This study is in progress, not accepting new patients

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

a study on Hepatocellular Cancer Hepatocellular Carcinoma Liver Cancer Metastatic Castration-Resistant Prostate Cancer Prostate Cancer Kidney Cancer Renal Cell Carcinoma Lung Cancer Non-Small Cell Lung Cancer Colorectal Cancer Head and Neck Cancer Head and Neck Squamous Cell Carcinoma Squamous Cell Carcinoma Breast Cancer Triple-Negative Breast Cancer Transitional Cell Carcinoma Cholangiocarcinoma Esophageal Cancer Pancreatic Cancer Sarcoma Solid Tumor Carcinoma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Pamela Munster
Headshot of Pamela Munster
Pamela Munster

Description

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 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

Details

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 small molecule selective antagonist of PPARα (peroxisome proliferator activated receptor alpha) in adult subjects with selected advanced solid tumors. TPST-1120 will be administered as monotherapy and in combination with a systemic anticancer agent, nivolumab, an anti-PD1 antibody, in subjects with advanced solid tumors. This trial is composed of dose escalation and dose expansion cohorts.

Keywords

Hepatocellular Carcinoma, Metastatic Castration Resistant Prostate Cancer, Renal Cell Carcinoma, Non-small Cell Lung Cancer, Colorectal Cancer, Squamous Cell Carcinoma of Head and Neck, Triple-Negative Breast Cancer, Urothelial Carcinoma, Cholangiocarcinoma, GastroEsophageal Cancer, Pancreatic Cancer, Sarcoma, Carcinoma, Triple Negative Breast Neoplasms, Nivolumab, Part 1 TPST-1120, Part 2 TPST-1120 + nivolumab, Part 3 TPST-1120, Part 4 TPST-1120 + nivolumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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

Locations

  • UCSF
    San Francisco California 94158 United States
  • Stephenson Cancer Center
    Oklahoma City Oklahoma 73104 United States

Lead Scientist at UCSF

  • Pamela Munster
    Professor, Medicine, School of Medicine. Authored (or co-authored) 142 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Tempest Therapeutics
ID
NCT03829436
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 138 study participants
Last Updated