Clinical trialNCT04682431TerminatedPhase 1Interventional

A Phase 1a/1b FIH Study of PY159 and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

SponsorIkena OncologyEnrollment127Advanced Solid TumorBreast CancerColorectal CancerGastric AdenocarcinomaGynecologic CancerHead and Neck Cancer+2 more conditions

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This is an open-label, multicenter, First-In-Human (FIH), Phase 1a/1b study of PY159 in subjects with locally advanced (unresectable) and/or metastatic solid tumors that are refractory or relapsed to Standard Of Care (including Checkpoint Inhibitors, if approved for that indication).

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Len Reyno, MD
Ikena Oncology
Study Director
clinicaltrials.gov ↗
Marc Chamberlain, MD
Ikena Oncology
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

17 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Usc Norris Cancer Center
Los Angeles, California, United States
Ucsf Mount Zion Cancer Center
San Francisco, California, United States
Ucla Parkside Cancer Center
Santa Monica, California, United States
University of Colorado
Aurora, Colorado, United States
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States
Florida Cancer Specialists - Sarasota - Scri
Sarasota, Florida, United States
Indiana University
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Case Western Reserve University
Cleveland, Ohio, United States
the University of Oklahoma
Norman, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Mary Crowley Cancer Center
Dallas, Texas, United States
the University of Texas Md Anderson Cancer Center
Houston, Texas, United States
Start South Texas Accelerated Research Therapeutic
San Antonio, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

PY159 Single agent dose expansion cohortPY159 Single agent dose level 1PY159 Single agent dose level 2PY159 Single agent dose level 3PY159 Single agent dose level 4PY159 Single agent dose level 5PY159 Single agent dose level 6PY159 Single agent dose level 7PY159/Pembrolizumab Combination dose expansion cohort 1PY159/Pembrolizumab Combination dose expansion cohort 2PY159/Pembrolizumab Combination dose expansion cohort 3PY159/Pembrolizumab Combination dose expansion cohort 4PY159/Pembrolizumab Combination dose expansion cohort 5PY159/Pembrolizumab Combination dose expansion cohort 6PY159/Pembrolizumab Combination dose level 1PY159/Pembrolizumab Combination dose level 2PY159/Pembrolizumab Combination dose level 3PY159/Pembrolizumab Combination dose level 4

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 10 Nov 2020
Primary completion: 25 Aug 2023
Completion: 31 Aug 2023
Last update posted: 22 Mar 2024
Registered enrollment: 127
Registry id: NCT04682431

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.