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

NCT04945421 | Completed Phase 1

• 1 other identifier: CIBI310F201
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• ORR(Objective response rate)

  Investigator evaluated ORR per RECIST V1.1

  Up to 2 years

Secondary Outcomes (9)

• DOR(Duration of Response)

  Up to 2 years

• PFS (Progress Free Survival)

  Up to 2 years

• OS (Overall Survival)

  Up to 2 years

• DCR(Disease control rate)

  Up to 2 years

• TTR(Time to progress)

  Up to 2 years

Study Arms (1)

Sintilimab and IBI310 (single arm)

EXPERIMENTAL

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.

Drug: Sintilimab; Drug: IBI310

Interventions

Sintilimab 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.

Sintilimab and IBI310 (single arm)

IBI310 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.

Sintilimab and IBI310 (single arm)

Eligibility Criteria

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

You may qualify if:

• Aged ≥18 years;
• ECOG 0 \~ 1;
• Histologically/cytologically confirmed R/M NPC;
• Failed to prior Anti-PD-1 resistance;
• Adequate organ and bone marrow function;
• Expected survival ≥12 weeks;
• 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;
• Subjects who sign the written informed consent form, and can abide by the visits and related procedures specified in the protocol.
• At least 1 measurable lesion according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST V1.1).

You may not qualify if:

• Had tumors other than NPC within the past 5 years.
• Had allogeneic organ or stem cell transplantation.
• The presence of uncontrolled life-threatening illness
• 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.
• Patients who have used large doses of glucocorticoids, anti-cancer monoclonal antibodies, and other immunosuppressive agents within 4 weeks.
• HIV positive.
• Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
• Severe, uncontrolled medical conditions and infections.
• At the same time using other test drugs or in other clinical trials.
• Refusal or inability to sign informed consent to participate in the trial.
• Other treatment contraindications.
• Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct.
• Hepatitis B surface antigen (HBsAg) positive and HBVDNA ≥1000cps/ml.
• Patients with positive HCV antibody test results can only be included in the study when the polymerase chain reaction of HCV RNA is negative.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Interventions

sintilimab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 30, 2021
• Study Start: July 23, 2021
• Primary Completion: April 25, 2022
• Study Completion: February 6, 2023
• Last Updated: February 23, 2023

Record last verified: 2023-02

Locations

CN (1)