Portage Biotech
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).
This is a Phase 1/1b, multicenter, open-label, non-randomized, multi-cohort study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of TT-10 (A2A receptor antagonist) and TT-4 Diacid (A2B receptor antagonist) administered orally as single agents and, in selected participants, as a sequential add-on combination regimen in participants with advanced selected solid tumors. This study is planned to be conducted at approximately 5 sites in Unites States. The study consists of a Phase 1 dose escalation/safety lead-in and…
To be eligible for inclusion in the dose escalation cohorts or expansion cohorts in this study, participants must meet all of the following criteria: 1. Male or female participants must be ≥18 years of age on the day of signing the ICF. 2. Participants or their legal representative must be able to provide written informed consent to participate in the study prior to the performance of any study-specific procedures. 3. Diagnosis of histologically or cytologically confirmed advanced selected solid tumors: All Cohorts 1. RCC: Participants with locally advanced or metastatic RCC who have p…
TT-10 orally administered BID
TT-4 is orally administered QD