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
1 other identifier
interventional
38
1 country
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 hepatocellular-carcinoma
Started Mar 2019
Typical duration for phase_1 hepatocellular-carcinoma
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2019
CompletedFirst Posted
Study publicly available on registry
February 4, 2019
CompletedStudy Start
First participant enrolled
March 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 7, 2022
CompletedJuly 3, 2023
June 1, 2023
3.5 years
January 30, 2019
June 28, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Incidence of dose limiting toxicities (DLTs) of TPST-1120 as a single agent and in combination with nivolumab.
Incidence of dose limiting toxicities (DLTs) of TPST-1120 as a single agent and in combination with nivolumab.
From start of treatment to end of treatment, up to 36 months
Incidence of treatment-emergent adverse events as assessed by NCI-CTCAE v5.0 of TPST-1120 as a single agent and in combination with nivolumab.
Incidence of treatment-emergent adverse events as assessed by NCI-CTCAE v5.0 of TPST-1120 as a single agent and in combination with nivolumab.
From start of treatment to end of treatment, up to 36 months
Identify the maximum tolerated dose
Incidence of dose limiting toxicities (DLTs) of TPST-1120 as a single agent and in combination with nivolumab.
From start of treatment to end of treatment, up to 36 months
Secondary Outcomes (3)
Assess pharmacokinetics: Maximum serum concentration (Cmax)
Day 1, 2, 8 of Cycle 1 and Day 1 of Cycle 3 (cycle can be 21 or 28 days, depending on cohort assignment)
Assess pharmacokinetics: Area under the curve (AUC)
Day 1, 2, 8 of Cycle 1 and Day 1 of Cycle 3, Day 1 of Cycles 5+ (cycle can be 21 or 28 days, depending on cohort assignment)
Objective response rate
From start of treatment to end of treatment, up to 36 months
Study Arms (4)
Part 1 TPST-1120
EXPERIMENTALSubjects 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
EXPERIMENTALSubjects 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
EXPERIMENTALSelected dose of TPST-1120 administered orally twice daily until disease progression
Part 4 TPST-1120 + nivolumab
EXPERIMENTALSelected 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
Interventions
Subjects will receive escalating doses of TPST-1120 administered orally twice daily continuously until MTD is reached or until disease progression
Subjects will receive escalating doses of TPST-1120 administered orally twice daily
Selected dose of TPST-1120 administered orally twice daily until disease progression
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
Eligibility Criteria
You may qualify if:
- 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 may not qualify 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:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
University of California - San Francisco
San Francisco, California, 94158, United States
Miami Cancer Institute
Miami, Florida, 33176, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
Columbia University Medical Center
New York, New York, 10024, United States
Carolina BioOncology Institute
Huntersville, North Carolina, 28078, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15213, United States
Sarah Cannon Research Institute - TN
Nashville, Tennessee, 37203, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robert Stagg, PharmD
Tempest Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2019
First Posted
February 4, 2019
Study Start
March 20, 2019
Primary Completion
September 7, 2022
Study Completion
September 7, 2022
Last Updated
July 3, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share