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This is a phase I/IIa study to evaluate the safety, tolerability and efficacy of IBC0966 for the treatment of subjects with advanced malignant tumors.
The study includes three phases: dose escalation (Phase Ia), dose extension (Phase Ib), and clinical exploration (Phase IIa).
First, the Phase Ia dose escalation will be carried out. After switching to the 3+3 escalation mode, the Phase Ib dose extension study can be carried out at the same time. After Phase Ia is completed and RP2D is obtained, Phase IIa clinical exploratory research can be carried out.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase Ia - Dose escalation(Acceleration Stage) | Experimental | Phase Ia is an open, non-random, single-arm dose escalation design. Acceleration Stage: The initial increasing dose is 0.025 mg/kg, and the dose is increased in 100% increments. Each dose group will enroll 1 subject. |
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| Phase Ia - Dose escalation(3+3 Stage) | Experimental | Phase Ia is an open, non-random, single-arm dose escalation design. 3+3 Stage: The dose is increased in 30%-50% increments between adjacent dose groups, and the increment is determined by the investigator and the sponsor based on the safety data obtained in the previous period.Each dose group will enroll 3 to 6 evaluable subjects (evaluable: at least complete the DLT observation period), and this period continues until the maximum tolerated dose (MTD) is reached. |
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| Phase Ib - Dose extension | Experimental | Phase Ib is an open, non-random, single-arm, multi-center research design. When phase Ia is transformed into 3+3 stage, a certain dose group meets the conditions for increasing the next dose group (after the DLT observation period of the last subject in the dose group has passed, the safety assessment of the current dose group will be completed) , The dose extension study of this dose group can be carried out, and 6 evaluable (evaluable: at least 2 cycles of dosing and observation) subjects with advanced malignant tumors who have failed standard treatments will be included in this dose group. |
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| Phase IIa - Clinical Exploratory Stage(Group A) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBC0966 | Biological | IBC0966 is an investigational product. |
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| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events (AEs) and SAEs (Phase Ⅰ) | To investigate the safety characteristics. | 3 months after end event visit |
| Dose limiting toxicities (DLTs) (Phase Ⅰ) | To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). | 28 days after first dose |
| Objective response rate (ORR) in dose expansion (Phase Ⅱa) | To explore the clinical effectiveness. Tumor response based on RECIST 1.1 or Lugano 2014. | Baseline through up to 2 years or until disease progression |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Cmax (Phase Ⅰ) | PK parameters (Cmax) following single dose. | Day1,2,3,7,14,21, 28 of DLT observation period , Day1of each subsequent cycle (each cycle is 7 days), and at the End of Treatment visit, up to about 2 years |
| Pharmacokinetic (PK) Tmax (Phase Ⅰ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| tie xu | Contact | 18036618680 | 18036618680@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Qingyuan Zhang | The Affiliated Tumor Hospital of Harbin Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Tumor Hospital of Harbin Medical University | Recruiting | Harbin | Heilongjiang | 150081 | China |
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The Phase IIa is planned to be divided into four indication groups, all of which are open, non-randomized, two-stage, single-arm research design. Group A: Recurrent or metastatic triple-negative breast cancer that failed standard treatment. |
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| Phase IIa - Clinical Exploratory Stage(Group B) | Experimental | The Phase IIa is planned to be divided into four indication groups, all of which are open, non-randomized, two-stage, single-arm research design. Group B: Locally advanced/metastatic non-small cell lung cancer without driver gene mutations that failed standard treatment. |
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| Phase IIa - Clinical Exploratory Stage(Group C) | Experimental | The Phase IIa is planned to be divided into four indication groups, all of which are open, non-randomized, two-stage, single-arm research design. Group C: Recurrent or metastatic head and neck squamous cell carcinoma that failed standard treatment. |
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| Phase IIa - Clinical Exploratory Stage(Group D) | Experimental | The Phase IIa is planned to be divided into four indication groups, all of which are open, non-randomized, two-stage, single-arm research design. Group D: Recurrent or metastatic peripheral T-cell lymphoma that failed standard treatment. |
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PK parameters (Tmax) following single dose. |
| Day1,2,3,7,14,21, 28 of DLT observation period , Day1of each subsequent cycle (each cycle is 7 days), and at the End of Treatment visit, up to about 2 years |
| Pharmacokinetic (PK) AUC 0-t (Phase Ⅰ) | PK parameters (AUC 0-t ) following single dose. | Day1,2,3,7,14,21, 28 of DLT observation period , Day1of each subsequent cycle (each cycle is 7 days), and at the End of Treatment visit, up to about 2 years |
| Pharmacokinetic (PK) AUC 0-∞ (Phase Ⅰ) | PK parameters (AUC 0-∞) following single dose. | Day1,2,3,7,14,21, 28 of DLT observation period , Day1of each subsequent cycle (each cycle is 7 days), and at the End of Treatment visit, up to about 2 years |
| Pharmacokinetic (PK) t1/2 (Phase Ⅰ) | PK parameters (t1/2) following single dose. | Day1,2,3,7,14,21, 28 of DLT observation period , Day1of each subsequent cycle (each cycle is 7 days), and at the End of Treatment visit, up to about 2 years |
| Pharmacokinetic (PK) λz (Phase Ⅰ) | PK parameters (λz) following single dose. | Day1,2,3,7,14,21, 28 of DLT observation period , Day1of each subsequent cycle (each cycle is 7 days), and at the End of Treatment visit, up to about 2 years |
| Pharmacokinetic (PK) Css,max (Phase Ⅰ) | PK parameters (Css,max) following single dose. | Day1,2,3,7,14,21, 28 of DLT observation period , Day1of each subsequent cycle (each cycle is 7 days), and at the End of Treatment visit, up to about 2 years |
| Pharmacokinetic (PK) Css,min (Phase Ⅰ) | PK parameters (Css,min) following single dose. | Day1,2,3,7,14,21, 28 of DLT observation period , Day1of each subsequent cycle (each cycle is 7 days), and at the End of Treatment visit, up to about 2 years |
| Pharmacokinetic (PK) AUCss (Phase Ⅰ) | PK parameters (AUCss) following single dose. | Day1,2,3,7,14,21, 28 of DLT observation period , Day1of each subsequent cycle (each cycle is 7 days), and at the End of Treatment visit, up to about 2 years |
| Objective response rate (ORR) in dose escalation (Phase Ⅰ) | Tumor response based on RECIST 1.1 or Lugano 2014. | Baseline through up to 2 years or until disease progression |
| Incidence of adverse events (AEs) and SAEs (Phase Ⅰ) | To investigate the safety characteristics. | 3 months after end event visit |
| Immunogenicity of IBC0966 (Phase Ⅰ) | The frequency of anti-drug antibodies (ADA) against IBC0966.(Phase Ⅰ) | 3 months after end event visit |
| Progression free survival (PFS) (Phase Ⅱa) | PFS as assessed using RECIST 1.1 or Lugano 2014. | Baseline through up to 2 years or until disease progression |
| Overall survival (OS) (Phase Ⅱa) | OS as assessed using RECIST 1.1 or Lugano 2014. | Baseline through up to 2 years or until disease progression |
| Disease control rate (DCR) (Phase Ⅱa) | DCR as assessed using RECIST 1.1 or Lugano 2014. | Baseline through up to 2 years or until disease progression |
| Incidence of adverse events (AEs) and SAEs (Phase Ⅱa) | To investigate the safety characteristics. | 3 months after end event visit |
| Immunogenicity of IBC0966 (Phase Ⅱa) | The frequency of anti-drug antibodies (ADA) against IBC0966.(Phase Ⅱa) | 3 months after end event visit |