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 other systemic anticancer agents including nivolumab, an anti-PD1 antibody, docetaxel, a cytotoxic chemotherapeutic agent and cetuximab, an anti-EGFR 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 will be
administered as monotherapy and in combination with standard of care systemic anticancer
agents including nivolumab, an anti-PD1 antibody, docetaxel, a cytotoxic chemotherapeutic
agent and cetuximab, an anti-EGFR antibody in subjects with advanced solid tumors. This trial
is composed of dose escalation and dose expansion cohorts.
| Overal Status | Start Date | Phase | Study Type |
|---|---|---|---|
| Recruiting | March 20, 2019 | Phase 1 | Interventional |
Primary Outcome 1 - Measure: Incidence of dose limiting toxicities (DLTs) of TPST-1120 as a single agent and in combination with nivolumab, in combination with docetaxel and in combination with cetuximab.
Primary Outcome 1 - Time Frame: From start of treatment to end of treatment, up to 36 months
Primary Outcome 2 - Measure: 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, in combination with docetaxel and in combination with cetuximab.
Primary Outcome 2 - Time Frame: From start of treatment to end of treatment, up to 36 months
Primary Outcome 3 - Measure: Identify the maximum tolerated dose
Primary Outcome 3 - Time Frame: From start of treatment to end of treatment, up to 36 months
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
- Must be willing to consent and undergo tumor biopsies
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)
- Any unresolved immune related adverse event > 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
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Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Ginna Laport, MD
Role: Study Director
Affiliation: Tempest Therapeutics
Name: Matthew Hauffe
Phone: (415) 354-5571
Email: mhauffe@tempesttx.com
| Facility | Status | Contact |
|---|---|---|
| Carolina BioOncology Institute Huntersville, North Carolina 28078 United States |
Recruiting |
Ashley McClain 980-441-1021 amcclain@carolinabiooncology.org |
| Sarah Cannon Research Institute - TN Nashville, Tennessee 37203 United States |
Recruiting |
Saurin Chokshi, MD 615-329-7274 Saurin.Chokshi@SarahCannon.com |
| Mary Crowley Cancer Research Dallas, Texas 75230 United States |
Recruiting |
Referral Team 972-566-3000 referral@marycrowley.org |
