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Clinical Trial News

AbbVie's Temab-A ADC Shows 63% Response Rate in EGFR-Mutated NSCLC Phase I Trial

  • AbbVie's antibody drug conjugate Temab-A achieved a 63% overall response rate in patients with advanced EGFR-mutated non-small cell lung cancer in Phase I trial results presented at ASCO 2025.
  • The drug demonstrated a median duration of response of 9.8 months and median progression-free survival of 10.9 months in 41 enrolled patients who had progressed after platinum-based chemotherapy and tyrosine kinase inhibitors.
  • Treatment-emergent adverse events occurred in all patients, with 78% experiencing grade 3 or higher serious events, including a 7% rate of interstitial lung disease.
  • The results position Temab-A as a potential competitor in the growing NSCLC market, which is projected to reach $45.4 billion by 2031 according to GlobalData.

A Study Assessing Adverse Events and Disease Activity When Comparing Intravenously (IV) Infused ABBV-400 to Trifluridine and Tipiracil (LONSURF) Oral Tablets Plus IV Infused Bevacizumab in Adult Participants With c-Met Protein Above Cutoff Level Above Refractory Metastatic Colorectal Cancer

NCT06614192RecruitingPhase 3
AbbVie
Posted 11/8/2024

Study to Assess Adverse Events and Change in Disease Activity in Previously Treated Adult Participants Receiving Intravenous (IV) ABBV-400 With Unresectable Metastatic Colorectal Cancer in Combination With IV Fluorouracil, Folinic Acid, and Bevacizumab

2023-505110-14-00RecruitingPhase 2
AbbVie Deutschland GmbH & Co. KG
Posted 11/12/2023

Study to Evaluate Adverse Events and Efficacy of Intravenous (IV) Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations

NCT06772623RecruitingPhase 1
AbbVie
Posted 3/6/2025

AMPLITUDE Trial Shows Niraparib Combination Reduces Cancer Progression Risk by 37% in HRR-Mutant Metastatic Prostate Cancer

  • The phase III AMPLITUDE trial demonstrated that adding niraparib to abiraterone acetate plus prednisone significantly improved radiographic progression-free survival in patients with metastatic castration-sensitive prostate cancer harboring HRR gene alterations.
  • Niraparib combination therapy reduced the risk of cancer growth by 37% overall and by 48% specifically in patients with BRCA1 or BRCA2 mutations compared to standard treatment alone.
  • The study enrolled 696 patients with a median age of 68 years, with more than half having BRCA1 or BRCA2 alterations, representing approximately 25% of the metastatic prostate cancer population.
  • While showing efficacy benefits, the niraparib group experienced higher rates of serious adverse effects (75.2% vs 58.9%) and treatment discontinuation (15% vs 10%) compared to placebo.

A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

NCT04497844Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 9/23/2020

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

Sanofi's Sarclisa Shows Non-Inferior Efficacy with Novel On-Body Injector in Phase 3 Multiple Myeloma Trial

Monoclonal Antibody
  • The IRAKLIA phase 3 study demonstrated that Sarclisa administered subcutaneously via an on-body injector achieved non-inferior efficacy compared to intravenous infusion, with objective response rates of 71.1% versus 70.5% respectively.
  • Patients receiving subcutaneous Sarclisa experienced significantly fewer systemic infusion reactions (1.5% versus 25%) and reported higher satisfaction rates (70% versus 53.4%) compared to intravenous administration.
  • The innovative delivery system using Enable Injections' enFuse device successfully delivered 99.9% of injections with no significant safety concerns, potentially transforming multiple myeloma treatment administration.
  • Data from both IRAKLIA and IZALCO studies will form the basis for global regulatory submissions across all currently approved treatment lines for multiple myeloma.

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

Lenalidomide, Bortezomib and Dexamethasone Induction Therapy with Either Intravenous or Subcutaneous Isatuximab in Patients with Newly Diagnosed Multiple Myeloma

NCT05804032Active, Not RecruitingPhase 3
University of Heidelberg Medical Center
Posted 4/14/2023

Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients

NCT02990338CompletedPhase 3
Sanofi
Posted 12/22/2016

Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma

NCT02252172CompletedPhase 3
Janssen Research & Development, LLC
Posted 2/16/2015

Multi-center, Open-label, Phase 1b Study in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)

NCT04045795CompletedPhase 1
Sanofi
Posted 8/6/2019

A Study to Investigate the Clinical Benefit of Isatuximab in Combination With Bortezomib, Lenalidomide and Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

NCT03319667Active, Not RecruitingPhase 3
Sanofi
Posted 12/7/2017

SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM

NCT05405166Active, Not RecruitingPhase 3
Sanofi
Posted 6/23/2022

A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma

NCT05704049RecruitingPhase 2
Sanofi
Posted 4/5/2023

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

A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma

NCT06356571RecruitingPhase 2
Sanofi
Posted 3/17/2025

Matter Neuroscience Partners with Stanford Medicine to Test Novel fMRI-Guided Depression Therapy

  • Matter Neuroscience has announced a collaboration with Stanford Medicine to conduct a controlled, multi-arm study enrolling at least 210 depressed patients using real-time 7T fMRI neurofeedback combined with the Matter protocol.
  • The study aims to significantly reduce clinical endpoints by selectively activating key brain areas hosting distinct positive emotions, with clinical endpoints paralleled by molecular, emotional and behavioral biomarkers.
  • If successful, the findings could be integrated into a full-scale clinical trial with potential to inform future non-pharmaceutical curative therapies for depression.
  • The research will be led by Professor Nolan Williams, M.D., Associate Professor of Psychiatry and Behavioral Sciences at Stanford University and Director of the Stanford Brain Stimulation Lab.

Catalyst Pharmaceuticals Appoints Dr. William Andrews as Chief Medical Officer to Lead Rare Disease Strategy

  • Catalyst Pharmaceuticals appointed Dr. William T. Andrews as Chief Medical Officer, succeeding retiring Dr. Gary Ingenito after his successful 10-year tenure with the company.
  • Dr. Andrews brings 24 years of global biopharmaceutical experience with 18 years specifically focused on rare diseases, having previously served as CMO at multiple biotech companies.
  • The leadership change coincides with strong financial performance, including a 13% stock price increase over the last quarter and 443.67% total return over five years.
  • The appointment aims to strengthen Catalyst's strategic direction in rare diseases and support continued growth of key products AGAMREE and FIRDAPSE.

Researchers Develop Trans-Amplifying mRNA Vaccine Platform with 40-Fold Dose Reduction and Broad Viral Protection

  • Researchers at University of Pittsburgh and Penn State developed a novel "trans-amplifying" mRNA vaccine platform that requires 40 times less mRNA than conventional vaccines while maintaining robust immune responses.
  • The innovative approach separates mRNA into two fragments, allowing the replicase sequence to be produced in advance and significantly reducing vaccine development time and production costs.
  • The vaccine uses a consensus spike protein design that demonstrated broad protection against multiple SARS-CoV-2 variants in mouse studies, potentially eliminating the need for frequent updates.
  • The platform shows promise for application to other rapidly evolving RNA viruses with pandemic potential, including H5N1 avian influenza.

A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19

NCT04470427CompletedPhase 3
ModernaTX, Inc.
Posted 7/27/2020

Minerva Biotechnologies Advances MUC1*-Targeted CAR-T Therapy with 1XX Mutations for Solid Tumors

CAR-T
  • Minerva Biotechnologies published research demonstrating that MUC1*-targeted CAR-T cells with 1XX mutations show increased persistence and ability to kill low antigen-expressing cancer cells in animal models.
  • The novel MUC1* target is a cancer-specific growth factor receptor expressed on 75% of solid tumors, representing a significant advancement after 30 years without FDA-approved MUC1-targeting therapeutics.
  • The company has received FDA approval for an IND application for MUC1*-CAR22, which demonstrates longer in vivo persistence for more durable solid tumor treatment responses.

Kamari Pharma Secures $23 Million Series A to Advance First-in-Class TRPV3 Inhibitor for Rare Genetic Skin Diseases

Rare Disease
  • Kamari Pharma closed a $23 million Series A financing co-led by BRM Group and Pontifax to advance KM023, a first-in-class oral TRPV3 inhibitor for rare genetic skin diseases.
  • The lead program KM023 targets three rare genetic skin conditions: Olmsted syndrome, severe keratoderma, and ichthyosis, with proof-of-concept trials planned for each indication.
  • The company plans to initiate a Phase 1b clinical trial for Olmsted syndrome in the second half of 2025, with top-line results expected by year-end.
  • TRPV3 inhibition represents a novel therapeutic approach in rare dermatology, targeting a key regulator in skin disease pathways.

Rigosertib Achieves 80% Response Rate in First Clinical Trial for Rare RDEB-Associated Skin Cancer

Rare DiseaseOncologyOrphan Drug
  • Rigosertib demonstrated an 80% overall response rate with 50% complete responses in the first-ever clinical trial for RDEB-associated squamous cell carcinoma, published in the British Journal of Dermatology.
  • The trial addressed a critical unmet medical need in recessive dystrophic epidermolysis bullosa patients who develop aggressive skin cancers with cumulative death risks of 70% and 78.7% by ages 45 and 55, respectively.
  • Traws Pharma is actively seeking development and commercialization partners for rigosertib, a small molecule PLK-1 kinase inhibitor, as no approved therapies currently exist for this devastating condition.

Rigosertib for RDEB-SCC

NCT03786237RecruitingPhase 1
Prof. Johann Bauer
Posted 4/12/2021

Rigosertib in Patients With Recessive Dystrophic Epidermolysis Bullosa Associated SCC

NCT04177498CompletedEarly Phase 1
Thomas Jefferson University
Posted 8/24/2021

Japanese Researchers Launch Final Phase Trial of Bromocriptine for Familial Alzheimer's Disease

  • Towa Pharmaceutical and Kyoto University have initiated the final phase of a clinical trial testing bromocriptine, a Parkinson's drug, as a potential treatment for familial Alzheimer's disease using innovative iPS drug discovery methods.
  • The trial, running until March 2028, will enroll 24 patients with familial Alzheimer's disease caused by specific gene mutations, with preliminary results showing no disease-specific side effects and potential suppression of cognitive decline.
  • This represents a novel approach to treating early-onset familial Alzheimer's disease, a rare form affecting individuals under 60, for which no cure currently exists despite available symptomatic treatments.

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