Efficacy and Safety of Caldonirimab Plus Nimotuzumab for Recurrent or Metastatic Cervical Cancer

• Status: Active, not recruiting
• Trial end date: 2025-11-30
• Target enrollment: 0
• Participant gender: Female

Summary

To evaluated the efficacy and safety of caldonirimab plus nimotuzumab as second-line or later therapy for recurrent or metastatic cervical cancer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Health Science Center of Xi'an Jiaotong University
• Treatments: Nimotuzumab

Criteria

Inclusion Criteria:

1. Age≥18 & ≤80.

2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2.

3. Subjects must have histologically or cytologically confirmed recurrent or metastatic carcinoma of the cervix

4. Patients have received at least one systemic therapy or who cannot tolerate chemotherapy in the recurrent or metastatic setting

5. Has at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator.

6. Has adequate organ function.

7. Life expectancy ≥3 months.

Exclusion Criteria:

1. Concurrent enrollment in another clinical study;

2. Clinically significant hydronephrosis, as determined by the investigator, not alleviated by nephrostomy or ureteral stent;

3. Had received caldonirimab or nimotuzumab before;

4. Known history of testing positive for human immunodeficiency virus (HIV) or known active acquired immunodeficiency syndrome.

5. Known active hepatitis B or C infections (known positive hepatitis B surface antigen [HBsAg] result or positive hepatitis C virus [HCV] antibody with detectable HCV ribonucleic acid [RNA] results).

6. Patients with clinically significant cardio-cerebrovascular disease

7. Known allergy or reaction to any component of the two drugs.