Actively Recruiting
An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors
Led by Beijing Tide Pharmaceutical Co., Ltd · Updated on 2026-01-28
266
Participants Needed
3
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent.
- At least 18 years old at consent.
- Histologically or cytologically confirmed advanced or metastatic solid tumors with disease progression after standard therapy, no available therapy, intolerance, or refusal of standard therapy.
- Phase Ib: Patients with advanced, recurrent, or refractory solid tumors.
- Phase II: Specific tumor types depending on combination group, including NSCLC, endometrial cancer, ovarian cancer, small cell lung cancer, and other advanced solid tumors.
- At least one measurable tumor lesion per RECIST v1.1.
- Provide sufficient tumor tissue samples for biomarker testing.
- ECOG performance status of 0 or 1 within 7 days before first dose.
- Expected survival of at least 12 weeks.
- Ability to swallow tablets whole.
- Organ function within specified ranges (including blood counts, liver and kidney function, coagulation, heart function).
- Use of medically approved contraception during study and for specified time after last dose for fertile participants.
You will not qualify if you...
- Known primary CNS tumors or symptomatic/uncontrolled brain metastases except stable treated lesions.
- Major surgery, radiotherapy, chemotherapy, or investigational therapy within 4 weeks before first dose (with some exceptions).
- Use of strong CYP3A4 inhibitors or inducers within 14 days before first dose.
- Unresolved grade 2 or higher toxicity from prior therapy except alopecia, pigmentation, or lab abnormalities.
- Inability to swallow tablets or gastrointestinal issues affecting absorption.
- Uncontrolled severe diseases such as poorly controlled hypertension, recent significant cardiovascular disease, arrhythmia, active fever or infection, active viral hepatitis, syphilis, tuberculosis, immunodeficiency, or poorly controlled diabetes.
- Uncontrolled pleural, pericardial effusion, or ascites requiring drainage within 28 days.
- Significant bleeding within 3 months before first dose.
- Chronic corticosteroid or immunosuppressive therapy within 14 days before first dose.
- Active autoimmune disease requiring systemic treatment in past 2 years (for specific groups).
- History of severe allergy to study drugs or excipients.
- Other malignancies within 3 years except certain cured cancers.
- Prior grade 3 or higher immune-mediated adverse events during anti-PD-(L)1 therapy.
- Prior treatment with TCC1727 or similar inhibitors.
- Other severe physical or mental conditions increasing study risk or interfering with results.
- Additional exclusions for specific Phase II cohorts based on tumor mutations or histology.
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Not Yet Recruiting
2
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
Not Yet Recruiting
3
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
Z
Zhengbo Song
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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