Actively Recruiting
An Open-Label, Multicenter Phase Ib/II Trial of TCC1727 with Benmelstobart, Olaparib, or Topotecan for Advanced Solid Tumors
Led by Beijing Tide Pharmaceutical Co., Ltd · Updated on 2026-01-28
266
Participants Needed
3
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase Ib/II clinical trial to evaluate the use of TCC1727 combined with benmelstobart, olaparib, or topotecan in patients with advanced solid tumors. The Phase Ib part focuses on finding the right dose of TCC1727 with benmelstobart, while the Phase II expansion will assess the safety and effectiveness of these combinations in specific tumor types including non-small cell lung cancer, endometrial cancer, ovarian cancer, small cell lung cancer, and other advanced solid tumors. This study aims to provide additional treatment options for patients who have progressed after or cannot tolerate standard therapies. The trial includes three dose levels of TCC1727 tablets taken orally twice daily in 21-day cycles, combined with benmelstobart administered by intravenous infusion every 3 weeks until the disease progresses. Initially, the combination of TCC1727 and benmelstobart is prioritized, with potential evaluation of combinations including olaparib or topotecan based on emerging clinical data. Participants continue treatment as long as they benefit or have no unacceptable side effects. Participants will undergo evaluations to monitor treatment-related side effects, tumor response using imaging criteria, and pharmacokinetic assessments of TCC1727 at specified intervals. Safety monitoring includes checking blood counts, organ function, and heart health before and during treatment. The main outcomes include identifying dose-limiting toxicities, determining the recommended dose for Phase II, and measuring response rates, disease control, survival, and adverse events. The study is planned to continue until mid-2029, with ongoing assessments throughout the treatment period.
CONDITIONS
Brief 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 time of consent.
- Have confirmed advanced or metastatic solid tumors with disease progression after prior standard therapy or no available standard treatment.
- Specific tumor types based on study phase and combination group.
- Presence of at least one measurable lesion per RECIST v1.1.
- Provide sufficient tumor tissue samples for biomarker testing.
- ECOG performance status score of 0-1 within 7 days before first dose.
- Expected survival of at least 12 weeks.
- Ability to swallow tablets whole and maintain this method.
- Meet specified organ function criteria within 7 days before first dose.
- Use medically approved contraception during the study and for specified periods after last dose if applicable.
You will not qualify if you...
- Primary CNS tumors or uncontrolled CNS metastases, except stable or asymptomatic brain metastases.
- Recent major surgery, radiotherapy, chemotherapy, or investigational therapy within defined timeframes before first dose.
- Use of strong CYP3A4 inhibitors or inducers within 14 days before first dose.
- Unresolved Grade 2 or higher toxicity from prior therapy (except certain exceptions).
- Inability to swallow tablets or gastrointestinal dysfunction affecting drug absorption.
- Uncontrolled severe diseases including poorly controlled hypertension, significant cardiovascular disease, arrhythmias, active infections, immunodeficiency, or uncontrolled diabetes.
- Uncontrolled fluid accumulations or significant bleeding risks.
- Recent systemic corticosteroid or immunosuppressive therapy.
- Active autoimmune disease requiring systemic treatment in past 2 years (with exceptions).
- History of severe allergic reactions to study drugs.
- Other malignancies within 3 years except certain cured cancers.
- Prior Grade 3 or higher immune-mediated adverse events from anti-PD-(L)1 therapy.
- Prior treatment with TCC1727 or related inhibitors.
- Other severe conditions increasing risk or interfering with study.
- Additional exclusions based on tumor mutation status or cancer subtype for specific cohorts.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression
Participants receive TCC1727 tablets orally twice daily in 21-day cycles combined with benmelstobart intravenous infusion on Day 1 of each cycle until disease progression.
Visits every 3 weeks corresponding to each treatment cycle
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
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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