RecruitingPhase 2NCT06008054

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

A Phase II Clinical Study to Evaluate 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


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

376 participants

Start Date

Nov 16, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This 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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing several drug combinations — including SI-B003 (an anti-PD-L1 antibody), BL-B01D1 (an antibody-drug conjugate), and a PD-1 antibody — in patients with advanced or metastatic cancers of the esophagus, stomach, colon/rectum, or other gastrointestinal tumors. **You may be eligible if:** - You are between 18 and 75 years old - You have locally advanced or metastatic esophageal, gastric, colorectal, or other gastrointestinal cancer - You have at least one measurable tumor on imaging - You are in good health (ECOG 0–1) - Your organ function (heart, blood, kidneys, liver) meets the required levels **You may NOT be eligible if:** - You received cancer treatment within the past 4 weeks (or 6 weeks for certain drugs) - You require ongoing steroids or immune-suppressing medications - You are pregnant or nursing - You previously received an antibody-drug conjugate with topoisomerase I inhibitor as the toxin (for certain cohorts) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSI-B003

Administered by intravenous infusion every 3 weeks (Q3W).

DRUGBL-B01D1

Administered by intravenous infusion for a cycle of 3 weeks.

DRUGPD-1 Monoclonal Antibody

Administration by intravenous infusion for a cycle of 3 weeks.


Locations(1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

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NCT06008054


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