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Clinical Trial News

Henlius Presents Comprehensive Serplulimab Data at ASCO 2025, Demonstrating Broad Efficacy Across Multiple Cancer Types

Monoclonal Antibody
  • Shanghai Henlius Biotech presented results from over ten studies of serplulimab (HANSIZHUANG) at the 2025 ASCO Annual Meeting, covering lung and gastrointestinal cancers with promising efficacy data.
  • The phase 3 ASTRUM-005 trial showed serplulimab plus chemotherapy achieved a median overall survival of 15.8 months versus 11.1 months for placebo in extensive-stage small cell lung cancer patients.
  • Multiple combination studies demonstrated high objective response rates, including 92% ORR in HER2-positive gastric cancer and 74.47% ORR in metastatic pancreatic cancer when combined with targeted therapies.
  • Real-world studies across various cancer types confirmed the safety profile and clinical effectiveness of serplulimab-based treatments in diverse patient populations.

Efficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric/Gastroesophageal Junction Adenocarcinoma

NCT06461910RecruitingPhase 2
Zekuan Xu
Posted 6/14/2024

SBRT Addition to Nivolumab-Ipilimumab Fails to Improve Outcomes in Metastatic Castration-Resistant Prostate Cancer

  • The phase 2 CheckPRO trial demonstrated that nivolumab plus ipilimumab showed clinical activity in metastatic castration-resistant prostate cancer patients with PSA response rates of approximately 21%.
  • Adding stereotactic body radiation therapy (SBRT) to the immunotherapy combination was well tolerated but did not enhance treatment efficacy across key endpoints.
  • Both treatment arms showed similar progression-free survival of approximately 2.5 months and overall survival of around 9-10 months in heavily pretreated patients.
  • The study highlights the need for further research to identify which mCRPC patients are most likely to respond to immune checkpoint inhibitor therapy.

Checkpoint Inhibitors and SBRT for MCRPC

NCT05655715CompletedPhase 2
Herlev and Gentofte Hospital
Posted 11/25/2019

Arrowhead Pharmaceuticals Launches First-in-Human Trial of ARO-ALK7 for Obesity Treatment

  • Arrowhead Pharmaceuticals has dosed the first subjects in a Phase 1/2a clinical trial of ARO-ALK7, marking the first investigational RNAi therapeutic to target a gene expressed in adipose tissue for obesity treatment.
  • ARO-ALK7 is designed to silence the ACVR1C gene to reduce production of Activin receptor-like kinase 7 (ALK7), which regulates energy homeostasis in adipose tissue and signals the body to store fat.
  • The study will evaluate single and multiple ascending doses of ARO-ALK7 as monotherapy in healthy obese volunteers, followed by combination therapy with tirzepatide in obese patients with and without type 2 diabetes.
  • Preclinical animal studies demonstrated that ALK7 silencing in adipose tissue led to reduced body weight and fat mass while preserving lean muscle mass.

Study of ARO-ALK7 in Adult Volunteers With Obesity With and Without Type 2 Diabetes Mellitus

NCT06937203RecruitingPhase 1
Arrowhead Pharmaceuticals
Posted 5/7/2025

Regeneron's Trevogrumab Shows Promise in Preserving Muscle Mass When Combined with Wegovy in Weight-Loss Study

  • Regeneron's experimental drug trevogrumab, when combined with Novo Nordisk's Wegovy (semaglutide), helped preserve up to 80% of lean muscle mass compared to semaglutide alone in a mid-stage clinical study.
  • The combination therapy demonstrated enhanced fat loss while maintaining muscle mass, addressing a key concern in obesity treatment where muscle preservation is critical for metabolic health.
  • A triple combination including garetosmab showed substantially higher discontinuation rates due to tolerability issues, highlighting the importance of balancing efficacy with safety in combination therapies.
  • Full study results are expected later this year, which could provide crucial data for advancing this muscle-preserving approach to obesity treatment.

OnCusp's CDH6-Directed ADC CUSP06 Shows 36% Response Rate in Platinum-Resistant Ovarian Cancer

  • OnCusp Therapeutics reported initial Phase 1a results for CUSP06, a CDH6-directed antibody-drug conjugate, showing a 36% overall response rate in heavily pretreated platinum-resistant high-grade serous ovarian cancer patients.
  • The study enrolled 37 patients who received CUSP06 at doses ranging from 1.6 to 5.6 mg/kg every three weeks, with patients having a median of 4 prior lines of therapy.
  • CUSP06 demonstrated a manageable safety profile with hematologic toxicities as the most common treatment-related adverse events, and achieved a 92% clinical benefit rate in ovarian cancer patients.
  • The FDA recently granted Fast Track designation to CUSP06 for platinum-resistant ovarian cancer treatment, supporting its potential as a best-in-class therapy.

A Study of CUSP06 in Patients With Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors

2024-519862-33-00WithdrawnPhase 1
Oncusp Therapeutics Inc.

Kivu Bioscience Partners with Sterling Pharma for Phase 1 Manufacturing of Next-Generation ADC KIVU-107

Oncology
  • Kivu Bioscience has selected Sterling Pharma Solutions to manufacture cGMP clinical material for its lead oncology ADC candidate KIVU-107 ahead of Phase 1 trials.
  • KIVU-107 is described as a potential first-in-class antibody-drug conjugate featuring site-specific conjugation technology that positions the linker-payload in a natural antibody cavity.
  • The partnership leverages Sterling's dedicated bioconjugation facility in Deeside, UK, which recently received a £10 million investment to double its GMP manufacturing capacity.
  • The collaboration includes comprehensive development activities from process familiarization through analytical development and scale-up preparation for clinical manufacturing.

Newcastle University Researchers Identify Novel CD30-Targeting Combination Therapy to Overcome Immune Checkpoint Blockade Resistance in Melanoma

  • Newcastle University scientists led by Dr. Shoba Amarnath have discovered why over 60% of cancer patients fail to respond to immune checkpoint blockade therapy, identifying regulatory T cells as key drivers of resistance.
  • The research reveals that blocking PD-1 paradoxically enhances CD30 expression on regulatory T cells, promoting tumor growth and immune suppression in resistant patients.
  • A Phase II trial combining anti-PD1 therapy with Brentuximab Vedotin (anti-CD30) demonstrated 24% median survival benefit in patients with refractory metastatic cutaneous melanoma.
  • The findings, published in Nature Immunology, suggest this combination approach could benefit patients with lung, bowel, pancreatic and other solid cancers currently resistant to ICB monotherapy.

MiNK Therapeutics Secures NIAID Grant to Develop iNKT Cell Therapy for Graft-Versus-Host Disease Prevention

  • MiNK Therapeutics has been awarded a grant from the National Institute of Allergy and Infectious Diseases (NIAID) to advance its allogeneic iNKT cell therapy platform for preventing graft-versus-host disease following stem cell transplantation.
  • The collaboration with the University of Wisconsin aims to address the needs of nearly 50% of patients undergoing allogeneic stem cell transplants who are at risk for this serious and potentially life-threatening complication.
  • iNKT cells offer unique advantages in this setting due to their natural ability to regulate immune responses, promote tissue repair, and suppress inflammatory pathways while preserving infection-fighting capabilities.
  • The company's lead asset AGENT-797 is currently in clinical development for treating graft-versus-host disease, solid tumors, and critical pulmonary immune collapse.

Biocon Receives Indian Regulatory Approval for Generic Liraglutide, Expanding GLP-1 Diabetes Treatment Access

Drug Approval
  • Biocon Limited has received approval from India's CDSCO for its generic version of Victoza (liraglutide), marking the company's first vertically integrated GLP-1 diabetes therapy clearance in the country.
  • The approval covers both the drug substance and a 6 mg/ml solution for injection in pre-filled pens and cartridges, indicated for Type 2 diabetes treatment in adults, adolescents, and children aged 10 years and above.
  • With over 77 million people living with diabetes in India, this regulatory milestone addresses a critical unmet medical need and aligns with Biocon's mission to provide affordable access to lifesaving medications.
  • The company is preparing to launch the product through commercialization partners as part of its strategic focus on GLP-1 therapies as a future growth driver.

Regeneron Licenses Chinese GLP-1/GIP Dual Agonist in $2 Billion Obesity Deal with Hansoh Pharma

  • Regeneron acquired exclusive rights to HS-20094, a dual GLP-1/GIP receptor agonist from Hansoh Pharmaceuticals, for $80 million upfront and up to $1.93 billion in milestone payments.
  • The weekly subcutaneous injection has been studied in over 1,000 patients and demonstrates a potentially similar profile to the only FDA-approved GLP-1/GIP receptor agonist.
  • Regeneron plans to combine HS-20094 with its proprietary muscle-preserving antibodies to address muscle loss and obesity comorbidities.
  • The deal marks Regeneron's official entry into the GLP-1 space following recent setbacks with its Dupixent follow-up program.

XNW27011 Study of Advanced Solid Tumor Subjects Who Failed Standard Therapies.

NCT06792435RecruitingPhase 1
Evopoint Biosciences Inc.
Posted 7/27/2023

A Study of HS-20094 in Chinese Adults with Overweight or Obesity

NCT06839664RecruitingPhase 3
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Posted 11/11/2024

A Study of HS-20094 in Patients With T2DM

NCT06901648CompletedPhase 2
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Posted 2/6/2024

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