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

NOT ENROLLING
Protocol # :
19-741
Conditions
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
Phase
I
Disease Sites
Neuroendocrine/Carcinoid
Gastroesophageal Junction
Gallbladder/Biliary
Lip, Oral Cavity and Pharynx
Esophagus
Stomach
Small Intestine
Colon
Rectum
Anus
Liver
Pancreas
Other Digestive Organ
Larynx
Lung
Other Respiratory and Intrathoracic Organs
Bones and Joints
Soft Tissue
Mycosis Fungoides
Other Skin
Breast
Cervix
Corpus Uteri
Ovary
Other Female Genital
Prostate
Other Male Genital
Urinary Bladder
Kidney
Other Urinary
Eye and Orbit
Brain and Nervous System
Thyroid
Unknown Sites
Ill-Defined Sites
Other Endocrine System
Kaposi's Sarcoma
Melanoma, Skin
Principal Investigator
Gandhi, Leena

Trial Description

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.

Eligibility Requirements

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

19-741