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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI334 in advanced solid tumors | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI334 | Drug | There are six dose of IBI334 ,QW IV in first cycle and Q2W IV behind the first cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with treatment-related adverse events | Up to 60 days post last dose | |
| Percentage of subjects woth Dose-Limitine toxicities(DLTs) | Up to 28 days following first dose |
| Measure | Description | Time Frame |
|---|---|---|
| PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: area under the curve (AUC) | Day 1 up to treatment duration reaches 24 months | |
| PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to:maximum concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Cancer Hospital of Shandong First Medical university | Jinan | Shandong | 250117 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41735305 | Derived | Guan 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. |
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| Day 1 up to treatment duration reaches 24 months |
| PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: clearance (CL) | Day 1 up to treatment duration reaches 24 months |
| PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: apparent volume of distribution (V) | Day 1 up to treatment duration reaches 24 months |
| PK profile: major PK parameters of single and multiple doses of drugs, including but not limited to: half-life (t1/2). | Day 1 up to treatment duration reaches 24 months |
| Prevalence and incidence of anti-IBI334 antibodies. | Day 1 up to treatment duration reaches 24 months |
| Preliminary efficacy : objective response rate (ORR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria | Day 1 up to treatment duration reaches 24 months |
| Preliminary efficacy : duration of response (DoR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria | Day 1 up to treatment duration reaches 24 months |
| Preliminary efficacy : disease control rate (DCR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria | Day 1 up to treatment duration reaches 24 months |
| Preliminary efficacy :time to response (TTR) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria | Day 1 up to treatment duration reaches 24 months |
| Preliminary efficacy :progression-free survival (PFS) as evaluated per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria | Day 1 up to treatment duration reaches 24 months |
| Preliminary efficacy :overall survival (OS) | Day 1 up to treatment duration reaches 24 months |