Clinical trial · Interventional
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
NCT04353830CI-TRIAL-00064351completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IBI939 | Drug | — | UNRESOLVED |
| IBI939+ Sintilimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Phase Ia Dose-Escalation Stage:IBI939
- description
- Participants will be treated with escalating doses of IBI939 to determine the MTD.
- interventionNames
- Drug: IBI939
- type
- EXPERIMENTAL
- label
- Phase Ia Dose-Escalation Stage:IBI939+ Sintilimab
- description
- Participants will be treated with escalating doses of IBI939 in combination with a fixed dose of Sintilimab to determine the MTD.
- interventionNames
- Drug: IBI939+ Sintilimab
- type
- EXPERIMENTAL
- label
- Phase Ib Expansion Stage:IBI939+ Sintilimab
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.