Study Complete
Sponsor ID
20220028

A Study of AMG 355 Alone and in Combination with Pembrolizumab in Participants with Advanced Solid Tumors

Sponsor ID
20220028
Clinicaltrials.gov ID
NCT06131398
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The primary objectives of this study are to:

- Evaluate the safety and tolerability of AMG 355 as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors

- Determine the recommended phase 2 dose and the maximum tolerated dose for AMG 355 as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors.

Additional Study Details

Phase
Phase 1
Product
AMG 355
Type
Interventional
Masking
None (Open Label)
Enrollment
77
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Participants Who Experience a Dose Limiting Toxicity (DLT)

Timeframe: Day 1 to Day 21

Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)

Timeframe: Up to 2 years

Number of Participants Who Experience a Treatment-related AE

Timeframe: Up to 2 years

Secondary Outcome Measures

Maximum Observed Serum Concentration (Cmax) of AMG 355

Timeframe: Up to 85 days

Minimum Observed Serum Concentration (Cmin) of AMG 355

Timeframe: Up to 85 days

Area Under the Concentration-time Curve (AUC) of AMG 355

Timeframe: Up to 85 days

Confirmed Objective Response (OR) Based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

Timeframe: Up to 2 years

Clinical Benefit per RECIST v1.1

Timeframe: Up to 2 years

Duration of Response per RECIST v1.1

Timeframe: Up to 2 years

Time to Progression by RECIST v1.1

Timeframe: Up to 2 years

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

Timeframe: Up to 2 years

Overall Survival

Timeframe: Up to 2 years

Change From Baseline in C-C motif chemokine receptor 8 (CCR8+) Expression Between Pre and On Treatment Tumor Samples

Timeframe: Up to 2 years

Locations

Location
Status
Contact Us
Location
Alliance for Multispecialty Research - Kansas City
Merriam, KS, United States, 66204
Status
Completed
Location
City of Hope National Medical Center
Duarte, CA, United States, 91010
Status
Recruiting
Location
South Texas Accelerated Research Therapeutics
San Antonio, TX, United States, 78229
Status
Recruiting
Location
The Queen Elizabeth Hospital
Woodville South, SA, Australia, 5011
Status
Recruiting
Location
Asan Medical Center
Seoul, Republic of Korea, 138-736
Status
Recruiting
Location
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan, 277-8577
Status
Recruiting
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