IBI310 in Combination With Siltilimab in Subjects With Anti-PD-1/PD-L1 Resistance R/M NPC

NCT ID: NCT04945421

Last Updated: 2023-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-23
• Study Completion Date: 2023-02-06

Brief Summary

This is a phase 1b/II, open label, multicenter study of IBI310 (Anti-CTLA4 mAb) in combination with Sintilimab in patients with recurrent/metastatic Nasopharyngeal Carcinoma that failed prior Anti-PD-1/PD-L1 therapy

Conditions

NPC

Study Design

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

Study Groups

Sintilimab and IBI310 (single arm)

The test group will be treated with either (IBI310 3 mg/kg IV d1, Q3W combined with sintilimab 100 mg IV d1, Q3W) or( IBI310 1 mg/kg IV d1, Q3W combined with sintilimab 200 mg IV d1, Q3W) for up to 4 cycles, and then sintilimab 200 mg IV d1, Q3W until progressive disease, intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.

Group Type: EXPERIMENTAL

Sintilimab

Intervention Type: DRUG

(IBI310 3 mg/kg IV d1, Q3W combined with sintilimab 100 mg IV d1, Q3W) or( IBI310 1 mg/kg IV d1, Q3W combined with sintilimab 200 mg IV d1, Q3W) for up to 4 cycles, and then sintilimab 200 mg IV d1, Q3W until progressive disease, intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.

IBI310

Intervention Type: DRUG

(IBI310 3 mg/kg IV d1, Q3W combined with sintilimab 100 mg IV d1, Q3W) or( IBI310 1 mg/kg IV d1, Q3W combined with sintilimab 200 mg IV d1, Q3W) for up to 4 cycles, and then sintilimab 200 mg IV d1, Q3W until progressive disease, intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.

Interventions

Sintilimab

(IBI310 3 mg/kg IV d1, Q3W combined with sintilimab 100 mg IV d1, Q3W) or( IBI310 1 mg/kg IV d1, Q3W combined with sintilimab 200 mg IV d1, Q3W) for up to 4 cycles, and then sintilimab 200 mg IV d1, Q3W until progressive disease, intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.

Intervention Type: DRUG

IBI310

(IBI310 3 mg/kg IV d1, Q3W combined with sintilimab 100 mg IV d1, Q3W) or( IBI310 1 mg/kg IV d1, Q3W combined with sintilimab 200 mg IV d1, Q3W) for up to 4 cycles, and then sintilimab 200 mg IV d1, Q3W until progressive disease, intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Aged ≥18 years;

2. ECOG 0 ~ 1;

3. Histologically/cytologically confirmed R/M NPC;

4. Failed to prior Anti-PD-1 resistance;

5. Adequate organ and bone marrow function;

6. Expected survival ≥12 weeks;

7. Female subjects of childbearing age or male patients whose sex partners are women of childbearing age should take effective contraceptive measures throughout the treatment period and within 6 months after the last administration;

8. Subjects who sign the written informed consent form, and can abide by the visits and related procedures specified in the protocol.

9. At least 1 measurable lesion according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST V1.1).

Exclusion Criteria

1. Had tumors other than NPC within the past 5 years.

2. Had allogeneic organ or stem cell transplantation.

3. The presence of uncontrolled life-threatening illness

4. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.

5. Patients who have used large doses of glucocorticoids, anti-cancer monoclonal antibodies, and other immunosuppressive agents within 4 weeks.

6. HIV positive.

7. Patients with significantly lower heart, liver, lung, kidney and bone marrow function.

8. Severe, uncontrolled medical conditions and infections.

9. At the same time using other test drugs or in other clinical trials.

10. Refusal or inability to sign informed consent to participate in the trial.

11. Other treatment contraindications.

12. Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct.

13. Hepatitis B surface antigen (HBsAg) positive and HBVDNA ≥1000cps/ml.

14. Patients with positive HCV antibody test results can only be included in the study when the polymerase chain reaction of HCV RNA is negative.

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

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

CIBI310F201

Identifier Type: -

Identifier Source: org_study_id