A Study Evaluating the Safety, Tolerability, and Initial Efficacy of Recombinant Human Anti-T-cell Immunoreceptor With Ig and ITIM Domains (TIGIT) Monoclonal Antibody Injection (IBI939) in Subjects With Advanced Malignant Tumors

NCT ID: NCT04353830

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-22
• Study Completion Date: 2022-05-11

Brief Summary

This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of IBI939 in subjects with advanced malignancies

Conditions

Advanced Malignancies

Study Design

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

Study Groups

Phase Ia Dose-Escalation Stage:IBI939

Participants will be treated with escalating doses of IBI939 to determine the MTD.

Group Type: EXPERIMENTAL

IBI939

Intervention Type: DRUG

Several dose levels will be evaluated for IBI939 administered as a single agent and in combination with Sintilimab. IBI939 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit. Those who discontinue treatment with single-agent IBI939 may receive combination treatment with Sintilimab or IBI939+ Sintilimab. Combination treatment may continue until disease progression or loss of clinical benefit.

Phase Ia Dose-Escalation Stage:IBI939+ Sintilimab

Participants will be treated with escalating doses of IBI939 in combination with a fixed dose of Sintilimab to determine the MTD.

Group Type: EXPERIMENTAL

IBI939+ Sintilimab

Intervention Type: DRUG

IBI939: Several dose levels will be evaluated for IBI939 in combination with Sintilimab. IBI939 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit.

Sintilimab: Sintilimab will be given as 200 mg via IV infusion on Day 1 of each 21-day cycle in combination with IBI939. Combination treatment may continue until disease progression or loss of clinical benefit.

Phase Ib Expansion Stage:IBI939+ Sintilimab

Participants will be enrolled in the expansion stage to better characterize the safety, tolerability, PK variability, and preliminary efficacy of IBI939 in combination with Sintilimab in different cancer types.

Group Type: EXPERIMENTAL

IBI939+ Sintilimab

Intervention Type: DRUG

IBI939: IBI939 in combination with Sintilimab will be given with RP2D. IBI939 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit.

Sintilimab: Sintilimab will be given as 200 mg via IV infusion on Day 1 of each 21-day cycle in combination with IBI939. Combination treatment may continue until disease progression or loss of clinical benefit.

Interventions

IBI939

Several dose levels will be evaluated for IBI939 administered as a single agent and in combination with Sintilimab. IBI939 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit. Those who discontinue treatment with single-agent IBI939 may receive combination treatment with Sintilimab or IBI939+ Sintilimab. Combination treatment may continue until disease progression or loss of clinical benefit.

Intervention Type: DRUG

IBI939+ Sintilimab

IBI939: Several dose levels will be evaluated for IBI939 in combination with Sintilimab. IBI939 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit.

Sintilimab: Sintilimab will be given as 200 mg via IV infusion on Day 1 of each 21-day cycle in combination with IBI939. Combination treatment may continue until disease progression or loss of clinical benefit.

Intervention Type: DRUG

IBI939+ Sintilimab

IBI939: IBI939 in combination with Sintilimab will be given with RP2D. IBI939 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit.

Sintilimab: Sintilimab will be given as 200 mg via IV infusion on Day 1 of each 21-day cycle in combination with IBI939. Combination treatment may continue until disease progression or loss of clinical benefit.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Able to understand and willing to sign the ICF.

2. Adults 18 years of age or older.

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

4. Life expectancy at least 12 weeks.

5. Adequate organ and bone marrow function.

Eligibility Criteria：

1. Previous exposure to any anti-TIGIT antibody.

2. Participate in another interventional clinical study, except for the observational (non-interventional) clinical study or the survival follow-up phase of the interventional study.

3. Any investigational drugs received within 4 weeks prior to the first study treatment.

4. Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy.

5. Immunosuppressive drugs were used within 4 weeks prior to the first administration of the study drug.

6. Medication requiring long-term systemic hormones or any other immunosuppression therapy.

7. Major surgical procedures (craniotomy, thoracotomy, or laparotomy) or unhealed wounds, ulcers, or fractures were performed within 4 weeks prior to the first dose of study therapy.

8. Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases, or leptomeningeal disease.

9. History of autoimmune disease , present active autoimmune disease or inflammatory diseases

10. Positive human immunodeficiency virus (HIV) test.

11. Active hepatitis B or C, or tuberculosis.

12. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.

13. Known history of hypersensitivity to any components of the IBI939 or Sintilimab.

14. Pregnant or nursing females.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University Cancer Hospital & Institute

Beijing, , China

Countries

China

Other Identifiers

CIBI939A101

Identifier Type: -

Identifier Source: org_study_id