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This is a phase I/II study. All subjects are patients diagnosed with relapse or refractory (R/R) classic Hodgkin lymphoma (cHL) and has progressed on treatment with PD-1/L1 inhibitor therapy. The purpose of this study is to evaluate the safety and efficacy of AK129 (bispecific antibody targeting LAG-3 and PD-1) monotherapy or in combination with AK117 (anti-CD47 monoclonal antibody) in R/R cHL with PD-1/L1 inhibitor treatment failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK129 | Experimental | Phase Ia: Subjects will receive AK129: different doses on every 2 weeks. |
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| AK129+AK117 | Experimental | Phase Ib: Subjects will receive: AK129: different doses on every 2 weeks, AK117: 30mg/kg on every 2 weeks. Phase II: Subjects will receive: AK129: recommended phase II dose (RP2D) from phase Ib on every 2 weeks, AK117: 30mg/kg on every 2 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK129 | Drug | Subjects receive AK129 intravenously. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Number of participants with dose limiting toxicity (DLT) | Any untoward medical occurrence in a subject within the first 28 days following the first dose, considered related to the study treatment. | Within the first 28 days following the first dose of study treatment. |
| Phase I/II: Incidence and severity of adverse events (AEs) | Any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment. | Up to approximately 2 years. |
| Phase I/II: Objective response rate (ORR) | The proportion of subjects achieving complete response (CR) or partial response (PR) assessed by investigator per Lugano 2014 criteria. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | The proportion of subjects achieving complete response (CR) , partial response (PR) or stable disease (SD) assessed by investigator per Lugano 2014 criteria. | Up to approximately 2 years |
| Time to response (TTR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenting Li, MD | Contact | +86(0760)89873999 | clinicaltrials@akesobio.com |
| Name | Affiliation | Role |
|---|---|---|
| Wenting Li, MD | Akeso | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | China |
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| AK117 |
| Drug |
Subjects receive AK117 intravenously. |
|
The time from cycle 1 day 1(C1D1) to the first recorded response assessed by investigator per Lugano 2014 criteria.
| Up to approximately 2 years |
| Duration of response (DoR) | The time from the first recorded response until disease progression assessed by investigator or death due to any cause, whichever occurs first. | Up to approximately 2 years |
| Progression-free survival (PFS) | The time from C1D1 until disease progression assessed by investigator or death due to any cause, whichever occurs first. | Up to approximately 2 years |
| Overall survival (OS) | The time from C1D1 until death due to any cause. | Up to approximately 2 years |
| Maximum concentration (Cmax) | The maximum concentration of the drug observed in the blood plasma after administration. | Up to approximately 2 years |
| Time to maximum concentration (Tmax) | The time taken to reach the maximum concentration (Cmax) of the drug in the blood plasma. | Up to approximately 2 years |
| Area under the curve (AUC) | The area under the plasma concentration versus time curve, which represents the total drug exposure over time. | Up to approximately 2 years |
| Half-life (T1/2) | The time required for the plasma concentration of the drug to decrease by half. | Up to approximately 2 years |
| Anti-drug antibody (ADA) | Number of subjects with detectable anti-drug antibodies. | Up to approximately 2 years |