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

A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 355 as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

NCT06131398•Amgen

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 18 years at the time of signing informed consent.
•Participants with histologically or cytologically confirmed metastatic or locally advanced solid tumors who have relapsed after and/or are refractory to or ineligible for established and available therapies with known clinical benefit at time of pre-screening:
•* Group A: NSCLC, CRC, GC, and melanoma.
•* Group B: NSCLC, CRC, GC.
•Eastern Cooperative Oncology Group Performance status 0 or 1.
•Life expectancy of \> 3 months, in the opinion of the investigator.
•At least 1 measurable lesion as defined by modified RECIST 1.1 guidelines. Note: this lesion should be avoided for the required biopsies on the study.
•Participants must be willing to undergo 1 or more biopsies as follows:
•* Fresh biopsy prior to enrollment is preferred or, if fresh tissue is not obtainable, an archival tumor sample may be acceptable if the sample was obtained within 6 months of enrollment and participant has not received any other treatment since sample was obtained, consult the Medical Monitor.
•* Mandatory fresh biopsy during cycle 2 (before the restaging of CT-scan) of treatment with AMG 355 (± pembrolizumab).
+1 more criteria

Exclusion Criteria

•Participant who received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX 40, CD137), and was discontinued from that treatment due to an immune-related adverse events.
•Untreated or symptomatic brain metastases and leptomeningeal disease Note: participants with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
•Chronic intake of systemic corticosteroids (eg prednisone \> 10 mg/day or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
•Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine or insulin) is not considered a form of systemic treatment and is allowed.
•History of organ transplantation.
•History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
•History of any immune-related colitis. Infectious colitis is allowed if evidence of adequate treatment and clinical recovery exists and at least 3 months interval observed since diagnosis of colitis.

Locations (25)

City of Hope National Medical Center

Duarte, California, United States

Alliance for Multispecialty Research - Kansas City

Merriam, Kansas, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Washington University

St Louis, Missouri, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

South Texas Accelerated Research Therapeutics

San Antonio, Texas, United States

St Vincents Hospital Sydney

Darlinghurst, New South Wales, Australia

The Queen Elizabeth Hospital

Woodville South, South Australia, Australia

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Institut Bergonie

Bordeaux, France

Key Dates

Start Date

March 7, 2024

Primary Completion Date

May 24, 2026

Completion Date

August 3, 2026

Last Updated

December 22, 2025

Enrollment

ACTUAL participants

Conditions

Advanced Solid Tumors

Interventions

AMG 355

DRUG

Pembrolizumab

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

A Study of ASP1002 in Adults for Treatment of Solid Tumors

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