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OncoMatch/Clinical Trials/NCT06008054

A Study of SI-B003, BL-B01D1+SI-B003 and BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric Cancer, Colorectal Cancer and Other Gastrointestinal Tumors

Is NCT06008054 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including SI-B003 and BL-B01D1 for esophageal cancer.

Phase 2RecruitingSichuan Baili Pharmaceutical Co., Ltd.NCT06008054Data as of May 2026

Treatment: SI-B003 · BL-B01D1 · PD-1 Monoclonal AntibodyThis phase II study is a clinical study to explore the efficacy and safety of SI-B003 Monotherapy, BL-B01D1+SI-B003 Combination Therapy and BL-B01D1+PD-1 Monoclonal Antibody in patients with locally advanced or metastatic esophageal cancer, gastric cancer, colorectal cancer and other gastrointestinal tumors.

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Extracted eligibility criteria

Cancer type

Esophageal Carcinoma

Gastric Cancer

Colorectal Cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: antitumor therapy (chemotherapy or biological therapy)

Antitumor therapy such as chemotherapy or biological therapy was used within 4 weeks or 5 half-lives before the first dose in this study

Cannot have received: mitomycin (mitomycin)

Mitomycin and nitrosoureas were administered within 6 weeks before the first dose

Cannot have received: nitrosoureas (nitrosoureas)

Mitomycin and nitrosoureas were administered within 6 weeks before the first dose

Cannot have received: oral fluorouracil (fluorouracil)

Oral drugs such as fluorouracil

Cannot have received: antibody-drug conjugate

Exception: Cohort using BL-B01D1, previously treated with an ADC drug with topoisomerase I inhibitor as toxin

Cohort using BL-B01D1, previously treated with an ADC drug with topoisomerase I inhibitor as toxin

Cannot have received: immunomodulatory drugs

Immunomodulatory drugs were administered within 2 weeks before the first dose in this study

Lab requirements

Cardiac function

no severe cardiac dysfunction, left ventricular ejection fraction ≥50%

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

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