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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• AMG 436 — DRUG
  AMG 436 will be administered.

Study Details

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.

Key Dates

Start date

Apr 8, 2026

Status verified

Jun 2026

Primary completion

Jun 28, 2028

Completion

Jun 28, 2028

Study Design

Enrollment

464 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1A
  AMG 436 monotherapy dose escalation.
• Experimental: Part 1B: Food Effect Substudy
  Participants will receive AMG 436 under fasted and fed conditions (United States only).
• Experimental: Part 2
  AMG 436 + combination dose escalation.
• Experimental: Part 3
  AMG 436 monotherapy Dose expansion and optimization.
• Experimental: Part 4
  AMG 436 + chemotherapy combination dose expansions.

Primary Outcome Measure

Number of Participants with a Dose Limiting Toxicity (DLT) [ Time Frame: Up to 21 days ]

Central Contacts

• Amgen Call Center
  866-572-6436
  [email protected]

Locations (5)

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