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An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

NCT07371663•Beijing Tide Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•-Voluntarily participate in this study and sign the informed consent form.
•At the time of signing the informed consent, subjects must be ≥18 years of age (inclusive).
•Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumors and have experienced disease progression following prior standard anti-tumor therapy; or subjects must have no available standard therapy, be intolerant to or refuse standard therapy, or meet the specific requirements for the corresponding phase and group as follows:
•* Phase Ib :Subjects with advanced, recurrent, or refractory solid tumors, which may include (but are not limited to) the specific tumor types in Phase II.
•* Phase II Study:Based on different combination therapy groups, subjects with the following specific tumor types (different population cohorts):
•TCC1727 combined with Benmelstobart Group:
•The study will enroll subjects with advanced solid tumors lacking standard therapies, including but not limited to non-small cell lung cancer (NSCLC), endometrial cancer, and other advanced solid tumors (e.g., colorectal cancer, urothelial carcinoma, gastric cancer, and gastroesophageal junction cancer):
•Cohort 1 (NSCLC):Patients with histologically or cytologically confirmed locally advanced or metastatic NSCLC who are eligible for second- or third-line therapy. Patients must have received prior therapy with an anti-PD-(L)1-containing regimen (either as monotherapy or in combination) and a platinum-based doublet regimen for locally advanced or metastatic NSCLC.
•Subgroup 1: ATM mutation. Subgroup 2: ATM wild-type, with or without other DDR functional defects.
•Cohort 2 (Endometrial Cancer):Patients with histopathologically confirmed recurrent or metastatic advanced endometrial cancer who have received at least one prior platinum-based chemotherapy and immune checkpoint inhibitor (PD-1 or PD-L1) therapy (sequential or concurrent therapy allowed; sequential therapy refers to platinum-based chemotherapy followed by immune checkpoint inhibitor maintenance therapy).
+54 more criteria

Exclusion Criteria

•Known primary central nervous system (CNS) tumors (including meningeal tumors); symptomatic brain metastases, spinal cord compression, carcinomatous meningitis, or uncontrolled CNS metastases. Exceptions: Subjects with completely resected and/or irradiated CNS metastases that are stable or improved for ≥4 weeks before screening (no evidence of brain edema and no need for corticosteroids or anticonvulsants). Asymptomatic brain metastases \<1 cm in diameter without surrounding edema are also allowed.
•Major surgery, radiotherapy, chemotherapy, or other investigational anti-tumor therapy completed \<4 weeks before the first dose (exceptions: small-molecule anti-tumor therapy completed \>5 half-lives or \>10 days before the first dose, whichever is longer; palliative radiotherapy completed \>2 weeks before the first dose).
•Use of strong CYP3A4 inhibitors or inducers within 14 days before the first dose (e.g., rifampin, rifapentine, St. John's wort, carbamazepine, phenytoin, barbiturates, ketoconazole, itraconazole, clarithromycin, voriconazole, atazanavir, ritonavir, saquinavir, grapefruit juice).

Locations (3)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Key Dates

Start Date

December 3, 2025

Primary Completion Date

September 30, 2028

Completion Date

June 30, 2029

Last Updated

January 28, 2026

Enrollment

266

ESTIMATED participants

Conditions

Solid CancersNSCLC (Advanced Non-small Cell Lung Cancer)Gastric (Stomach) CancerEndometrial CancerMalignant Melanoma

Interventions

TCC1727 tablet 90mg

DRUG

TCC1727 tablet 120mg

DRUG

TCC1727 tablet 160mg

DRUG

benmelstobart Injection

COMBINATION_PRODUCT

Contacts

Zhengbo Song

CONTACT

+86 13857153345 songzb@zjcc.org.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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