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Recruiting Phase 1

AMG 436 as Monotherapy and Combination Therapy in Participants With MSI-H/dMMR Solid Tumors

NCT07403721 · tracked via the Priya Life Science Spain tracker
Sponsor
Phase
Phase 1
Started
2026-04-08
Last updated
2026-09-21

Condition(s) studied

Metastatic or Locally Advanced Solid Tumors With Microsatellite Instability-high (MSI-H) or Mismatched Repair Deficiency (dMMR)

Investigational drug(s) / intervention(s)

AMG 436

AMG 436: AMG 436 will be administered.

Study summary

The primary objectives of this trial are to evaluate the safety profile of AMG 436 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for AMG 436 as monotherapy and in combination with other anti-cancer therapies in participants with MSI-H/dMMR solid tumors.

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years). * Histologically confirmed MSI-H or dMMR metastatic or locally advanced solid tumor by local testing or central testing. * Tumor tissue (formalin-fixed, paraffin-embedded sample) archival block must be available. Participants without archived tumor tissue may enroll by undergoing tumor biopsy before dosing. * Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). * Eastern Cooperative Oncology Group performance (ECOG) 0-1. * Adequate organ function as defined in the protocol. Exclusion Criteria: * Participants with primary central nervous system (CNS) tumors. * Impaired cardiac function or clinically significant cardiac disease. * Major surgery within 28 days of trial day 1. * Antitumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 21 days of first dose of trial treatment, unless anti-tumor therapy is a therapy with 5 times the half-life being shorter than 21 days (in this case, enrollment may be allowed with washout from prior therapy of \< 21 days. * Radiation therapy within 28 days of the first dose of trial treatment (or local or focal radiotherapy with palliative intent within 14 days of the first dose). * Gastrointestinal tract disease causing the inability to take per os (PO) medication, malabsorption syndrome, requirement for intravenous (IV) alimentation, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis).

Primary outcome measure(s)

  • Number of Participants with a Dose Limiting Toxicity (DLT) — Up to 21 days
  • Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — Up to 5 years

Trial sites (25)

FacilityCityRegionStatus
City of Hope Orange County Lennar Foundation Cancer Center Irvine California Recruiting
Hoag Memorial Hospital Presbyterian Newport Beach California Recruiting
Midwestern Regional Medical Center dba City of Hope Chicago Zion Illinois Recruiting
Community Health Network MD Anderson Cancer Center - North Indianapolis Indiana Recruiting
New England Cancer Specialists Westbrook Maine Recruiting
Tennessee Oncology PLLC Nashville Tennessee Recruiting
Next Oncology - Dallas Irving Texas Recruiting
Calvary Mater Newcastle Hospital Waratah New South Wales Recruiting
Peter MacCallum Cancer Centre Melbourne Victoria Recruiting
Universite Catholique de Louvain Cliniques Universitaires Saint Luc Brussels Belgium Recruiting
Universitair Ziekenhuis Gent Ghent Belgium Recruiting
Princess Margaret Cancer Centre Toronto Ontario Recruiting
Sun Yat-Sen University Cancer Center Guangzhou Guangdong Recruiting
Zhongshan Hospital Fudan University Shanghai Shanghai Municipality Recruiting
Hopital Saint Antoine Paris France Recruiting
Gustave Roussy Villejuif France Recruiting
Aichi Cancer Center Nagoya Aichi-ken Recruiting
National Cancer Center Hospital East Kashiwa-shi Chiba Recruiting
National Cancer Center Hospital Chuo-ku Tokyo Recruiting
The Cancer Institute Hospital of Japanese Foundation for Cancer Research Koto-ku Tokyo Recruiting
Asan Medical Center Seoul South Korea Recruiting
Hospital Universitari Vall d Hebron Barcelona Catalonia Recruiting
Hospital Clinic i Provincial de Barcelona Barcelona Catalonia Recruiting
Clinica Universidad de Navarra Madrid Spain Recruiting
Taipei Veterans General Hospital Taipei Taiwan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07403721 on ClinicalTrials.gov ↗ ← All trials in Spain