TT-4 As a Single Agent in Subjects with Advanced Selected Solid Tumors

Phase 1

Withdrawn

• Conditions: Colorectal Cancer; Gastric Cancer; Hepatocellular Carcinoma; Pancreatic Cancer
• Interventions: Drug: TT-4

• Registration Number: NCT04976660
• Lead Sponsor: Tarus Therapeutics, Inc.

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of orally administered TT-4 in subjects with advanced selected solid tumors. The dose escalation portion of the study will determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of TT-4.

Detailed Description

Multicenter, open-label dose-escalation Phase I/II clinical study, designed to evaluate the safety, tolerability, PK, PD, anti-tumor activity, and efficacy of TT-4 in subjects diagnosed with Colorectal Cancer (CRC), Gastric cancer (GC), Hepatocellular Carcinoma (HCC) and locally advanced, unresectable, or metastatic Pancreatic Cancer (PANC); who have failed or are not eligible for standard of care treatment.

The study will be conducted in two phases. Dose escalation (Phase 1) will be to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D), safety and tolerability of TT-4 in subjects with advanced subjects diagnosed with Colorectal Cancer (CRC), Gastric cancer (GC), Hepatocellular Carcinoma (HCC) and locally advanced, unresectable, or metastatic Pancreatic Cancer (PANC); who have failed or are not eligible for standard of care treatment. Dose expansion (Phase 2) will be to further explore the safety and tolerability of the MTD and/or RP2D, PK, PD, antitumor activity, and efficacy of TT-4.

Study Timeline

• Study First Submitted: 2021-07-06
• Study First Submitted QC: 2021-07-14
• Study First Posted: 2021-07-26
• Study Start: 2022-12-15
• Primary Completion: 2023-06-01
• Study Completion: 2023-09-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Multiple Ascending Dose	TT-4	3+3 Dose escalation until MTD and/or R2PD of TT-4 is determined

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)	This is defined as complete response (CR) or PR according to RECIST 1.1 and from the first dose until documented confirmed disease progression.
Number of subjects with Dose Limiting Toxicities (DLTs) of TT-4 during the dose escalation phase	28 Days	All toxicities will be graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Define the maximum tolerated dose (MTD) or phase 2 recommended dose of TT-4during the dose escalation phase	Up to 1 year

Secondary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events (TEAEs) overall and by severity, seriousness and relatedness.	Through study completion, an average of 1 year	Safety assessments will be performed on a regular basis using physical examination, spontaneous AE reporting, scheduled and unscheduled laboratory assessments, and other diagnostic evaluations as indicated. Adverse events will be reported using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Duration of Response (DoR)	From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)]	Time from first confirmed documented objective response (CR or PR) to the date of first confirmed documented objective progression of disease (PD) or death due to any cause whichever occurs first. If a subject has not had an event (PD or death), DR is censored at the date of last adequate tumor assessment.
Progression Free Survival (PFS)	From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)]	Time from first dose to the date of the first confirmed documented objective progression of disease (PD) or death due to any cause, whichever occurs first.
Peak serum concentration (Cmax) of TT-4	Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose	PK Parameter
Area under the serum concentration versus time curve (AUC) of TT-4	Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose	PK Parameter
Half-life of TT-4	Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose	PK Parameter