RecruitingPhase 1Phase 2NCT05803018

A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Recurrent or Metastatic Gynecological Malignancies

A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-B01D1 for Injection in Patients With Multiple Solid Tumors, Including Recurrent or Metastatic Gynecological Malignancies


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

38 participants

Start Date

Jun 25, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

A phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of BL-B01D1 for injection in patients with multiple solid tumors, including recurrent or metastatic gynecological malignancies.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new antibody-drug treatment called BL-B01D1 for women with gynecological cancers (such as ovarian, cervical, or endometrial cancer) that have returned or spread and no longer respond to standard therapies. **You may be eligible if:** - You are between 18 and 75 years old - You have been diagnosed with a recurrent or metastatic gynecological cancer (confirmed by biopsy or pathology) - Standard treatments have failed, were not tolerated, or are not available for your cancer type - You have at least one measurable tumor on imaging - You are in good general health (ECOG score 0 or 1) - Your heart, blood, kidneys, and liver are functioning adequately - You are expected to live at least 3 months **You may NOT be eligible if:** - You have had certain prior heart treatments or have poor heart function - Side effects from prior cancer treatments have not resolved - You are pregnant or breastfeeding - Your urine protein levels are too high 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBL-B01D1

Administration by intravenous infusion


Locations(1)

Fudan University ShangHai Cancer Center

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05803018


Related Trials