Trials / Recruiting
RecruitingNCT07371663
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
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 266 (estimated)
- Sponsor
- Beijing Tide Pharmaceutical Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Solid Cancers
- NSCLC (Advanced Non-small Cell Lung Cancer)
- Gastric (Stomach) Cancer
- Endometrial Cancer
- Malignant Melanoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TCC1727 tablet 90mg | TCC1727 tablets 90 mg, orally, twice daily (bid), continuous dosing in 21-day cycles until disease progression |
| DRUG | TCC1727 tablet 120mg | TCC1727 tablets 120 mg, orally, twice daily (bid), continuous dosing in 21-day cycles until disease progression |
| DRUG | TCC1727 tablet 160mg | TCC1727 tablets 160 mg, orally, twice daily (bid), continuous dosing in 21-day cycles until disease progression |
| COMBINATION_PRODUCT | benmelstobart Injection | Administer 1200 mg per dose via intravenous infusion on Day 1 of every 3-week cycle until disease progression. |
Timeline
- Start date
- 2025-12-03
- Primary completion
- 2028-09-30
- Completion
- 2029-06-30
- First posted
- 2026-01-28
- Last updated
- 2026-01-28
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT07371663. Inclusion in this directory is not an endorsement.