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Brief Title: TPST-1120 as Monotherapy and in Combination With (Nivolumab, Docetaxel or Cetuximab) 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

INTRODUCTION

  • Org Study ID: TPST-1120-001
  • Secondary ID: N/A
  • NTC ID: NCT03829436
  • Sponsor: 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 a systemic anticancer agent, nivolumab, an anti-PD1 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-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.

  • Overall Status
    Recruiting
  • Start Date
    March 20, 2019
  • Phase
    Phase 1
  • Study Type
    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.

Primary Outcome 1 - Timeframe: 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.

Primary Outcome 2 - Timeframe: From start of treatment to end of treatment, up to 36 months

Primary Outcome 3 - Measure: Identify the maximum tolerated dose

Primary Outcome 3 - Timeframe: 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

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Robert Stagg, PharmD

Role: Study Director

Affiliation: Tempest Therapeutics

Overall Contact

Name: Robert Stagg, PharmD

Phone: 415-798-8589

Email: 1120-Inquiries@tempesttx.com

LOCATION

Facility Status Contact
Facility: University of California - San Francisco
San Francisco, California 94158
United States
Status: Recruiting Contact: Contact
Melissa Lopez
786-527-8116 48171
Melissa.Lopez@ucsf.edu
Facility: Miami Cancer Institute
Miami, Florida 33176
United States
Status: Recruiting Contact: Contact
Bruno Bastos, MD
800-865-1125
MiamiCancerInstTrial@baptisthealth.net
Facility: Johns Hopkins University
Baltimore, Maryland 21287
United States
Status: Recruiting Contact: Contact
Mark Yarchoan, MD
212-342-5162
mark.yarchoan@jhmi.edu
Facility: University of Michigan Rogel Cancer Center
Ann Arbor, Michigan 48109
United States
Status: Recruiting Contact: Contact
Cancer AnswerLine
980-441-1021
CancerAnswerLine@med.umich.edu
Facility: Columbia University Medical Center
New York, New York 10024
United States
Status: Recruiting Contact: Contact
Lisa Olmos
405-271-8001
lo2345@cumc.columbia.edu
Facility: Carolina BioOncology Institute
Huntersville, North Carolina 28078
United States
Status: Recruiting Contact: Contact
Ashley McClain
215-662-7762
amcclain@carolinabiooncology.org
Facility: Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
Status: Recruiting Contact: Principal Investigator
John Powderly, MD
215-614-7677
erica.stair@pennmedicine.upenn.edu
Facility: University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania 19104
United States
Status: Recruiting Contact: Contact
Christina Caldwell, LPN
215-955-8874
philip.seger@pennmedicine.upenn.edu
Facility: Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States
Status: Recruiting Contact: Principal Investigator
Susanna Ulahannan, MD
412-623-7957
Kylie.Cavin@SarahCannon.com
Facility: UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15213
United States
Status: Recruiting Contact: Contact
Erica Stair

Facility: Sarah Cannon Research Institute - TN
Nashville, Tennessee 37203
United States
Status: Recruiting Contact: Contact
Philip Seger