Recruiting
Sponsor ID
20250004

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

Sponsor ID
20250004
Clinicaltrials.gov ID
NCT07403721
EUCTIS ID
2025-524056-63-00
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1
Product
AMG 436
Type
Interventional
Masking
None (Open Label)
Enrollment
464
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Participants with a Dose Limiting Toxicity (DLT)

Timeframe: Up to 21 days

Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Timeframe: Up to 5 years

Secondary Outcome Measures

Maximum Serum Concentration (Cmax) of AMG 436

Timeframe: Up to 57 days

Minimum Serum Concentration (Cmin) of AMG 436

Timeframe: Up to 57 days

Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 436

Timeframe: Up to 57 days

Time to Achieve Cmax (Tmax) of AMG 436

Timeframe: Up to 57 days

Part 1B: Cmax of AMG 436 in the Fed and/or Fasted State

Timeframe: Up to 24 days

Part 1B: Tmax of AMG 436 in the Fed and/or Fasted State

Timeframe: Up to 24 days

Part 1B: AUC Over the Dosing Interval of AMG 436 in the Fed and/or Fasted State

Timeframe: Up to 24 days

Confirmed Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Timeframe: Up to 5 years

Duration of Response (DOR) per RECIST v1.1

Timeframe: Up to 5 years

Time to Response (TTR) per RECIST v1.1

Timeframe: Up to 5 years

Disease Control Rate (DCR) per RECIST v1.1

Timeframe: Up to 5 years

Progression-free Survival (PFS) per RECIST v1.1

Timeframe: Up to 5 years

Overall Survival (OS) per RECIST v1.1

Timeframe: Up to 5 years

Change From Baseline in Tumor Phosphorylated Checkpoint Kinase 2 (CHK2) Following AMG 436

Timeframe: Baseline up to 5 years

Locations

Location
Status
Contact Us
Location
Next Oncology - Dallas
Irving, TX, United States, 75039
Status
Recruiting
Location
Aichi Cancer Center
Nagoya-shi, Aichi, Japan, 464-8681
Status
Recruiting
Location
Zhongshan Hospital Fudan University
Shanghai, Shanghai, China, 200032
Status
Recruiting
Location
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Status
Recruiting
Location
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, Japan, 135-8550
Status
Recruiting
Location
Peter MacCallum Cancer Centre
Melbourne, VIC, Australia, 3000
Status
Recruiting
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