RecruitingPhase 1Phase 2NCT04969315

TT-10 (PORT-6) and TT-4 (PORT-7) as Single Agents and in Combination in Subjects With Advanced Selected Solid Tumors

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


Sponsor

Portage Biotech

Enrollment

90 participants

Start Date

Jun 23, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing two new experimental cancer drugs — TT-10 and TT-4 — alone and in combination, in people with certain advanced solid tumours including kidney cancer, prostate cancer, bladder cancer, and others. **You may be eligible if...** - You are 18 years or older - You have a confirmed advanced solid tumour that fits one of the specific groups: kidney cancer (renal cell carcinoma), castration-resistant prostate cancer, bladder cancer, or another selected solid tumour depending on the study cohort - You have received prior standard treatments and they are no longer working - You can provide written consent and comply with study visits **You may NOT be eligible if...** - You have not received prior standard therapies for your cancer type - Your tumour type is not included in the eligible diagnoses for this study - Your general health is too poor - You have serious uncontrolled medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTT-10

TT-10 orally administered BID

DRUGTT-4

TT-4 is orally administered QD


Locations(3)

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Norton Cancer Institute

Louisville, Kentucky, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT04969315


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