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Clinical Trial News

Amgen Presents Early-Stage Clinical Trial Data at ESMO 2024, Showcasing Oncology Pipeline

• Amgen is presenting data from early-stage trials at ESMO 2024, highlighting targeted therapies for various cancers, including colorectal, lung, prostate, and gastric, showcasing the breadth of their oncology pipeline. • The CodeBreaK 101 study reveals initial findings of LUMAKRAS combined with Vectibix and FOLFIRI as a first-line treatment for KRAS G12C-mutated metastatic colorectal cancer. • First-in-human study results of xaluritamig in metastatic castration-resistant prostate cancer are being presented, alongside Phase 1 data for AMG 193 in MTAP-deleted solid tumors. • Additional data includes long-term outcomes of sotorasib in pre-treated KRAS G12C-mutated advanced NSCLC and biomarker analysis for bemarituzumab in advanced gastric cancers.

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

NCT04185883RecruitingPhase 1
Amgen
Posted 12/17/2019

A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment

NCT04933695CompletedPhase 2
Amgen
Posted 1/28/2022

TransCon IL-2 β/γ Shows Promise in Platinum-Resistant Ovarian Cancer

  • Ascendis Pharma's TransCon IL-2 β/γ demonstrated anti-tumor activity in 29% of efficacy-evaluable patients with platinum-resistant ovarian cancer (PROC).
  • The Phase 1/2 IL-Believe trial data suggests clinical benefit in heavily pre-treated PROC patients, including those who progressed on Elahere.
  • The combination of TransCon IL-2 β/γ and chemotherapy was generally well-tolerated, with mostly grade 1 or 2 treatment-emergent adverse events.
  • These findings, presented at ESMO 2024, indicate potential efficacy across multiple cancer types, building on previous results in melanoma.

Marengo Therapeutics and Gilead Sciences Collaborate to Evaluate Combination Therapy for Metastatic Breast Cancers

  • Marengo Therapeutics and Gilead Sciences will evaluate the combination of STAR0602 (Invikafusp alfa) and Trodelvy in metastatic TNBC and HR+/HER2- breast cancers.
  • The Phase I/II clinical trial, START-002, will assess the safety, tolerability, and preliminary efficacy of the combination therapy.
  • Marengo will sponsor the trial, and Gilead will supply Trodelvy, with both companies retaining rights to their respective compounds.
  • Invikafusp alfa has shown single-agent clinical activity in PD-1 resistant cancers, suggesting potential synergy with Trodelvy.

A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors

NCT05592626RecruitingPhase 1
Marengo Therapeutics, Inc.
Posted 1/4/2023

Millions of Americans Could Benefit from Psilocybin Therapy for Depression, Study Suggests

  • A recent study estimates that 5.1 to 5.6 million Americans with depression could be eligible for psilocybin-assisted therapy if approved by the FDA.
  • The research analyzed national survey data and clinical trial criteria to project the potential demand for this novel treatment.
  • The study highlights the importance of addressing practical considerations like insurance coverage and practitioner availability for widespread implementation.
  • Researchers caution that the projections depend on FDA approval parameters and real-world factors, emphasizing the need for further research.

Moderna's mRNA Cancer Vaccine Shows Early Promise in Solid Tumors

  • Moderna's mRNA-4359 cancer vaccine demonstrates early signs of stimulating the immune system against advanced solid tumors in a Phase I/II trial.
  • The vaccine was well-tolerated, with no serious side effects, and showed tumor growth stabilization in a subset of patients evaluated.
  • The study is now enrolling patients with melanoma and non-small cell lung cancer to assess the vaccine's efficacy in combination with pembrolizumab.
  • These early results represent an important step in developing new treatments for advanced cancers, though further studies are needed to confirm efficacy.

Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors

NCT05533697RecruitingPhase 1
ModernaTX, Inc.
Posted 8/18/2022

Atea's Bemnifosbuvir Fails to Meet Primary Endpoint in Phase 3 COVID-19 Trial

  • Atea Pharmaceuticals' Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir for COVID-19 treatment did not meet its primary endpoint of reducing all-cause hospitalization or death.
  • The global, randomized, double-blind, placebo-controlled trial involved 2,221 high-risk patients with mild to moderate COVID-19 receiving bemnifosbuvir or placebo.
  • Bemnifosbuvir was generally safe and well-tolerated in the SUNRISE-3 trial, but the company will not pursue a regulatory pathway forward for COVID-19.
  • Atea remains focused on developing bemnifosbuvir in combination with ruzasvir for hepatitis C treatment, with additional Phase 2 results expected in Q4 2024.

IRA Implementation Reshapes Cancer Drug Development and Patient Access Landscape

  • The Inflation Reduction Act's Medicare price negotiation rules are driving pharmaceutical companies to reconsider development strategies, potentially limiting access to drugs for smaller patient populations.
  • Starting January 2024, IRA's benefit design changes will cap out-of-pocket costs at $2000 and introduce payment smoothing, significantly improving cancer treatment affordability for patients.
  • Drug shortages continue to pose critical challenges in oncology care, with experts warning about the risks of limited manufacturing facilities for essential generic medications.

GSK's Blenrep Receives Breakthrough Therapy Designation in China and Japan Review for Multiple Myeloma

  • GSK's Blenrep (belantamab mafodotin) gains Breakthrough Therapy Designation in China for relapsed or refractory multiple myeloma when combined with bortezomib plus dexamethasone.
  • The designation is based on Phase III DREAMM-7 trial results, demonstrating statistically significant improvements in progression-free survival compared to daratumumab plus BorDex.
  • Japan's health authority also accepted Blenrep for review in combination with BorDex or PomDex, supported by DREAMM-7 and DREAMM-8 trial data, offering new hope for patients.
  • Multiple myeloma incidence is rising in China and Japan, underscoring the need for novel treatments like Blenrep to address resistance to standard therapies.

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

Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

NCT04246047Active, Not RecruitingPhase 3
GlaxoSmithKline
Posted 5/7/2020

Psychedelic Therapy Clinical Trials Show CNS Focus and Rise in Phase II Studies

  • A new report analyzes the increasing number of psychedelic therapy clinical trials, highlighting key trends in sponsor types, geographic distribution, and trial phases.
  • Non-industry sponsors, such as Yale University, lead in the number of psychedelic therapy trials, particularly for central nervous system (CNS) indications like depression.
  • The United States is the leading country for psychedelic therapy trials in North America, with Phase II trials outnumbering other phases since 2013.
  • The report identifies top psychedelic therapies and drugs, offering insights into trial designs, virtual components, and likelihood of approval.

Medication Review Trial Aims to Enhance Quality of Life for Elderly with Polypharmacy

  • A new trial is underway to assess the impact of structured medication reviews on the health-related quality of life (HRQoL) in older adults with polypharmacy.
  • The intervention involves clinical assessment, geriatrician supervision, and collaboration between hospital physicians and general practitioners to optimize medication plans.
  • The primary outcome is HRQoL measured by the 15D instrument at 16 weeks, with secondary outcomes including physical and cognitive function, falls, and healthcare utilization.
  • The study aims to recruit 350 patients to detect a clinically significant difference in HRQoL, contributing to improved care strategies for elderly patients.

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