OncoMatch/Clinical Trials/NCT04969315
TT-4 and TT-10 as Single Agents and in Combination in Subjects With Advanced Selected Solid Tumors and Pleural Mesothelioma
Official title: A Phase 1/1b, Open-Label, First-in-Human Multicenter Study to Assess the Safety, Tolerability, Preliminary Efficacy, Pharmacokinetics, and Pharmacodynamics of Oral TT-10 (an Adenosine 2A Receptor Antagonist), and TT-4 Diacid (an Adenosine 2B Receptor Antagonist), as Single Agents and in Combination in Participants With Advanced Selected Solid Tumors
Is NCT04969315 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies multiple treatments including TT-10 and TT-4 for renal cell cancer.
Treatment: TT-10 · TT-4 — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Renal Cell Carcinoma
Prostate Cancer
Non-Small Cell Lung Carcinoma
Mesothelioma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — advanced RCC
RCC: Participants with locally advanced or metastatic RCC who have previously received at least two prior standard of care systemic regimens for advanced disease. Prior exposure to a checkpoint inhibitor and/or vascular endothelial growth factor (VEGF) targeted therapy is permitted but not required. Prior HIF-2α inhibitor therapy is permitted and may count toward the number of prior systemic regimens.
Must have received: second-generation hormonal agent — metastatic CRPC
CRPC: Participants with metastatic CRPC who have previously received a second-generation hormonal agent (unless contraindicated)
Must have received: taxane-based chemotherapy — metastatic CRPC
CRPC: Participants with metastatic CRPC who have previously received ... a taxane-based chemotherapy.
Lab requirements
Blood counts
ANC ≥1.5 × 10^9/L; Platelet count ≥100 × 10^9/L; Hemoglobin ≥9.0 g/dL
Kidney function
Serum creatinine clearance ≥30 mL/min per Cockcroft-Gault formula
Liver function
Total bilirubin <1.5 × ULN (unless elevated due to Gilbert's syndrome); ALT/AST ≤2.5 × ULN (≤5 × ULN for participants with known hepatic metastases)
Participants must have adequate hematologic function...adequate hepatic function...adequate renal function...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- USC Norris Comprehensive Cancer Center · Los Angeles, California
- The University of Texas MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04969315 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received systemic therapy and second-generation hormonal agent.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages