Status:
COMPLETED
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
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Advanced Malignancies
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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 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
- Positive human immunodeficiency virus (HIV) test.
- Active hepatitis B or C, or tuberculosis.
- History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- Known history of hypersensitivity to any components of the IBI939 or Sintilimab.
- Pregnant or nursing females.
Exclusion
Key Trial Info
Start Date :
May 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2022
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04353830
Start Date
May 22 2020
End Date
May 11 2022
Last Update
March 1 2023
Active Locations (1)
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1
Peking University Cancer Hospital & Institute
Beijing, China