NCT04969315

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Portage Biotech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN); who have failed or are not eligible for standard of care treatment. Cohort B (TT-4): Castrate resistant prostate cancer (CRPC), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), endometrial cancer (EC) and ovarian cancer (OC); who have failed or are not eligible for standard of care treatment. Cohort C (TT-10 + TT-4): Tumor types from both cohorts will be included and prioritized based on the data observed.

Conditions

• Renal Cell Cancer
• Castrate Resistant Prostate Cancer
• Non Small Cell Lung Cancer
• Head and Neck Squamous Cell Carcinoma
• Colorectal Cancer (CRC)
• Endometrial Cancer
• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	TT-10	TT-10 orally administered BID
DRUG	TT-4	TT-4 is orally administered QD

Timeline

• Start date: 2023-06-23
• Primary completion: 2026-06-01
• Completion: 2027-12-31
• First posted: 2021-07-20
• Last updated: 2025-04-02

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study