TT-4 and TT-10 as Single Agents and in Combination in Subjects With Advanced Selected Solid Tumors and Pleural Mesothelioma

Part of paid clinical trials in Los Angeles, California.

Sponsor: Portage Biotech
Study ID: NCT04969315
Phase: PHASE1/PHASE2
Status: Recruiting

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Conditions

Castrate Resistant Prostate Cancer
Non Small Cell Lung Cancer
Pleural Mesothelioma Malignant
Renal Cell Cancer

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

TT-10 — DRUG
TT-10 orally administered BID
TT-4 — DRUG
TT-4 is orally administered QD

Study Details

The goal of this clinical trial is to evaluate TT-10, TT-4 and TT-10 + TT-4, (Dual Blockade) in participants with advanced selected solid tumors, who have failed or are not eligible for standard of care. The main questions it aims to answer are: 1. To evaluate the safety and tolerability of TT-10, TT-4 Diacid, and combination therapy (TT-10 + TT-4 Diacid). 2. To determine the maximum tolerated dose (MTD) or phase 2 recommended dose of TT-10, TT-4 Diacid, and combination therapy (TT-10 + TT-4 Diacid). 3. To evaluate safety of combination therapy (TT-10 + TT-4 Diacid).

Key Dates

First listed: Jul 20, 2021
Start date: Jun 23, 2023
Status verified: Sep 2026
Primary completion: Dec 1, 2028
Completion: Mar 1, 2029

Study Design

Enrollment: 35 participants (estimated)
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Arms

Experimental: Cohort A: Dose Escalation
Drug: TT-10 (A2A Receptor Antagonist) * Supplied in capsules for daily oral administration twice a day (BID) * One cycle is considered 28 days * Ascending Dose levels are being explored * Dose Level 1 * Dose Level 2 * Dose Level 3 * Dose Level 4\* \*Additional dose levels may be explored, if appropriate based on emerging safety, PK or pharmacodynamic data
Experimental: Cohort B: Dose Escalation/Safety Lead-In
Drug: TT-4 (A2B Receptor Antagonist) * Supplied in capsules for daily oral administration once a day (QD) * One cycle is considered 28 days * During Cycle 1 (28 days), participants will receive TT-4 monotherapy at the assigned dose level for safety evaluation * Ascending Dose levels are being explored * Dose Level 1 * Dose Level 2 * Dose Level 3\* * \*Additional dose levels or frequency may be explored, if appropriate based on emerging safety, PK or pharmacodynamic data Drug: TT-10 (A2A Receptor Antagonist) * Supplied in capsules for daily oral administration once a day (QD) * One cycle is considered 28 days * During Cycle 2 (28 days), participants may initiate TT-10 + TT-4 at the assigned dose level from Cycle 1 for safety evaluation
Experimental: Cohort-C TT-4 Accelerated Titration w/Optional Intra-Participant Escalation MPM
TT-4 diacid will be administered orally once daily (QD) in 28-day treatment cycles. Dose Levels evaluated in Cohort C are 200 mg QD (Dose Level 0), 400 mg QD (Dose Level 1), and 800 mg QD (Dose Level 2; target dose).