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Active Not Recruiting NCT05606263

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

Conditions: Cervical Cancer

Sex: Female
Ages: 18 Years – 80 Years
Phase: PHASE2
Enrollment: 55
Sponsor: Health Science Center of Xi'an Jiaotong University

Location: China

Summary

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

Eligibility Criteria

Inclusion Criteria:Age≥18 & ≤80.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2.Subjects must have histologically or cytologically confirmed recurrent or metastatic carcinoma of the cervixPatients have received at least one systemic therapy or who cannot tolerate chemotherapy in the recurrent or metastatic settingHas at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator.Has adequate organ function.Life expectancy ≥3 months.Exclusion Criteria:Concurrent enrollment in another clinical study;Clinically significant hydronephrosis, as determined by the investigator, not alleviated by nephrostomy or ureteral stent;Had received caldonirimab or nimotuzumab before;Known history of testing positive for human immunodeficiency virus (HIV) or known active acquired immunodeficiency syndrome.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).Patients with clinically significant cardio-cerebrovascular diseaseKnown allergy or reaction to any component of the two drugs.

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Source: ClinicalTrials.gov (NCT05606263). StuddyBuddy aggregates publicly available trial information.