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

Phase 1

Completed

• Conditions: Advanced Malignancies
• Interventions: Drug: IBI939+ Sintilimab; Drug: IBI939

• Registration Number: NCT04353830
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-17
• Study First Submitted QC: 2020-04-17
• Study First Posted: 2020-04-20
• Study Start: 2020-05-22
• Primary Completion: 2022-05-11
• Study Completion: 2022-05-11
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase Ia Dose-Escalation Stage:IBI939+ Sintilimab	IBI939+ Sintilimab	Participants will be treated with escalating doses of IBI939 in combination with a fixed dose of Sintilimab to determine the MTD.
Phase Ib Expansion Stage:IBI939+ Sintilimab	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.
Phase Ia Dose-Escalation Stage:IBI939	IBI939	Participants will be treated with escalating doses of IBI939 to determine the MTD.

Primary Outcome Measures

Name	Time	Method
Number of subjects with AEs and SAEs	up to 2 years after enrollment	To evaluate the safety and tolerability of IBI939 alone or in combination with Sintilimab \[Adverse events (AEs), Serious Adverse Events (SAEs) \]
Percentage of Participants with Dose-Limiting Toxicities (DLTs)	From Baseline to the end of Cycle 1	To evaluate the safety and tolerability of IBI939 alone or in combination with Sintilimab.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics: AUC	up to 2 years after enrollment	The area under the curve (AUC) of serum concentration of the drug after the administration.
Pharmacokinetics: Cmax	up to 2 years after enrollment	Maximum concentration (Cmax) of the drug after administration
Immunogenicity: Percentage of ADA positive subjects	up to 2 years after enrollment	Immunogenicity: Number of Anti-Drug Antibodies (ADA) positive subjects will be counted and percentage of ADA positive subjects will be calculated to evaluate immunogenicity of IBI939.
Preliminary anti-tumor activity (Objective Response Rate)	up to 2 years after enrollment	Objective Response Rate (ORR) is the percentage of Complete Response (CR) plus partial response (PR) assessed by RECIST v1.1 criteria for solid tumors.

Trial Locations

Locations (1)

Peking University Cancer Hospital & Institute; 🇨🇳 Beijing, China