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OncoMatch/Clinical Trials/NCT07292038

Safety and Pharmacokinetics of NM6603 in Chinese Patients With Advanced Solid Tumors

Is NCT07292038 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies NM6603 for cancers.

Phase 1RecruitingNucMito Pharmaceuticals Co. Ltd.NCT07292038Data as of May 2026

Treatment: NM6603This study is to assess the MTD and PK of NM6603 in adult patients with advanced solid tumors.

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Extracted eligibility criteria

Disease stage

Metastatic disease required

Advanced solid tumors (primarily advanced colorectal cancer or triple-negative breast cancer) confirmed by histology or cytology

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: standard therapy

Prior adequate standard therapy with documented progression or intolerance, or lack of available standard therapy options, or contraindications to standard therapy

Cannot have received: drug targeting the same mechanism of action or molecular target

Prior treatment with a drug targeting the same mechanism of action or molecular target

Cannot have received: chemotherapy

Chemotherapy, biologic therapy, macromolecular targeted therapy, or radiotherapy within 4 weeks before first dose

Cannot have received: biologic therapy

Chemotherapy, biologic therapy, macromolecular targeted therapy, or radiotherapy within 4 weeks before first dose

Cannot have received: macromolecular targeted therapy

Chemotherapy, biologic therapy, macromolecular targeted therapy, or radiotherapy within 4 weeks before first dose

Cannot have received: radiotherapy

Chemotherapy, biologic therapy, macromolecular targeted therapy, or radiotherapy within 4 weeks before first dose

Cannot have received: oral fluoropyrimidines

Oral fluoropyrimidines or other small molecule targeted agents received within 2 weeks or 5 half-lives before first dose (whichever is longer)

Cannot have received: small molecule targeted agents

Oral fluoropyrimidines or other small molecule targeted agents received within 2 weeks or 5 half-lives before first dose (whichever is longer)

Cannot have received: traditional Chinese medicine or herbal products with antitumor activity

Use of traditional Chinese medicine or herbal products with antitumor activity within 2 weeks before first dose

Lab requirements

Blood counts

Absolute neutrophil count 1500 per mm3 or greater; Platelet count 100000 per mm3 or greater with no transfusion or growth factor use within 14 days before first dose; Hemoglobin 9.0 g/dL or greater with no transfusion or stimulating factors within 14 days before first dose

Kidney function

Creatinine clearance 60 mL/min or greater (Cockcroft-Gault formula)

Liver function

Total bilirubin 1.5x ULN or less (patients with Gilbert syndrome allowed); AST and ALT 2.5x ULN or less without liver metastasis, or 5x ULN or less with liver metastasis

Cardiac function

INR 1.5x ULN or less and APTT 1.5x ULN or less; Left ventricular ejection fraction less than 50 percent, QTcF greater than 450 ms

Adequate organ and bone marrow function as defined below: Absolute neutrophil count 1500 per mm3 or greater; Platelet count 100000 per mm3 or greater with no transfusion or growth factor use within 14 days before first dose; Hemoglobin 9.0 g/dL or greater with no transfusion or stimulating factors within 14 days before first dose; Total bilirubin 1.5 times upper limit of normal (ULN) or less (patients with Gilbert syndrome allowed); AST and ALT 2.5 times ULN or less without liver metastasis, or 5 times ULN or less with liver metastasis; Creatinine clearance 60 mL/min or greater (Cockcroft-Gault formula); INR 1.5 times ULN or less and APTT 1.5 times ULN or less

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

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