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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
280
Beijing Cancer Hospital
Beijing, China
RECRUITINGPhase 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 2 years
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.
Time frame: Up to approximately 2 years
Time to response (TTR)
The time from cycle 1 day 1(C1D1) to the first recorded response assessed by investigator per Lugano 2014 criteria.
Time frame: 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.
Time frame: Up to approximately 2 years
Progression-free survival (PFS)
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The time from C1D1 until disease progression assessed by investigator or death due to any cause, whichever occurs first.
Time frame: Up to approximately 2 years
Overall survival (OS)
The time from C1D1 until death due to any cause.
Time frame: Up to approximately 2 years
Maximum concentration (Cmax)
The maximum concentration of the drug observed in the blood plasma after administration.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 2 years
Half-life (T1/2)
The time required for the plasma concentration of the drug to decrease by half.
Time frame: Up to approximately 2 years
Anti-drug antibody (ADA)
Number of subjects with detectable anti-drug antibodies.
Time frame: Up to approximately 2 years