Trial | NCT03829436  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    38
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.
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.
Study Started
Mar 20
2019
Primary Completion
Sep 07
2022
Study Completion
Sep 07
2022
Last Update
Jul 03
2023

Drug Part 1 TPST-1120

Subjects will receive escalating doses of TPST-1120 administered orally twice daily continuously until MTD is reached or until disease progression

  • Other names: Experimental

Drug Part 2 TPST-1120 + nivolumab

Subjects will receive escalating doses of TPST-1120 administered orally twice daily

  • Other names: Experimental + Opdivo

Drug Part 3 TPST-1120

Selected dose of TPST-1120 administered orally twice daily until disease progression

  • Other names: Experimental

Drug Part 4 TPST-1120 + nivolumab

Selected dose of TPST-1120 administered orally twice daily in combination with nivolumab administered intravenously every 28 days until MTD is reached for TPST-1120 or until disease progression

  • Other names: Experimental + Opdivo

Part 1 TPST-1120 Experimental

Subjects will receive escalating doses of TPST-1120 administered orally twice daily continuously until MTD is reached or until disease progression

Part 2 TPST-1120 + nivolumab Experimental

Subjects will receive escalating doses of TPST-1120 administered orally twice daily in combination with nivolumab administered intravenously every 28 days until MTD is reached for TPST-1120 or until disease progression.

Part 3 TPST-1120 Experimental

Selected dose of TPST-1120 administered orally twice daily until disease progression

Part 4 TPST-1120 + nivolumab Experimental

Selected dose of TPST-1120 administered orally twice daily in combination with nivolumab administered intravenously every 28 days until MTD is reached for TPST-1120 or until disease progression

Criteria 

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
No Results Posted