A Phase 1a, Open-label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Initial Efficacy of IBI110 in Subjects With Advanced Malignant Tumors
Overview
- Phase
- Phase 1
- Intervention
- IBI110
- Conditions
- Advanced Malignancies
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Enrollment
- 268
- Locations
- 1
- Primary Endpoint
- Number of subjects with AEs and SAEs
- Status
- Recruiting
- 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 IBI110 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.
- •Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumors and lymphomas that are refractory to standard therapy, or for which no standard therapy exists.
- •Measurable disease according to RECIST Version 1.1 in solid tumor.
- •Subjects (women of child-bearing potential and males) must be willing to use viable contraception method that is deemed effective by the investigator throughout the treatment period and for at least three months following the last dose of study drug. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential.
Exclusion Criteria
- •Previous exposure to any anti-lag-3 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.
- •Immunosuppressive drugs were used within 4 weeks prior to the first administration of the study drug.
- •Medication requiring long-term systemic hormones or any other immunosuppression therapy.
- •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.
- •There were unrecovered toxicity (excluding hair loss or fatigue) according to NCI CTCAE v5.0 induced by previous antitumor therapy (24 weeks before the first dose of study), and there were unrecovered immune-related adverse events (irAE) associated with immunotherapy.
- •Previous immunotherapy, such as anti-PD-1 / anti-PD-L1 antibody or anti-CTLA4 antibody, was discontinued due to the presence of \> grade 3 irAE.
- •Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases, or leptomeningeal disease.
Arms & Interventions
Phase Ia Dose-Escalation Stage:IBI110
Participants will be treated with escalating doses of IBI110 to determine the MTD.
Intervention: IBI110
Phase Ia Expansion Stage:IBI110
Participants will be enrolled in the expansion stage to better characterize the safety, tolerability, PK variability, and preliminary efficacy of IBI110 in different cancer types.
Intervention: IBI110
Phase Ib Dose-Escalation Stage:IBI110+ Sintilimab
Participants will be treated with escalating doses of IBI110 in combination with a fixed dose of Sintilimab to determine the MTD.
Intervention: IBI110+ Sintilimab
Phase Ib Expansion Stage:IBI110+ Sintilimab
Participants will be enrolled in the expansion stage to better characterize the safety, tolerability, PK variability, and preliminary efficacy of IBI110 in combination with Sintilimab in different cancer types.
Intervention: IBI110+ 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 IBI110 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 IBI110 alone or in combination with Sintilimab.
Secondary Outcomes
- Immunogenicity: Percentage of ADA positive subjects(up to 2 years after enrollment)
- Preliminary anti-tumor activity of IBI110 (Objective Response Rate)(up to 2 years after enrollment)
- Pharmacokinetics: Cmax(up to 2 years after enrollment)
- Pharmacokinetics: AUC(up to 2 years after enrollment)