Clinical trial · Interventional
Efficacy and Safety of Caldonirimab Plus Nimotuzumab for Recurrent or Metastatic Cervical Cancer
Efficacy and Safety of Caldonirimab Plus Nimotuzumab for Recurrent or Metastatic Cervical Cancer: a Multicenter, Single-arm, Prospective Phase II Trial
NCT05606263CI-TRIAL-00066739GCR-05unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluated the efficacy and safety of caldonirimab plus nimotuzumab as second-line or later therapy for recurrent or metastatic cervical cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Caldonirimab and Nimotuzumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Caldonirimab and nimotuzumab
- description
- Caldonirimab combined with nimotuzumab therapy
- interventionNames
- Drug: Caldonirimab and Nimotuzumab
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- 2 years
- description
- ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1
Secondary outcomes (4)
- measure
- Disease control rate (DCR)
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.