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The purpose of this study will be to evaluate the safety, tolerability, and inital efficacy of HBT-708 in subjects with advanced solid tumors.
This study is a study of HBT-708 monotherapy in advanced solid tumors. This study includes dose-escalation and dose-expansion cohort, with the accelerated titration combined 3+3 dose escalation method. The administration frequencies of HBT-708 is Q3W i.v. All cohorts will assess the efficacy and safety of the preset several dose levels of HBT-708 in advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Dose escalation will be conducted using an accelerated titration plus traditional 3+3 design. Dose Escalation includes 7 levels, Q3W IV. Dose extension will be carried out at the selected level. dose level 1 of HBT-708 Q3W i.v. |
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| Arm 2 | Experimental | Dose escalation will be conducted using an accelerated titration plus traditional 3+3 design. Dose Escalation includes 7 levels, Q3W IV. Dose extension will be carried out at the selected level. dose level 2 of HBT-708 Q3W i.v. |
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| Arm 3 | Experimental | Dose escalation will be conducted using an accelerated titration plus traditional 3+3 design. Dose Escalation includes 7 levels, Q3W IV. Dose extension will be carried out at the selected level. dose level 3 of HBT-708 Q3W i.v. |
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| Arm 4 | Experimental | Dose escalation will be conducted using an accelerated titration plus traditional 3+3 design. Dose Escalation includes 7 levels, Q3W IV. Dose extension will be carried out at the selected level. dose level 4 of HBT-708 Q3W i.v. |
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| Arm 5 | Experimental | Dose escalation will be conducted using an accelerated titration plus traditional 3+3 design. Dose Escalation includes 7 levels, Q3W IV. Dose extension will be carried out at the selected level. dose level 5 of HBT-708 Q3W i.v. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HBT-708 | Drug | bispecific antibody |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with any treatment-emergent adverse event (TEAE) and dose-limiting toxicities | Adverse event were defined as the appearance of undesirable signs, symptoms, or medical conditions that occurred after informed consent. | up to 24 months (every cycle visit, each cycle is 21 days) |
| Determine the maximum tolerated dose (MTD) and the maximum administration dose | Adverse events were defined as the appearance of undesirable signs, symptoms, or medical conditions that occurred after a participant provided informed consent. | up to 24 months (every cycle visit, each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| the plasma concentration of HBT-708 | PK parameters will be calculated from the blood plasma concentrations of HBT-708 using standard noncompartmental PK methods. | Cycle1Day1, Cycle1Day2, Cycle1Day4, Cycle1Day8, Cycle1Day15; Cycle2 Day1; Cycle3 Day1, Cycle3Day2, Cycle3Day4, Cycle3Day8, Cycle3Day15; then Day 1 of every 2 cycles ( each cycle is 21 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| Arm 6 | Experimental | Dose escalation will be conducted using an accelerated titration plus traditional 3+3 design. Dose Escalation includes 7 levels, Q3W IV. Dose extension will be carried out at the selected level. dose level 6 of HBT-708 Q3W i.v. |
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| Arm 7 | Experimental | Dose escalation will be conducted using an accelerated titration plus traditional 3+3 design. Dose Escalation includes 7 levels, Q3W IV. Dose extension will be carried out at the selected level. dose level 7 of HBT-708 Q3W i.v. |
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