A Phase 1a/1b FIH Study of PY159 and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Public ClinicalTrials.gov record NCT04682431. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1a/1b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PY159 as a Single Agent and In Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT04682431
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 127 participants
Conditions and interventions
Conditions
Interventions
- PY159 Single agent dose level 1 Drug
- PY159 Single agent dose level 2 Drug
- PY159 Single agent dose level 3 Drug
- PY159 Single agent dose level 4 Drug
- PY159 Single agent dose level 5 Drug
- PY159 Single agent dose level 6 Drug
- PY159 Single agent dose level 7 Drug
- PY159/Pembrolizumab Combination dose level 1 Drug
- PY159/Pembrolizumab Combination dose level 2 Drug
- PY159/Pembrolizumab Combination dose level 3 Drug
- PY159/Pembrolizumab Combination dose level 4 Drug
- PY159 Single agent dose expansion cohort Drug
- PY159/Pembrolizumab Combination dose expansion cohort 1 Drug
- PY159/Pembrolizumab Combination dose expansion cohort 2 Drug
- PY159/Pembrolizumab Combination dose expansion cohort 3 Drug
- PY159/Pembrolizumab Combination dose expansion cohort 4 Drug
- PY159/Pembrolizumab Combination dose expansion cohort 5 Drug
- PY159/Pembrolizumab Combination dose expansion cohort 6 Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 10, 2020 (Actual)
- Primary completion
- Aug 25, 2023 (Actual)
- Completion
- Aug 31, 2023 (Actual)
- Last update posted
- Mar 22, 2024
2020 – 2023
United States locations
- U.S. sites
- 17
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| USC Norris Cancer Center | Los Angeles | California | 90089 | — |
| UCSF Mount Zion Cancer Center | San Francisco | California | 94115 | — |
| UCLA Parkside Cancer Center | Santa Monica | California | 90404 | — |
| University of Colorado | Aurora | Colorado | 80045 | — |
| Smilow Cancer Hospital at Yale New Haven | New Haven | Connecticut | 06511 | — |
| Florida Cancer Specialists - Sarasota - SCRI | Sarasota | Florida | 34232 | — |
| Indiana University | Indianapolis | Indiana | 46202-5116 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | — |
| Case Western Reserve University | Cleveland | Ohio | 44106 | — |
| The University of Oklahoma | Norman | Oklahoma | 73019 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Mary Crowley Cancer Center | Dallas | Texas | 75230 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Start South Texas Accelerated Research Therapeutic | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04682431, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 22, 2024 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04682431 live on ClinicalTrials.gov.