Education and Training

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

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.

Stanford is currently not accepting patients for this trial.

Intervention(s):

  • drug: Part 1 TPST-1120
  • drug: Part 2 TPST-1120 + nivolumab
  • drug: Part 3 TPST-1120
  • drug: Part 4 TPST-1120 + nivolumab

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:

      1. Subjects must not have experienced an irAE toxicity that led to permanent
      discontinuation of prior immunotherapy.

      2. 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Flordeliza Mendoza
650-724-2056
Not Recruiting