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Monoclonal Antibodies

Study treatment for Gynecological Cancers

Phase 1 & 2
Recruiting
Led By Xiaohua Wu, PHD
Research Sponsored by Sichuan Baili Pharmaceutical Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 24 months
Awards & highlights

Summary

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

Eligible Conditions
  • Gynecological Cancers
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase II: Objective response rate (ORR)
Phase Ib: Recommended Phase II Dose (RP2D)
Secondary study objectives
Phase II: Progression-free survival (PFS)
Phase Ib/II: Anti-drug antibody (ADA)
Phase Ib/II: Cmax
+9 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Study treatmentExperimental Treatment1 Intervention
Participants receive BL-B01D1 as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Find a Location

Who is running the clinical trial?

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.UNKNOWN
40 Previous Clinical Trials
5,344 Total Patients Enrolled
Sichuan Baili Pharmaceutical Co., Ltd.Lead Sponsor
70 Previous Clinical Trials
10,392 Total Patients Enrolled
Xiaohua Wu, PHDPrincipal InvestigatorFudan University
~11 spots leftby Jun 2025
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