Status:
COMPLETED
TPST-1120 as Monotherapy and in Combination With Nivolumab in Subjects With Advanced Cancers
Lead Sponsor:
Tempest Therapeutics
Conditions:
Hepatocellular Carcinoma
Metastatic Castration Resistant Prostate Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a phase 1/1b open label, multicenter dose escalation and dose expansion study to investigate the safety, tolerability and anti-tumor activity of TPST-1120, a small molecule selective antagonis...
Detailed Description
This is a phase 1/1b open label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary antitumor activity of TPST-1120, a sm...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Eastern Cooperative Oncology Group performance status of 0-1 at enrollment
- Progressive disease or previously untreated tumors for which no standard therapy exists or treatment naïve at the time of study entry are eligible
- Have at least one measurable lesion according to RECIST v1.1
- Subjects with the following histologies are eligible and who are refractory to, have failed, are intolerant to, are ineligible for standard therapy, or for which no standard therapy exists are eligible: Part 1 (Dose Escalation- Monotherapy): RCC, NSCLC, CRC, metastatic castration resistant prostate cancer (mCRPC), cholangiocarcinoma, TNBC, pancreatic cancer, HCC, gastroesophageal cancer, squamous cell carcinoma of head and neck (SCCHN), urothelial bladder cancer (UBC), and sarcoma (liposarcomas and leiomyosarcomas); Part 2 (Dose Escalation-Combination with nivolumab): RCC, HCC, and cholangiocarcinoma; Part 3 (Dose Expansion-Monotherapy): RCC, HCC and cholangiocarcinoma; Part 4 (Dose Expansion-Combination with nivolumab): HCC.
- Exclusion Criteria
- Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study, a specimen-collection study or the follow-up period of an interventional study
- Any chemotherapy, monoclonal antibody therapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment within 28 days of commencing TPST-1120 treatment. Targeted therapy such as tyrosine kinase inhibitors within 14 days of commencing first dose of study drug(s)
- For subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA4 therapy:
- Subjects must not have experienced an irAE toxicity that led to permanent discontinuation of prior immunotherapy.
- Any unresolved irAE \> Grade 1 with prior immunotherapy treatment.
- Symptomatic, untreated or actively progressing central nervous system metastases
- Have received fibrates within 28 days before first dose of investigational agent
Exclusion
Key Trial Info
Start Date :
March 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2022
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03829436
Start Date
March 20 2019
End Date
September 7 2022
Last Update
July 3 2023
Active Locations (11)
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1
University of California - San Francisco
San Francisco, California, United States, 94158
2
Miami Cancer Institute
Miami, Florida, United States, 33176
3
Johns Hopkins University
Baltimore, Maryland, United States, 21287
4
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109