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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 (Jun 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 Jun 2026Location: China

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

Treatments studied

Other

SI-B003BL-B01D1PD-1 Monoclonal Antibody

Cancer type

Esophageal Carcinoma

Gastric Cancer

Colorectal Cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT06008054 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior antitumor therapy (chemotherapy or biological therapy), mitomycin, nitrosoureas disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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