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Phase 1/1b TPST-1120 Single Agent or Combo w/ Systemic Anti-Cancer Therapies in Advanced SolidTumors
Not Recruiting
Trial ID: NCT03829436
Purpose
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 antagonist of PPARα (peroxisome proliferator activated receptor alpha) as monotherapy and in combination with a systemic anticancer agent, nivolumab, an anti-PD1 antibody, in subjects with advanced solid tumors.
Official Title
A Phase 1/1b Open-label, Dose-escalation and Dose-expansion Study of TPST-1120 as a Single Agent or in Combination With Systemic Anti-Cancer Therapies in Subjects With Advanced Solid Tumors
Stanford Investigator(s)
Gregory Marshal Heestand
Clinical Associate Professor, Medicine - Oncology
Eligibility
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:
1. Subjects must not have experienced an irAE toxicity that led to permanent discontinuation of prior immunotherapy.
2. 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
Intervention(s):
drug: Part 1 TPST-1120
drug: Part 2 TPST-1120 + nivolumab
drug: Part 3 TPST-1120
drug: Part 4 TPST-1120 + nivolumab
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Flordeliza Mendoza
650-724-2056