Cadonilimab in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma

NCT ID: NCT05898256

Last Updated: 2023-06-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2026-07-31

Brief Summary

This study is a single-arm, multicenter clinical study to evaluate the efficacy and safety of Cadonilimab in combination with gemcitabine/cisplatin as a first-line treatment for recurrent or metastatic nasopharyngeal carcinoma.

Conditions

Nasopharyngeal Carcinoma; Immune Checkpoint Inhibitors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bispecific Antibody + GP Group

Cadonilimab will be administered once every 3 weeks (Q3W), for up to 2 years；

Gemcitabine on Day 1, Day 8 of each 3 weeks cycle, for 4 to 6 cycles；

Cisplatin on Day 1 of each 3 weeks cycle, for 4 to 6 cycles.

Group Type: EXPERIMENTAL

Cadonilimab

Intervention Type: DRUG

10mg/kg administered intravenously (IV)

Gemcitabine

Intervention Type: DRUG

1 g/m2, administered as an IV infusion within 30 minutes

Cisplatin

Intervention Type: DRUG

80 mg/m2, administered as an IV infusion over 4 hours

Interventions

Cadonilimab

10mg/kg administered intravenously (IV)

Intervention Type: DRUG

Gemcitabine

1 g/m2, administered as an IV infusion within 30 minutes

Intervention Type: DRUG

Cisplatin

80 mg/m2, administered as an IV infusion over 4 hours

Intervention Type: DRUG

Other Intervention Names

AK104

Eligibility Criteria

Inclusion Criteria

1. The subject must sign the written informed consent form (ICF) voluntarily；

2. Age ≥18 years and ≤65 years；

3. Subjects with histopathological diagnosis of nasopharyngeal carcinoma；

4. Primarily metastatic (stage IVB as defined by AJCC staging system for NPC, eighth edition) or recurrent/metastatic NPC that is not amenable to local regional treatment or curative treatment and at least 6 months after radical treatment；

5. Has not received prior systemic treatment;

6. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status

7. Subject must have a measurable target lesion based on RECIST v1.1;

Exclusion Criteria

1. Allergic to monoclonal antibodies, any cadonilimab components, gemcitabine, cisplatin, and other platinum drugs;

2. Prior therapy as follow:

Anti-PD-1, anti-PD-L1 or anti-CTLA-4; Concurrent medical condition requiring the use of cortisol (>10mg/day Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment（Except：inhalation or topical corticosteroids）.

3. Any active malignancy ≤ 2 years before randomization except for specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)；

4. Female patients who are at pregnancy or lactation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangxi Medical University

OTHER

Sponsor Role: lead

Responsible Party

Kai Hu

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

kai hu, professor

Role: CONTACT

gxhukai@hotmail.com

+867715356509

Other Identifiers

GuangxiMUHK4

Identifier Type: -

Identifier Source: org_study_id