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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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04353830
Enrollment
34
Registered
2020-04-20
Start date
2020-05-22
Completion date
2022-05-11
Last updated
2023-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Malignancies

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

Interventions

DRUGIBI939

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.

DRUGIBI939+ 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.

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of subjects with AEs and SAEsup to 2 years after enrollmentTo 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 1To evaluate the safety and tolerability of IBI939 alone or in combination with Sintilimab.

Secondary

MeasureTime frameDescription
Pharmacokinetics: AUCup to 2 years after enrollmentThe area under the curve (AUC) of serum concentration of the drug after the administration.
Pharmacokinetics: Cmaxup to 2 years after enrollmentMaximum concentration (Cmax) of the drug after administration
Immunogenicity: Percentage of ADA positive subjectsup to 2 years after enrollmentImmunogenicity: 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 enrollmentObjective Response Rate (ORR) is the percentage of Complete Response (CR) plus partial response (PR) assessed by RECIST v1.1 criteria for solid tumors.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026