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

  • STATUS
    Recruiting
  • End date
    Jun 23, 2024
  • participants needed
    138
  • sponsor
    Tempest Therapeutics
Updated on 2 February 2021
cancer
measurable disease
carcinoma
small molecule
squamous cell carcinoma
progressive disease
nivolumab
solid tumour
squamous cell carcinoma of head and neck
bladder cancer
sarcoma
cholangiocarcinoma
head and neck carcinoma
liposarcoma
leiomyosarcoma

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 PPAR (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.

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 PPAR (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.

Details
Condition Pancreatic Cancer, Non-Small Cell Lung Cancer, Adenocarcinoma, Colorectal Cancer, Connective and Soft Tissue Neoplasm, Cholangiocarcinoma, Malignant neoplasm of kidney, Rectal disorder, Pancreatic disorder, Breast Cancer, Squamous cell carcinoma, Transitional cell carcinoma, Renal Cell Carcinoma, HEPATIC NEOPLASM, Neoplasm of unspecified nature of digestive system, Sarcoma, HEPATOCELLULAR CARCINOMA, head and neck cancer, Diet and Nutrition, Chronic Diarrhea, Pancreatic Disorders, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, All Solid Tumors, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Colon Cancer Screening, Rectal Disorders, Solid Tumors, Colon cancer; rectal cancer, Squamous Cell Carcinoma of the Head and Neck, Peripheral Arterial Occlusive Disease, Triple Negative Breast Cancer, Brain Function, Gastroesophageal Cancer, Squamous Cell Carcinoma of Head and Neck, Recurrent Respiratory Papillomatosis, Metastatic Castration Resistant Prostate Cancer, Razor Bumps (Pseudofolliculitis Barbae), Sarcoma (Pediatric), Islet Ce417ll Cancer, Metastatic Triple-Negative Breast Cancer, Kidney Cancer, Liver Cancer, Malignant Adenoma, Renal Cell Cancer, Renal Cancer, Digestive System Neoplasms, Soft Tissue Sarcoma, Urothelial Carcinoma, clear cell renal cell carcinoma, colorectal neoplasm, sarcomas, soft tissue sarcomas, colorectal cancers, nsclc, cancer of the pancreas, pancreatic cancers, cancer, pancreatic, liver cell carcinoma, cancer, colorectal, colorectal tumor, tumors, colorectal
Treatment Part 1 TPST-1120, Part 2a TPST-1120 + nivolumab, Part 2b TPST-1120 + docetaxel, Part 2c TPST-1120 + cetuximab, Part 3 TPST-1120, Part 4a TPST-1120 + nivolumab, Part 4b TPST-1120 + docetaxel, Part 4c TPST-1120 + cetuximab, Part 2 TPST-1120 + nivolumab, Part 4 TPST-1120 + nivolumab
Clinical Study IdentifierNCT03829436
SponsorTempest Therapeutics
Last Modified on2 February 2021

Eligibility

Yes No Not Sure

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 nave 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
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