NCT05272709

TT-702 in Patients With Advanced Solid Tumours.

CURATE: A Cancer Research UK Phase I/II, Dose Escalation and Expansion Trial of TT-702, A Selective Adenosine A2BR Antagonist, Given Orally as a Monotherapy Agent and in Combination, in Patients With Advanced Solid Tumours

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 188 (estimated)
• Sponsor: Cancer Research UK · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is evaluating the drug candidate TT-702 in patients with advanced solid tumours. The main aims of the trial are to determine the maximum dose of TT-702 that can be given safely to patients alone and in combination with other anti-cancer agents.

Detailed description

TT-702 is a 'small molecule prodrug'. TT-702 is converted into TT-478, which then targets and blocks the function of the 'A2B adenosine receptor'. It is hoped that by blocking this receptor the immune system will become more active in recognising and removing tumour cells. This clinical trial has two phases: * Phase I, dose escalation phase - groups of patients will receive increasing doses of TT-702 to find an optimal dose that best targets the tumours. This phase will consist of both monotherapy and combination escalation cohorts. In the combination escalation cohorts, TT-702 will be evaluated in combination with the androgen receptor (AR) antagonist darolutamide to be assessed in mCRPC. Potential agents for further combination escalation cohorts have not yet been defined. * Phase II, expansion phase - larger groups of patients will receive the selected dose of TT-702 considered to be optimal in the Phase I, dose escalation phase. This phase will consist of three monotherapy expansion cohorts (metastatic castrate resistant prostate cancer \[mCRPC\] cohort, Mismatch Repair \[MMR\]/ Microsatellite Instability \[MSI\] defective tumours cohort and a triple negative breast cancer \[TNBC\] cohort) and combination expansion cohorts. In the combination expansion cohorts, TT-702 will be evaluated in combination with the androgen receptor (AR) antagonist darolutamide to be assessed in mCRPC. Potential agents for further combination expansion cohorts have not yet been defined. The main aims of this trial are to: * Find the maximum dose of TT-702 as a monotherapy and in combination with other anti-cancer drugs that can be given safely to patients. * Define the side effects of TT-702 and how these can be managed. * Determine the pharmacokinetics (PK) and elimination kinetics of TT-702.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	TT-702	TT-702 will be administered orally, once daily, for up to 12 months.
DRUG	Darolutamide	Darolutamide will be administered orally, twice daily, for up to 12 months.

Timeline

• Start date: 2022-01-19
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2022-03-09
• Last updated: 2024-05-13

Locations

3 sites across 1 country: United Kingdom