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OncoMatch/Clinical Trials/NCT07371663

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

Is NCT07371663 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including TCC1727 tablet 90mg and TCC1727 tablet 120mg for solid cancers.

Phase 1/2RecruitingBeijing Tide Pharmaceutical Co., LtdNCT07371663Data as of May 2026

Treatment: TCC1727 tablet 90mg · TCC1727 tablet 120mg · TCC1727 tablet 160mg · benmelstobartThis 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.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Endometrial Cancer

Melanoma

Biomarker criteria

Required: ATM mutation

ATM mutation

Required: ATM wild-type

ATM wild-type, with or without other DDR functional defects

Required: EGFR wild-type

Exclude subjects with known EGFR mutations

Required: ALK wild-type

Exclude subjects with known ALK mutations

Required: ROS1 wild-type

Exclude subjects with known ROS1 mutations

Required: BRAF wild-type

Exclude subjects with known BRAF mutations

Required: MET wild-type

Exclude subjects with known MET mutations

Required: RET wild-type

Exclude subjects with known RET mutations

Required: KRAS wild-type

Exclude subjects with known KRAS mutations

Required: NRAS wild-type

Exclude subjects with known NRAS mutations

Required: MSI MSS

Exclude KRAS/NRAS/BRAF mutations or MSI-H status

Disease stage

Metastatic disease required

advanced or metastatic solid tumors

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: anti-PD-(L)1 therapy — locally advanced or metastatic NSCLC

prior therapy with an anti-PD-(L)1-containing regimen (either as monotherapy or in combination)

Must have received: platinum-based chemotherapy — locally advanced or metastatic NSCLC

platinum-based doublet regimen for locally advanced or metastatic NSCLC

Must have received: platinum-based chemotherapy — recurrent or metastatic advanced endometrial cancer

at least one prior platinum-based chemotherapy

Must have received: immune checkpoint inhibitor (PD-1 or PD-L1) therapy — recurrent or metastatic advanced endometrial cancer

immune checkpoint inhibitor (PD-1 or PD-L1) therapy

Must have received: platinum-based chemotherapy combined with PD-(L)1 therapy — SCLC

progressed after platinum-based chemotherapy combined with PD-(L)1 therapy

Cannot have received: ATR inhibitors, ATM inhibitors, WEE1 inhibitors, CHK1/CHK2 inhibitors (TCC1727)

Prior treatment with TCC1727, other ATR inhibitors, or cell cycle checkpoint inhibitors (e.g., ATM inhibitors, WEE1 inhibitors, CHK1/CHK2 inhibitors)

Cannot have received: Olaparib (Olaparib Tablets)

Exception: Cohort 4 Subgroup 2 allows subjects who have not received Olaparib Tablets

Subjects who have experienced disease progression after prior Olaparib Tablets therapy (maintenance or subsequent therapy). Subjects must not have received further treatment after progression on Olaparib Tablets.

Lab requirements

Blood counts

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; APTT ≤1.5 × ULN and INR or PT ≤1.5 × ULN (for subjects not receiving anticoagulation therapy)

Kidney function

Serum creatinine ≤1.5 × ULN or creatinine clearance (CrCL) ≥60 mL/min (Cockcroft-Gault formula)

Liver function

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); Serum albumin ≥30 g/L

Cardiac function

QTc <450 ms (male) or <470 ms (female), LVEF ≥50%

Organ function within the following ranges within 7 days prior to the first dose of study drug (no blood component or growth factor therapy within 14 days prior to the first dose): 1. Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L; 2. White blood cell count (WBC) ≥3.0 × 10⁹/L; 3. Platelet count ≥100 × 10⁹/L; 4. Hemoglobin (Hb) ≥90 g/L; 5. Serum albumin ≥30 g/L; 6. Total bilirubin ≤1.5 × ULN (≤2.0 × ULN for hepatocellular carcinoma or subjects with liver metastases); 7. ALT and AST ≤3 × ULN (≤5.0 × ULN for hepatocellular carcinoma or subjects with liver metastases); 8. Alkaline phosphatase (ALP) ≤2.5 × ULN (≤5 × ULN if bone metastases are present); 9. Serum creatinine ≤1.5 × ULN or creatinine clearance (CrCL) ≥60 mL/min (Cockcroft-Gault formula); 10. APTT ≤1.5 × ULN and INR or PT ≤1.5 × ULN (for subjects not receiving anticoagulation therapy); 11. QTc <450 ms (male) or <470 ms (female), LVEF ≥50%.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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