An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors (NCT07371663) | Clinical Trial Compass
RecruitingPhase 1/2
An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors
China266 participantsStarted 2025-12-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L;
✓. White blood cell count (WBC) ≥3.0 × 10⁹/L;
✓. Platelet count ≥100 × 10⁹/L;
✓. Hemoglobin (Hb) ≥90 g/L;
✓. Serum albumin ≥30 g/L;
✓. Total bilirubin ≤1.5 × ULN (≤2.0 × ULN for hepatocellular carcinoma or subjects with liver metastases);
✓. ALT and AST ≤3 × ULN (≤5.0 × ULN for hepatocellular carcinoma or subjects with liver metastases);
✓. Alkaline phosphatase (ALP) ≤2.5 × ULN (≤5 × ULN if bone metastases are present);
Exclusion criteria
✕. Poorly controlled hypertension (systolic BP ≥150 mmHg or diastolic BP ≥100 mmHg);
✕. Clinically significant cardiovascular disease within 6 months before the first dose (e.g., myocardial infarction, severe/unstable angina, stroke, ≥Grade 2 congestive heart failure \[NYHA classification\]);
What they're measuring
1
Phase Ib：To determine dose-limiting toxicity (DLT) at each dose level
Timeframe: 21 Days
2
MTD
Timeframe: 21 days
3
RP2D
Timeframe: 21 days
4
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
✕. Arrhythmia (≥Grade 2 per CTCAE v5.0, including QTcF ≥450 ms \[male\] or ≥470 ms \[female\]);
✕. Unexplained fever ≥38.5°C within 14 days before the first dose or active infection requiring systemic therapy;
✕. Active viral hepatitis (HBV DNA ≥500 IU/mL for HBsAg-positive and/or anti-HBc-positive subjects; HCV RNA-positive for anti-HCV-positive subjects; antiviral therapy required for eligible HBV/HCV-positive subjects);
✕. Active syphilis;
✕. Active tuberculosis;
✕. Immunodeficiency (e.g., HIV-positive, congenital/acquired immunodeficiency, organ transplant history);