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

Launched by XI'AN JIAOTONG UNIVERSITY · Oct 31, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness and safety of two medications, caldonirimab and nimotuzumab, for women with recurrent or metastatic cervical cancer. This means they are studying how well these drugs can help patients whose cervical cancer has come back or spread after receiving other treatments. The trial is currently looking for women aged 18 to 80 who have been diagnosed with this type of cancer, have already had at least one type of treatment, and have measurable signs of their cancer.

Participants in the trial can expect to receive either of the two medications and will be monitored closely by healthcare professionals. To join the study, women must be in reasonably good health, meaning they can perform daily activities and have a life expectancy of at least three months. However, there are certain conditions that would exclude someone from participating, such as severe kidney issues or a history of serious heart or liver diseases. This trial aims to find out if these new drug combinations can be a helpful option for women facing this challenging diagnosis.

Gender

FEMALE

Eligibility 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.