Efficacy and Safety of Caldonirimab Plus Nimotuzumab for Recurrent or Metastatic Cervical Cancer (GCR-05)

Health Science Center of Xi'an Jiaotong University

Status and phase: Enrolling; Phase 2

Conditions: Cervical Cancer

Treatments: Drug: Caldonirimab and Nimotuzumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05606263

GCR-5

Details and patient eligibility

About

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

Full description

Caldonirimab, a PD-1/CTLA-4 bispecific antibody, has shown promising efficacy and tolerable toxicity in the first-line treatment of recurrent or metastatic cervical cancer. In this study, patients with recurrent or metastatic cervical cancer, after failure of first-line platinum-containing chemotherapy or intolerance to chemotherapy, will be included in this study according to the prescribed criteria in the protocal. Nimotuzumab 400 mg/time, intravenous injection, q2w, a total of 8 times; Caldonirimab 6 mg/Kg, q2w. Assess objective response rate; disease control rate; duration of overall response and safety ( adverse event).

Enrollment: 55 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Caldonirimab and nimotuzumab

Experimental group

Description:

Caldonirimab combined with nimotuzumab therapy

Treatment:

Drug: Caldonirimab and Nimotuzumab