A Phase 1a, Open-label, Dose-Escalation Study to Evaluate 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
Overview
- Phase
- Phase 1
- Intervention
- IBI939
- Conditions
- Advanced Malignancies
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Number of subjects with AEs and SAEs
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Able to understand and willing to sign the ICF.
- •Adults 18 years of age or older.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Life expectancy at least 12 weeks.
- •Adequate organ and bone marrow function.
- •Eligibility Criteria：
- •Previous exposure to any anti-TIGIT antibody.
- •Participate in another interventional clinical study, except for the observational (non-interventional) clinical study or the survival follow-up phase of the interventional study.
- •Any investigational drugs received within 4 weeks prior to the first study treatment.
- •Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy.
Exclusion Criteria
- Not provided
Arms & Interventions
Phase Ia Dose-Escalation Stage:IBI939
Participants will be treated with escalating doses of IBI939 to determine the MTD.
Intervention: IBI939
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.
Intervention: IBI939+ Sintilimab
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.
Intervention: IBI939+ Sintilimab
Outcomes
Primary Outcomes
Number of subjects with AEs and SAEs
Time Frame: 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)
Time Frame: From Baseline to the end of Cycle 1
To evaluate the safety and tolerability of IBI939 alone or in combination with Sintilimab.
Secondary Outcomes
- Pharmacokinetics: AUC(up to 2 years after enrollment)
- Pharmacokinetics: Cmax(up to 2 years after enrollment)
- Immunogenicity: Percentage of ADA positive subjects(up to 2 years after enrollment)
- Preliminary anti-tumor activity (Objective Response Rate)(up to 2 years after enrollment)