Advanced Solid Tumors Clinical Trial
Official title:
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
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04972981 -
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of ADCT-901 in Participants With Selected Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT05086822 -
A Study of Irinotecan Hydrochloride Liposome in Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT03260322 -
A Multiple-dose Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
| Recruiting |
NCT06040541 -
Study of RMC-9805 in Participants With KRASG12D-Mutant Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05862831 -
Clinical Study of PM1003 in Phase I/IIa Treatment of Advanced Malignant Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03641794 -
Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Healthy Volunteers
|
Phase 1 | |
| Terminated |
NCT03665129 -
IPH5401 (Anti-C5aR) in Combination With Durvalumab in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Not yet recruiting |
NCT06413680 -
A First-In Human (FIH) Trial to Find Out if REGN10597 is Safe and How Well it Works for Adult Participants With Advanced Solid Organ Malignancies
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05914116 -
A Study of DB-1311 in Advanced/Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT01693562 -
A Phase 1/2 Study to Evaluate MEDI4736
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04387916 -
A Study of KC1036 in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT04095273 -
Study to Test How Well Patients With Advanced Solid Tumors Respond to Treatment With the Elimusertib in Combination With Pembrolizumab, to Find the Optimal Dose for Patients, How the Drug is Tolerated and the Way the Body Absorbs, Distributes and Discharges the Drug
|
Phase 1 | |
| Not yet recruiting |
NCT03692520 -
Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCT200 in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT02997176 -
An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800)
|
Phase 1 | |
| Recruiting |
NCT04446260 -
A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT06239155 -
A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Terminated |
NCT02253992 -
An Investigational Immuno-therapy Study to Determine the Safety of Urelumab Given in Combination With Nivolumab in Solid Tumors and B-cell Non-Hodgkin's Lymphoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06076291 -
An Open-label Study of SG1827 in Subjects With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT03545971 -
A Study of IBI310 for the Treatment of Patients With Advanced Solid Tumors.
|
Phase 1 |