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

Part of paid clinical trials in San Francisco, California.

Sponsor
Tempest Therapeutics
Study ID
NCT03829436
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Part 1 TPST-1120 — DRUG
    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 — DRUG
    Subjects will receive escalating doses of TPST-1120 administered orally twice daily
  • Part 3 TPST-1120 — DRUG
    Selected dose of TPST-1120 administered orally twice daily until disease progression
  • Part 4 TPST-1120 + nivolumab — DRUG
    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

Study Details

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.

Key Dates

Start date
Mar 20, 2019
Status verified
Jun 2023
Primary completion
Sep 7, 2022
Completion
Sep 7, 2022

Study Design

Enrollment
38 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Experimental: Part 2 TPST-1120 + nivolumab
    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.
  • Experimental: Part 3 TPST-1120
    Selected dose of TPST-1120 administered orally twice daily until disease progression
  • Experimental: 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

Primary Outcome Measure

Incidence of dose limiting toxicities (DLTs) of TPST-1120 as a single agent and in combination with nivolumab. [ Time Frame: From start of treatment to end of treatment, up to 36 months ]

Locations (11)

FacilityCityStateZIPSite coordinators
University of California - San FranciscoSan FranciscoCalifornia94158-
Miami Cancer InstituteMiamiFlorida33176-
Johns Hopkins UniversityBaltimoreMaryland21287-
University of Michigan Rogel Cancer CenterAnn ArborMichigan48109-
Columbia University Medical CenterNew YorkNew York10024-
Carolina BioOncology InstituteHuntersvilleNorth Carolina28078-
Stephenson Cancer CenterOklahoma CityOklahoma73104-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
University of Pennsylvania Perelman School of MedicinePhiladelphiaPennsylvania19104-
UPMC Hillman Cancer CenterPittsburghPennsylvania15213-
Sarah Cannon Research Institute - TNNashvilleTennessee37203-

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University of California - San Francisco· San Francisco, CAMiami Cancer Institute· Miami, FLJohns Hopkins University· Baltimore, MDUniversity of Michigan Rogel Cancer Center· Ann Arbor, MIColumbia University Medical Center· New York, NYCarolina BioOncology Institute· Huntersville, NC

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