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Evaluating AMG 355 alone and with Pembrolizumab for 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

Phase 1 Interventional Amgen · NCT06131398

This study is testing a new treatment called AMG 355, both alone and with another drug called pembrolizumab, to see if it is safe and effective for people with advanced solid tumors that haven't responded to other treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment535 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorAmgen Industry-sponsored
Drugs / interventionspembrolizumab, prednisone
Locations25 sites (Duarte, California and 24 other locations)
Trial IDNCT06131398 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and tolerability of AMG 355, both as a standalone treatment and in combination with pembrolizumab, in patients with advanced solid tumors. It will determine the recommended phase 2 dose and the maximum tolerated dose for AMG 355 in these patients. Participants must have advanced solid tumors that have either relapsed or are refractory to existing therapies. The study will involve biopsies to evaluate the treatment's effectiveness.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed metastatic or locally advanced solid tumors that have not responded to or are ineligible for standard therapies.

Not a fit: Patients with early-stage tumors or those who have not yet received standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment choices.

How similar studies have performed: Other studies have shown promise with similar immunotherapy combinations, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key 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).

Note: Where slides are accepted, samples must consist of a minimum of 11 (21 preferred) freshly-cut, serially, sectioned, unstained slides. A formalin-fixed, paraffin embedded block is preferred if available, but in lieu of a block, unstained slides or fresh wet tissue is acceptable.

Key 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.

Other protocol-defined inclusion/exclusion criteria apply.

Where this trial is running

Duarte, California and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Solid TumorsAMG 355PembrolizumabPharmacokineticsNon-small Cell Lung CancerColorectal CancerGastric CancerMelanoma
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.