Clinical trial · Interventional
The Primary Objective of This Study to Evaluate the Safety and Tolerability of IBI334 and Determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D)and Anti Tumor Activity of IBI334.
A Phase I/II Study of IBI334 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
NCT05774873CI-TRIAL-00100211completedPhase 1 / Phase 2ClinicalTrials.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 I/II study is designed to evaluate the Safety and tolerability and Efficacy of IBI334 Monotherapy 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 |
|---|---|---|---|
| IBI334 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IBI334 in advanced solid tumors
- interventionNames
- Drug: IBI334
Primary outcomes (2)
- measure
- Number of patients with treatment-related adverse events
- timeFrame
- Up to 60 days post last dose
- measure
- Percentage of subjects woth Dose-Limitine toxicities(DLTs)
- timeFrame
- Up to 28 days following first dose
Secondary outcomes (12)
- measure
- PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: area under the curve (AUC)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol; 2. Male or female subjects ≥ 18 years old; 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1; 4. Anticipated life expectancy of ≥ 12 weeks; 5. At least 1 evaluable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1with Phase Ia ;At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 with Phase Ib+II; Exclusion Criteria: 1. Participate in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of the interventional study; 2. Received live vaccines within 4 weeks prior to first dose of the study drug or plan on receiving any live vaccine during the study; 3. History of immunodeficiency disease, including congenital or acquired immunodeficiency diseases; 4. Severe allergic or hypersensitive to other EGFR or B7H3 antibodies or any ingredients of IBI334; 5. Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief, which must not affect tumor assessment throughout the study;
References
Publications (1)
- DERIVEDGuan J, Chia T, Li B, Zhu T, Liao Z, Deng J, Fu F, Wu W, Liu C, Liu Y, Li N, Yue L, Cao L, Lu J, Zhu M, Ling X, Zheng H, Lin S, Li L, Zhou S, He K. B7-H3-mediated cis-inhibition of EGFR by a tumor-selective bispecific antibody enhances anti-tumor efficacy and minimizes toxicities. Nat Commun. 2026 Feb 24;17(1):3113. doi: 10.1038/s41467-026-69703-7. PMID 41735305