Clinical trial NCT04353830: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Malignancies
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-04-20
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Number of subjects with AEs and SAEs
timeFrame: up to 2 years after enrollment
measure: Percentage of Participants with Dose-Limiting Toxicities (DLTs)
timeFrame: From Baseline to the end of Cycle 1
Secondary outcomes:
measure: Pharmacokinetics: AUC
timeFrame: up to 2 years after enrollment
measure: Pharmacokinetics: Cmax
timeFrame: up to 2 years after enrollment
measure: Immunogenicity: Percentage of ADA positive subjects
timeFrame: up to 2 years after enrollment
measure: Preliminary anti-tumor activity (Objective Response Rate)
timeFrame: up to 2 years after enrollment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital & Institute
Study officials:
References: