Phase I/II First-in-Human Study of TT-10 (PORT-6), an Adenosine 2A Receptor Antagonist, and PORT-7, an Adenosine 2B Receptor Antagonist, as Single Agents and in Combination in Participants With Advanced Selected Solid Tumors
Portage Biotech
Summary
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 and TT-10 + TT-4, (Dual Blockade) 2. To determine the maximum tolerated dose or the recommended phase 2 dose of TT-10, TT-4 and TT-10 + TT-4, (Dual Blockade) 3. To obtain a preliminary estimate of efficacy of TT-10, TT-4 and TT-10 + TT-4, (Dual Blockade) in advanced solid tumors.
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-10, TT-4 and TT-10 + TT-4 (Dual Blockade). The Phase Ia portion of the study study will consist of three dose escalation cohorts, to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D), safety and tolerability of TT-10, TT-4, TT-10 + TT-4 and will be conducted in participants with the following advanced cancers: Cohort A (TT-10): Renal cell cancer (RCC), castrate resistant prostate cancer (CRPC), non-small…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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. Participants must be ≥18 years of age. 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: Cohort A - TT-10 dose escalation: 1. RCC: Participants with locally advanced or metastatic RCC that have previously received at…
Interventions
- DrugTT-10
TT-10 orally administered BID
- DrugTT-4
TT-4 is orally administered QD
Locations (3)
- USC Norris Comprehensive Cancer CenterLos Angeles, California
- Norton Cancer InstituteLouisville, Kentucky
- The University of Texas MD Anderson Cancer CenterHouston, Texas