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

NCT05606263 | Unknown Phase 2

• 1 other identifier: GCR-5
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cervical Cancer

Keywords

cervical cancer; Caldonirimab; Nimotuzumab

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1

  2 years

Secondary Outcomes (4)

• Disease control rate (DCR)

  2 years

• Duration of response (DoR)

  2 years

• Progression-free survival (PFS)

  2 years

• Adverse events (AEs)

  90 days

Study Arms (1)

Caldonirimab and nimotuzumab

EXPERIMENTAL

Caldonirimab combined with nimotuzumab therapy

Drug: Caldonirimab and Nimotuzumab

Interventions

Caldonirimab and Nimotuzumab DRUG

Subjects will receive caldonirimab (6mg/Kg, q2w) until disease progression or for a maximum of 12 months, and Nimotuzumab (400mg/time, q2w) for a total of 8 cycles

Caldonirimab and nimotuzumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Xi'an Jiaotong University: lead

Study Sites (1)

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

nimotuzumab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Zi Liu

  Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zi Liu, M.D

CONTACT

13630223132; liuzmail@163.com

Qiying Zhang, M.D

CONTACT

18984240901; qyzhang1989@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 4, 2022
• Study Start: November 1, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2025
• Last Updated: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)