RecruitingPhase 1Phase 2NCT07371663

An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors

An Open-Label, Multicenter Phase Ib/II Clinical Trial of TCC1727 in Combination With Benmelstobart/Olaparib/Topotecan for Advanced Solid Tumors


Sponsor

Beijing Tide Pharmaceutical Co., Ltd

Enrollment

266 participants

Start Date

Dec 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase Ib/II clinical study. The Phase Ib dose-escalation study aims to evaluate and determine the recommended Phase II dose (RP2D) of TCC1727 in combination with benmelstobart /olaparib /topotecanfor patients with advanced solid tumors. The Phase II expansion study will assess the efficacy and safety of TCC1727 combined with benmelstobart /olaparib/topotecanin selected advanced solid tumor indications. The study pre-specifies three treatment combinations, with Combination 1 (TCC1727 + benmelstobart) being prioritized for initial evaluation. The decision to proceed with Combination 2 and Combination 3will be based on clinical data from Combination 1.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing TCC1727 — a new experimental drug — in combination with other cancer treatments in adults with advanced or metastatic solid tumors, including lung cancer, endometrial cancer, colorectal cancer, bladder cancer, and stomach cancer. **You may be eligible if...** - You are 18 or older - You have been diagnosed with an advanced solid tumor that has progressed despite standard treatments, or for which no standard treatment is available - Your specific cancer type may qualify depending on which treatment combination group you are enrolled in (e.g., lung cancer, endometrial cancer, gastric cancer, etc.) - You are in acceptable physical condition and your organs function within required limits **You may NOT be eligible if...** - You have active brain metastases causing symptoms - You have a serious autoimmune disease requiring systemic treatment - You have HIV, active hepatitis B or C, or active tuberculosis - You have had a stem cell or organ transplant - You are pregnant or breastfeeding 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

DRUGTCC1727 tablet 90mg

TCC1727 tablets 90 mg, orally, twice daily (bid), continuous dosing in 21-day cycles until disease progression

DRUGTCC1727 tablet 120mg

TCC1727 tablets 120 mg, orally, twice daily (bid), continuous dosing in 21-day cycles until disease progression

DRUGTCC1727 tablet 160mg

TCC1727 tablets 160 mg, orally, twice daily (bid), continuous dosing in 21-day cycles until disease progression

COMBINATION_PRODUCTbenmelstobart Injection

Administer 1200 mg per dose via intravenous infusion on Day 1 of every 3-week cycle until disease progression.


Locations(3)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT07371663


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