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

NCT04353830 | Completed Phase 1 DMC

• 1 other identifier: CIBI939A101
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Number of subjects with AEs and SAEs

  To evaluate the safety and tolerability of IBI939 alone or in combination with Sintilimab \[Adverse events (AEs), Serious Adverse Events (SAEs) \]

  up to 2 years after enrollment

• Percentage of Participants with Dose-Limiting Toxicities (DLTs)

  To evaluate the safety and tolerability of IBI939 alone or in combination with Sintilimab.

  From Baseline to the end of Cycle 1

Secondary Outcomes (4)

• 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

Study Arms (3)

Phase Ia Dose-Escalation Stage:IBI939

EXPERIMENTAL

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

Drug: IBI939

Phase Ia Dose-Escalation Stage:IBI939+ Sintilimab

EXPERIMENTAL

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

Drug: IBI939+ Sintilimab

Phase Ib Expansion Stage:IBI939+ Sintilimab

EXPERIMENTAL

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.

Drug: IBI939+ Sintilimab

Interventions

IBI939 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

IBI939+ Sintilimab 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 Ia Dose-Escalation Stage:IBI939+ Sintilimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 1.
• 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.
• 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.
• Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases, or leptomeningeal disease.
• History of autoimmune disease , present active autoimmune disease or inflammatory diseases

Sponsors & Collaborators

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

Study Sites (1)

Peking University Cancer Hospital & Institute

Beijing, China

Location

Study Design

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

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 20, 2020
• Study Start: May 22, 2020
• Primary Completion: May 11, 2022
• Study Completion: May 11, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

CN (1)