At a glance
ClinicalIndex Comparison RecordPhase 2Recruiting· 130 target
Drug / intervention
BL-B01D1 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 Monotherapy, SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy (BL-B01D1+SI-B003) in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies
In Brief
A Phase 2 clinical trial evaluating BL-B01D1 and SI-B003 for Cervical Cancer. Currently recruiting, targeting 130 participants across 1 site.
Detailed Summary
Objective: To explore the efficacy, safety and tolerability of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in patients with recurrent or metastatic cervical cancer and other gynecological malignancies, and to further explore the optimal dose and mode of combination.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Cancer
CountriesChina
CollaboratorsBaili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Timeline
Phase 2Recruiting
20242025202620272028
First PostedAug 2023
Enrollment StartNov 2023
TodayJul 2026
Primary CompletionDec 2026
Study CompletionDec 2027
First PostedAug 14, 2023
Enrollment StartNov 6, 2023
Primary CompletionDec 1, 2026
Study CompletionDec 1, 2027
TodayJul 1, 2026
Enrollment to primary: 3.1 yearsPosted 2.9 years agoPrimary completion in 5 months
Interventions
BL-B01D1drug
BL-B01D1 was administered by intravenous infusion on D1 and D8 in a 3-week cycle.
SI-B003drug
SI-B003 was administered by intravenous infusion every 3 weeks (Q3W).