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Recruiting NCT07403721

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AMG 436.
Who it may be relevant to
Registry conditions: Metastatic or Locally Advanced Solid Tumors With Microsatellite Instability-high (MSI-H) or Mismatched Repair Deficiency (dMMR). Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Belgium, Canada, China +5
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1/1b Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AMG 436 as Monotherapy and in Combination With Other Therapies in Participants With Microsatellite Instability-high (MSI-H)/Mismatch Repair Deficient (dMMR) Solid Tumors

Overview

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.

Interventions

  • Drug AMG 436
    AMG 436 will be administered.

Primary outcome measures

  • Number of Participants with a Dose Limiting Toxicity (DLT) [Time frame: Up to 21 days]
  • Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time frame: Up to 5 years]
Secondary outcome measures (12)
  • Maximum Serum Concentration (Cmax) of AMG 436 [Time frame: Up to 57 days]
  • Minimum Serum Concentration (Cmin) of AMG 436 [Time frame: Up to 57 days]
  • Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 436 [Time frame: Up to 57 days]
  • Time to Achieve Cmax (Tmax) of AMG 436 [Time frame: Up to 57 days]
  • Part 1B: Cmax of AMG 436 in the Fed and/or Fasted State [Time frame: Up to 24 days]
  • Part 1B: Tmax of AMG 436 in the Fed and/or Fasted State [Time frame: Up to 24 days]
  • Part 1B: AUC Over the Dosing Interval of AMG 436 in the Fed and/or Fasted State [Time frame: Up to 24 days]
  • Confirmed Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [Time frame: Up to 5 years]
  • Duration of Response (DOR) per RECIST v1.1 [Time frame: Up to 5 years]
  • Time to Response (TTR) per RECIST v1.1 [Time frame: Up to 5 years]
  • Disease Control Rate (DCR) per RECIST v1.1 [Time frame: Up to 5 years]
  • Progression-free Survival (PFS) per RECIST v1.1 [Time frame: Up to 5 years]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 6 centers
  • City of Hope Orange County Lennar Foundation Cancer Center — Irvine
  • Midwestern Regional Medical Center dba City of Hope Chicago — Zion
  • Community Health Network MD Anderson Cancer Center - North — Indianapolis
  • New England Cancer Specialists — Westbrook
  • Tennessee Oncology PLLC — Nashville
  • Next Oncology - Dallas — Irving
Japan · 4 centers
  • Aichi Cancer Center — Nagoya
  • National Cancer Center Hospital East — Kashiwa-shi
  • National Cancer Center Hospital — Chuo-ku
  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research — Koto-ku
Spain · 3 centers
  • Hospital Universitari Vall d Hebron — Barcelona
  • Hospital Clinic i Provincial de Barcelona — Barcelona
  • Clinica Universidad de Navarra — Madrid
Australia · 2 centers
  • Calvary Mater Newcastle Hospital — Waratah
  • Peter MacCallum Cancer Centre — Melbourne
Belgium · 2 centers
  • Universite Catholique de Louvain Cliniques Universitaires Saint Luc — Brussels
  • Universitair Ziekenhuis Gent — Ghent
China · 2 centers
  • Sun Yat-Sen University Cancer Center — Guangzhou
  • Zhongshan Hospital Fudan University — Shanghai
France · 2 centers
  • Hopital Saint Antoine — Paris
  • Gustave Roussy — Villejuif
Canada · 1 center
  • Princess Margaret Cancer Centre — Toronto
South Korea · 1 center
  • Asan Medical Center — Seoul
Taiwan · 1 center
  • Taipei Veterans General Hospital — Taipei

Identifiers

NCT: NCT07403721 · 20250004 · 2025-524056-63-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗