A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies
NCT05990803 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130
Last updated 2025-09-26
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.
Conditions
Interventions
- DRUG
-
BL-B01D1
BL-B01D1 was administered by intravenous infusion on D1 and D8 in a 3-week cycle.
- DRUG
-
SI-B003
SI-B003 was administered by intravenous infusion every 3 weeks (Q3W).
Sponsors & Collaborators
-
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
collaborator INDUSTRY -
Sichuan Baili Pharmaceutical Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Lingying Wu, PHD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-06
- Primary Completion
- 2026-12-31
- Completion
- 2027-12-31
Countries
- China
Study Locations
More Related Trials
-
A Study in Recurrent or Metastatic Cervical Cancer Patients With PD-L1 Positive
NCT03808857 ·Status: UNKNOWN ·Phase: PHASE2
-
Efficacy and Safety of LB1410 Plus Lenvatinib With or Without LB4330 in Advanced Recurrent/Metastatic Cervical Cancer
NCT07177716 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2/PHASE3
-
A Study of Sintilimab Combined With Concurrent Chemoradiation Therapy in Locally Advanced Cervical Cancer
NCT05105672 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study of SHR-1701 Plus Platinum-containing Chemotherapy With or Without BP102 (Bevacizumab) as First-line Treatment in Cervical Cancer
NCT05179239 ·Status: TERMINATED ·Phase: PHASE3
-
SHR-A1811 Combination Regimen for the Treatment of Recurrent or Metastatic Cervical Cancer
NCT06859775 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Safety and Efficacy Study of First-line Treatment With QL1706 Plus Chemotherapy With or Without Bevacizumab in Women With Recurrent, or Metastatic Cervical Cancer
NCT05179317 ·Status: UNKNOWN ·Phase: PHASE2
-
A Phase II Study to Evaluate the Efficacy and Safety of Salvage Preoperative PD-1 Inhibitor Combined with Chemotherapy Neoadjuvant Therapy in Recurrent and Metastatic LPSCC/HPSCC
NCT06793761 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
SKB264 Plus QL1706 in Recurrent or Metastatic Cervical Cancer
NCT07256236 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of GLS-010 Plus Platinum-containing Chemotherapy±Bevacizumab as First-line Treatment for Persistent, Recurrent, or Metastatic Cervical Cancer
NCT05798819 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Clinical Trial of SIBP-03 in Patients With Head and Neck Squamous Cell Carcinoma
NCT06194656 ·Status: RECRUITING ·Phase: PHASE2
-
A Phase II Trial of SHR-A1811 in HER2-Expressing Recurrent/Metastatic Cervical Cancer
NCT07051486 ·Status: RECRUITING ·Phase: PHASE2
-
Clinical Study to Evaluate the Efficacy and Safety of Nab-Paclitaxel Combined With Cisplatin and Sintilimab in Neoadjuvant Treatment of Locally Advanced Cervical Cancer
NCT07088731 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Phase III Study of S-1 + Cisplatin vs Cisplatin in Cervical Cancer
NCT00770874 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety Study of First-line Treatment With SG001 Plus Chemotherapy ± Bevacizumab Versus Placebo Plus Chemotherapy ±Bevacizumab for Recurrent, or Metastatic Cervical Cancer With PD-L1 Positive (CPS≥1)
NCT05715840 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
QL1706 in Patients With Recurrent and Metastatic Cervical Cancer Resistant to Prior PD-1/PD-L1 Antibody Therapy
NCT07141186 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Efficacy and Safety of Caldonirimab Plus Nimotuzumab for Recurrent or Metastatic Cervical Cancer
NCT05606263 ·Status: RECRUITING ·Phase: PHASE2
-
Neoadjuvant Immunochemotherapy for Locally Advanced Cervical Cancer: a Prospective, Single-arm, Phase II Clinical Trial
NCT07003620 ·Status: RECRUITING ·Phase: PHASE2
-
Apatinib and Chemotherapy Sequential Treatment With Cervical Cancer
NCT03029013 ·Status: UNKNOWN ·Phase: NA
-
A Study of Chemoradiotherapy With SHR-1316 For Treatment of Locally Advanced Cervical Cancer
NCT06237257 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Clinical Study on the Safety, Pharmacokinetics, and Efficacy of ScTIL (Genetically Modified Tumor Infiltrating Lymphocytes) in the Treatment of Gynecological Malignancies
NCT05342506 ·Status: UNKNOWN ·Phase: PHASE2
-
A Phase II Study of Balstilimab Independently or in Combination With Zalifrelimab in Advanced Cervical Cancer
NCT05033132 ·Status: WITHDRAWN ·Phase: PHASE2
-
Randomized Control Trial on Efficacy and Safety of Concurrent and Adjuvant Chemotherapy for the Cervical Cancer
NCT02703961 ·Status: UNKNOWN ·Phase: PHASE3
-
Study of the SG001 Injection for Patients With Relapsed or Metastatic Uterine Cervical Cancer
NCT04886700 ·Status: UNKNOWN ·Phase: PHASE2
-
Real-world Study of Serplulimab in 2L and Above Treatment of Cervical Cancer
NCT05883670 ·Status: RECRUITING
-
Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor in Advanced Cervical Cancer
NCT06391190 ·Status: RECRUITING ·Phase: PHASE1/PHASE2