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BRIEF TITLE: Study of TPST-1120 as a Single Agent or in Combination With Systemic Anti-Cancer Therapies in Subjects With Advanced Solid Tumors

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


  • Org Study ID: TPST-1120-001
  • Secondary ID:
  • NCT ID: NCT03829436
  • NCT Alias:
  • Sponsor: Tempest Therapeutics - Industry
  • Source: Tempest Therapeutics

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 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.

Detailed Description


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 Outcomes:

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

Condition:

  • 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

Eligibility

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

Official Information

Name: Ginna Laport, MD

Role: Study Director

Affiliation: Tempest Therapeutics

Overall Contact

Name: Matthew Hauffe

Phone: (415) 354-5571

Email: mhauffe@tempesttx.com

Locations

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