Completed PHASE1 INTERVENTIONAL 5-arm NCT04344795

Phase 1a/1b Study of TPST-1495 as a Single Agent and in Combination With Pembrolizumab in Subjects With Solid Tumors

Phase 1a/1b Open Label Dose-escalation and Expansion Study of TPST-1495 as a Single Agent and in Combination With Pembrolizumab in Subjects With Solid Tumors

Sponsor: Tempest Therapeutics

Conditions Colorectal Cancer Endometrial Cancer Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Non Small Cell Lung Cancer Solid Tumor Solid Tumors With PIK3Ca Mutation Squamous Cell Carcinoma of Head and Neck Urothelial Carcinoma

Interventions Pembrolizumab TPST-1495 once daily or on intermittent schedule TPST-1495 twice daily

Updated 17 times since 2020 Last updated: Sep 5, 2025 Started: May 6, 2020 Primary completion: Sep 25, 2024 Completion: Sep 25, 2024

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Colorectal Cancer and Endometrial Cancer and is currently completed. Tempest Therapeutics leads this study, which shows 17 recorded versions since 2020 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

Change History

17 versions recorded

Oct 2025 — Present [monthly]

Completed PHASE1

Status: Active Not Recruiting → Completed
Nov 2024 — Oct 2025 [monthly]

Active Not Recruiting PHASE1
Sep 2024 — Nov 2024 [monthly]

Active Not Recruiting PHASE1
Jul 2024 — Sep 2024 [monthly]

Active Not Recruiting PHASE1
May 2024 — Jul 2024 [monthly]

Active Not Recruiting PHASE1

Status: Recruiting → Active Not Recruiting

▶ Show 12 earlier versions

Nov 2023 — May 2024 [monthly]

Recruiting PHASE1
Oct 2023 — Nov 2023 [monthly]

Recruiting PHASE1
Jul 2023 — Oct 2023 [monthly]

Recruiting PHASE1
Feb 2023 — Jul 2023 [monthly]

Recruiting PHASE1
Apr 2022 — Feb 2023 [monthly]

Recruiting PHASE1
Feb 2022 — Apr 2022 [monthly]

Recruiting PHASE1
Nov 2021 — Feb 2022 [monthly]

Recruiting PHASE1
May 2021 — Nov 2021 [monthly]

Recruiting PHASE1
Apr 2021 — May 2021 [monthly]

Recruiting PHASE1
Jan 2021 — Apr 2021 [monthly]

Recruiting PHASE1
Jun 2020 — Jan 2021 [monthly]

Recruiting PHASE1
May 2020 — Jun 2020 [monthly]

Recruiting PHASE1

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Tempest Therapeutics

Data source: Tempest Therapeutics

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Ann Arbor, United States , Aurora, United States , Baltimore, United States , Grand Rapids, United States , Huntersville, United States , Nashville, United States , Oklahoma City, United States , Philadelphia, United States , Pittsburgh, United States , San Antonio, United States and 1 more location