RecruitingPhase 2NCT06042894

A Study of SI-B003 or BL-B01D1+SI-B003 in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of SI-B003 Monotherapy or BL-B01D1+SI-B003 Combination Therapy (BL-B01D1+SI-B003) in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

58 participants

Start Date

Dec 12, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II study is a clinical study to explore the efficacy and safety of SI-B003 monotherapy and BL-B01D1+SI-B003 combination therapy in patients with unresectable locally advanced or recurrent metastatic HER-2 negative breast cancer.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing one or two new treatments — SI-B003 alone or combined with BL-B01D1 — in patients with HER2-negative breast cancer (breast cancer that does not overexpress a protein called HER2) that has come back or spread and has not responded to standard treatments. **You may be eligible if...** - You are 18–75 years old - You have confirmed HER2-negative breast cancer that has spread or cannot be surgically removed - Your cancer has failed standard treatments or no standard treatment is available - You are in generally good health (ECOG status 0–1) - Your life expectancy is at least 3 months **You may NOT be eligible if...** - Your cancer is HER2-positive - You have serious heart, liver, or lung conditions - You have active brain metastases - You are pregnant or breastfeeding 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

DRUGBL-B01D1

BL-B01D1 was administered by intravenous infusion on D1 and D8 in a 3-week cycle.

DRUGSI-B003

SI-B003 was administered by intravenous infusion on D1 in a 3-week cycle.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06042894


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