Recruiting
Sponsor ID
20240031

AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors

Sponsor ID
20240031
Clinicaltrials.gov ID
NCT07094113
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The purpose of this first-in-human study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of AMG 410 when administered alone or in combination with other agents in participants with advanced or metastatic solid tumors harboring KRAS alterations.

This is a dose-escalation study in which participants will be assigned to multiple dose levels (DLs) of AMG 410, either as monotherapy or in combination with other agents, followed by expansion cohorts. The goal is to determine the Maximum Tolerated Dose (MTD)—the highest dose with acceptable safety and manageable side effects—or the Recommended Phase 2 Dose (RP2D) of AMG 410 in adult participants with KRAS-altered advanced or metastatic solid tumors.

Additional Study Details

Phase
Phase 1
Product
AMG 410
Type
Interventional
Masking
None (Open Label)
Enrollment
434
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Participants with Dose Limiting Toxicities (DLTs)

Timeframe: Up to 28 days

Number of Participants with Treatment Emergent Adverse Events (TEAEs)

Timeframe: Up to approximately 3 years

Number of Participants with Serious Adverse Events (SAEs)

Timeframe: Up to approximately 3 years

Secondary Outcome Measures

Maximum Concentration (Cmax) of AMG 410

Timeframe: Up to 85 days

Time to Reach Cmax (Tmax) of AMG 410

Timeframe: Up to 85 days

Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 410

Timeframe: Up to 85 days

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

Timeframe: Up to approximately 3 years

Clinical Benefit per RECIST v1.1

Timeframe: Up to approximately 3 years

Duration of Response (DoR) per RECIST v1.1

Timeframe: Up to approximately 3 years

Time to Response (TTR) per RECIST v1.1

Timeframe: Up to approximately 3 years

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

Timeframe: Up to approximately 3 years

Overall Survival (OS)

Timeframe: Up to approximately 3 years

Food Effect Substudy Cohort: Cmax of AMG 410 in the Fed and/or Fasted State

Timeframe: Up to 24 days

Food Effect Substudy Cohort: Tmax of AMG 410 in the Fed and/or Fasted State

Timeframe: Up to 24 days

Food Effect Substudy Cohort: AUC Over the Dosing Interval of AMG 410 in the Fed and/or Fasted State

Timeframe: Up to 24 days

Change From Baseline in Tumor Phosphorylated Extracellular Signal Regulated Kinase (pERK)

Timeframe: Baseline up to approximately 3 years

Locations

Location
Status
Contact Us
Location
Next Oncology
San Antonio, TX, United States, 78229
Status
Recruiting
Location
Next Virginia
Fairfax, VA, United States, 22031
Status
Recruiting
Location
Peter MacCallum Cancer Centre
Melbourne, VIC, Australia, 3000
Status
Recruiting
Location
City of Hope National Medical Center
Duarte, CA, United States, 91010
Status
Recruiting
Location
The Queen Elizabeth Hospital
Woodville South, SA, Australia, 5011
Status
Recruiting
Location
Princess Margaret Cancer Centre
Toronto, ON, Canada, M5G 1Z5
Status
Recruiting
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