486Active, Not RecruitingPhase 3
AstraZeneca
Posted 7/2/2019

FDA Advisory Committee Rejects Genentech's Columvi Expansion for Transplant-Ineligible DLBCL Patients

Oncology
  • The FDA's Oncologic Drugs Advisory Committee voted 8-1 against expanding Genentech's bispecific antibody Columvi for transplant-ineligible patients with relapsed/refractory diffuse large B-cell lymphoma.
  • Committee members expressed concerns about the applicability of the Phase III STARGLO study data to the U.S. population, as half of the participants were Asian patients with only 25 enrolled from North America.
  • Columvi, which targets CD20 and CD3 proteins, was initially approved in June 2023 for DLBCL patients who had undergone at least two prior lines of systemic therapy.

Glofitamab-GemOx Shows Survival Benefit in Phase 3 STARGLO Trial for R/R DLBCL, But FDA Advisory Committee Questions US Applicability

Oncology
  • The phase 3 STARGLO trial demonstrated that glofitamab combined with gemcitabine and oxaliplatin nearly doubled median overall survival to 25.5 months compared with 12.9 months for rituximab-GemOx in transplant-ineligible R/R DLBCL patients.
  • Despite showing a 41% reduction in death risk and 63% reduction in disease progression, the FDA's Oncologic Drugs Advisory Committee voted 8-to-1 against the applicability of the trial data to US patients, citing regional outcome differences.
  • Glofitamab, a CD20xCD3 bispecific antibody, is currently approved in over 30 countries and has accelerated approval in the US, with an FDA decision on full approval expected by July 20, 2025.

A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer

NCT03748641Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 1/25/2019

First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia

NCT04067336RecruitingPhase 1
Kura Oncology, Inc.
Posted 9/12/2019

Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)

NCT05501886RecruitingPhase 3
Celcuity Inc
Posted 12/8/2022

A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

NCT04688931TerminatedPhase 3
UroGen Pharma Ltd.
Posted 2/19/2021

A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Participants With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy

NCT02993523Active, Not RecruitingPhase 3
AbbVie
Posted 2/2/2017

An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions

NCT04717414Active, Not RecruitingNot Applicable
Celgene
Posted 2/25/2021

Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies

NCT02290951CompletedPhase 1
Regeneron Pharmaceuticals
Posted 1/9/2015

Pre-emptive Daratumumab Therapy of Minimal Residual Disease Reappearance or Biochemical Relapse in Multiple Myeloma

NCT03697655Unknown StatusPhase 2
Polish Myeloma Consortium
Posted 12/10/2018

Pembrolizumab Plus Lenvatinib for First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (1L nccRCC) (MK-3475-B61)

NCT04704219Active, Not RecruitingPhase 2
Merck Sharp & Dohme LLC
Posted 2/23/2021

A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Adult Patients With B-cell Non-Hodgkin Lymphoma Who Have Been Previously Treated With Other Cancer Therapies

NCT03888105RecruitingPhase 2
Regeneron Pharmaceuticals
Posted 11/13/2019

Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC

NCT03395197Active, Not RecruitingPhase 3
Pfizer
Posted 12/18/2017

A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

NCT04408638Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 2/23/2021

MInimal Residual Disease Adapted Strategy

NCT04934475Active, Not RecruitingPhase 3
Intergroupe Francophone du Myelome
Posted 12/8/2021

Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL

NCT03836261Active, Not RecruitingPhase 3
Acerta Pharma BV
Posted 2/25/2019

Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer

NCT04592913Active, Not RecruitingPhase 3
AstraZeneca
Posted 11/17/2020

An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma

NCT06047080RecruitingPhase 3
Hoffmann-La Roche
Posted 9/18/2023

A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma

NCT03301220Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 11/7/2017

A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

NCT05243550Active, Not RecruitingPhase 3
UroGen Pharma Ltd.
Posted 3/1/2022

A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma

NCT03075696RecruitingPhase 1
Hoffmann-La Roche
Posted 2/21/2017

A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

NCT04182204CompletedPhase 3
Hoffmann-La Roche
Posted 2/7/2020

THIO Sequenced With Cemiplimab in Advanced NSCLC

NCT05208944RecruitingPhase 2
Maia Biotechnology
Posted 6/8/2022

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