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Clinical Trial News

Accord BioPharma's Hercessi (trastuzumab-strf) Receives FDA Approval for 420mg Strength

• Accord BioPharma's Hercessi (trastuzumab-strf), a biosimilar to Herceptin, has received FDA approval for its 420mg strength, expanding treatment options for HER2-overexpressing cancers. • The approval includes indications for adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric or gastroesophageal junction adenocarcinoma. • Clinical data demonstrated Hercessi's similarity to Herceptin in efficacy, safety, and quality, supporting its use as a cost-effective alternative. • Accord BioPharma plans to commercially launch Hercessi in the U.S. in early 2025, adding to their growing portfolio of biosimilars aimed at reducing healthcare costs.

Biosyngen's BRG01 CAR-T Therapy Enters Phase II Trial for Nasopharyngeal Carcinoma After Promising Phase I Results

  • Biosyngen's BRG01, a novel CAR-T therapy targeting EBV antigens, has advanced to a pivotal Phase II trial for advanced nasopharyngeal carcinoma (NPC).
  • Phase I data revealed a 75% tumor reduction rate and progression-free survival exceeding six months in patients who had failed prior treatments.
  • The Phase I trial demonstrated a significant reduction in EBV viral load and a favorable safety profile with no dose-limiting toxicities or severe cytokine release syndrome.
  • BRG01 has received orphan drug and fast track designations from the FDA, highlighting its potential to address unmet needs in EBV-positive tumors.

MIRA Pharmaceuticals Advances Ketamir-2 Development for Neuropathic Pain

  • MIRA Pharmaceuticals has finalized the Phase 1 clinical trial design for Ketamir-2, an oral ketamine analog, with the trial slated to begin in early Q1 2025.
  • The company aims to file an Investigational New Drug (IND) application with the FDA in December 2024, supported by ongoing GLP toxicological studies.
  • MIRA prioritizes demonstrating clinical efficacy in humans by 2025, focusing on neuropathic pain and exploring potential applications in mental health disorders.
  • Drug product development of Ketamir-2 capsules has commenced in collaboration with Formulex to optimize oral bioavailability and patient convenience.

Satellos Bioscience Initiates Phase 1 Trial of SAT-3247 for Duchenne Muscular Dystrophy

  • Satellos Bioscience has dosed the first healthy volunteer in a Phase 1 clinical study of SAT-3247, an oral small molecule drug targeting AAK1.
  • The Phase 1 trial includes healthy volunteers to assess safety and pharmacokinetics, with initial data expected in Q4 2024.
  • A second component of the study, involving adult Duchenne muscular dystrophy (DMD) patients, is anticipated to begin in Q1 2025.
  • SAT-3247 aims to regenerate skeletal muscle in DMD patients, independent of dystrophin and genetic mutation status.

Telemedicine Study Accelerates for Pediatric Ear Conditions, Showing Promise for Reduced Wait Times

  • The ACCENTUATE study investigates telemedicine's feasibility for children with ear and hearing issues, potentially reducing waiting times and improving access to specialist care.
  • Researchers reached their recruitment target of 120 healthy volunteers in just one month, thanks to outstanding teamwork, accelerating the study's progress.
  • The study assesses children with glue ear and healthy volunteers using smartphone otoscopy, hearing tests, and middle ear pressure tests, reviewed remotely by ENT specialists.
  • Findings will inform a pilot teleotology service for children, with results shared with service users and the medical community, potentially transforming pediatric ENT care.

ALK+ Renal Cell Carcinoma Case Study Demonstrates Success of Precision Medicine Approach

  • A groundbreaking case study reveals remarkable 4-year response to alectinib in a patient with ALK-rearranged metastatic renal cell carcinoma, highlighting the importance of next-generation sequencing in treatment selection.
  • Research shows significant benefits of nivolumab plus ipilimumab combination therapy for patients with aggressive sarcomatoid RCC, offering a preferred first-line treatment option.
  • Updated KEYNOTE-564 trial data demonstrates overall survival benefit with adjuvant pembrolizumab in high-risk clear cell RCC patients post-nephrectomy, marking a crucial advancement in early-stage treatment.

Study of Pembrolizumab (MK-3475) Monotherapy in Locally Advanced/Metastatic Renal Cell Carcinoma (MK-3475-427/KEYNOTE-427)

NCT02853344CompletedPhase 2
Merck Sharp & Dohme LLC
Posted 9/30/2016

Safety and Efficacy Study of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (MK-3475-564/KEYNOTE-564)

NCT03142334Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 6/9/2017

A Study of Nivolumab In Combination With Cabozantinib in Patients With Non-Clear Cell Renal Cell Carcinoma

NCT03635892Active, Not RecruitingPhase 2
Memorial Sloan Kettering Cancer Center
Posted 8/13/2018

Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma

NCT05678673Active, Not RecruitingPhase 3
Exelixis
Posted 1/1/2023

A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer

NCT00375674CompletedPhase 3
Pfizer
Posted 8/1/2007

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

Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma

NCT02811861Active, Not RecruitingPhase 3
Eisai Inc.
Posted 10/13/2016

Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)

NCT02231749CompletedPhase 3
Bristol-Myers Squibb
Posted 10/16/2014

MannKind's Clofazimine Inhalation Suspension Phase 3 Trial for NTM Lung Disease Cleared in Japan

  • MannKind's ICoN-1 Phase 3 trial of Clofazimine Inhalation Suspension for NTM lung disease has been cleared by Japan's PMDA, expanding the trial globally.
  • The ICoN-1 trial is a multinational, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of the drug in refractory NTM lung disease.
  • The trial, already underway in the U.S., aims to enroll approximately 230 participants across multiple sites to assess sputum culture conversion and quality of life.
  • Clofazimine Inhalation Suspension has received Fast Track, Orphan Drug, and QIDP designations from the FDA, potentially granting market exclusivity upon approval.

ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension

NCT06418711RecruitingPhase 3
Mannkind Corporation
Posted 9/11/2024

Invion's INV043 Shows Promise in Phase II Prostate Cancer Trial

  • Invion's INV043, a photodynamic technology, demonstrated a positive response in approximately 40% of participants in a Phase II prostate cancer trial.
  • The trial showed 10% of participants experienced complete regression based on RECIST 1.1 criteria, with mild side effects reported.
  • 44% of participants achieved negative PSMA-PET results three months post-treatment, suggesting potential efficacy in targeting prostate cancer.
  • A clinical study summary recommends further investigation of INV043 due to its favorable safety profile and promising preliminary efficacy results.

Emerging IL-17 Inhibitors Show Promise in Hidradenitis Suppurativa Treatment

  • Bimekizumab, an IL-17 A and F blocker, shows promising data for hidradenitis suppurativa (HS) treatment, offering a potential advancement in patient care.
  • Secukinumab, an anti-IL17A biologic drug, has recently been approved and demonstrates superiority versus placebo in clinical trials for HS.
  • Innovative nanobody delivery methods targeting IL-17 A and F are under development, potentially improving molecule penetration and treatment efficacy.
  • The approval of secukinumab and the development of other anti-IL-17 therapies signify a shift towards more effective HS treatments compared to adalimumab.

This is a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS).

NCT03713619CompletedPhase 3
Novartis Pharmaceuticals
Posted 1/31/2019

Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS)

NCT03713632CompletedPhase 3
Novartis Pharmaceuticals
Posted 2/25/2019

Keytruda Extends Cancer-Free Survival in High-Risk Bladder Cancer Patients Post-Surgery

• Keytruda (pembrolizumab) significantly extends cancer-free survival in patients with high-risk, muscle-invasive bladder cancer after surgery, compared to observation. • Patients receiving post-operative Keytruda experienced nearly 30 months of cancer-free survival, doubling the 14 months observed in the monitoring-only group. • The benefit of Keytruda was more pronounced in patients with PD-L1-positive tumors, showing almost 37 months of cancer-free survival. • This trial supports Keytruda as a valuable post-surgical treatment option, especially for those who cannot tolerate cisplatin chemotherapy.

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