Clinical trial · Interventional
A Phase Ib Study of Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors
A Phase Ib, Open-Label, Multi-Center, Study of Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors
NCT05172856CI-TRIAL-00055717unknownPhase 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 open-label, multicenter, Phase Ib study is designed to evaluate the Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in participants with advanced solid tumors.
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 Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IBI321 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IBI321 in advanced solid tumors
- interventionNames
- Drug: IBI321
Primary outcomes (1)
- measure
- Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators.
- timeFrame
- From Baseline until disease progression (up to 2 years)
Secondary outcomes (9)
- measure
- Progression Free Survival (PFS), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators.
- timeFrame
- From Baseline until disease progression (up to 2 years)
- measure
- Overall Survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures. 2. Male or female subjects ≥18 years and ≤75 years. 3. At least one measurable lesion per RECIST version 1.1 4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1 5. Life expectancy of ≥ 12 weeks. 6. Adequate hematologic and end organ function Exclusion Criteria: 1. Failure to recover from adverse events from the most recent anti-tumor treatments 2. Acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection. 3. Subjects with CNS metastasis unless they are asymptomatic or adequately treated with radiotherapy and/or surgery and subjects are neurologically stable with minimal residual symptoms/signs. 4. Any other serious underlying medical (e.g., uncontrolled hypertension, active uncontrolled infection, active gastric ulcer,uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, other serious cardiac conditions not listed in exclusion criteria), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications. 5. Pregnancy, lactation, breastfeeding. 6. Previous exposure to any anti-TIGIT antibody, or recombinant protein.
References
Publications (0)
Data not yet available
No reference posted for this study.