CompletedPhase 1NCT03829436

TPST-1120 as Monotherapy and in Combination With Nivolumab in Subjects With Advanced Cancers

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.

Checked against the public recordLast updated Jul 3, 2023 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations11
SponsorTempest Therapeutics
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Tempest Therapeutics
Interventions being studied
Drug: Part 1 TPST-1120; Drug: Part 2 TPST-1120 + nivolumab; Drug: Part 3 TPST-1120; Drug: Part 4 TPST-1120 + nivolumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of California - San FranciscoSan Francisco, California
  • Miami Cancer InstituteMiami, Florida
  • Johns Hopkins UniversityBaltimore, Maryland
  • University of Michigan Rogel Cancer CenterAnn Arbor, Michigan
  • Columbia University Medical CenterNew York, New York
  • Carolina BioOncology InstituteHuntersville, North Carolina
  • Stephenson Cancer CenterOklahoma City, Oklahoma
  • University of Pennsylvania Perelman School of MedicinePhiladelphia, Pennsylvania
  • Thomas Jefferson University HospitalPhiladelphia, Pennsylvania
  • UPMC Hillman Cancer CenterPittsburgh, Pennsylvania
  • Sarah Cannon Research Institute - TNNashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 3, 2023. Always confirm current availability with the study team.

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