Beijing Cancer Hospital
Beijing, China
Location status: Recruiting
Location contact
Yuqin Song
CONTACT
NCT Number: NCT06642792
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Beijing, China
Location status: Recruiting
Yuqin Song
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects receive AK129 intravenously.
Subjects receive AK117 intravenously.
Time frame: Within the first 28 days following the first dose of study treatment.
Any untoward medical occurrence in a subject within the first 28 days following the first dose, considered related to the study treatment.
Time frame: Up to approximately 2 years.
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
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
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
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
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
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
The time from C1D1 until death due to any cause.
Time frame: Up to approximately 2 years
The maximum concentration of the drug observed in the blood plasma after administration.
Time frame: Up to approximately 2 years
The time taken to reach the maximum concentration (Cmax) of the drug in the blood plasma.
Time frame: Up to approximately 2 years
The area under the plasma concentration versus time curve, which represents the total drug exposure over time.
Time frame: Up to approximately 2 years
The time required for the plasma concentration of the drug to decrease by half.
Time frame: Up to approximately 2 years
Number of subjects with detectable anti-drug antibodies.
Contact information is provided by the study sponsor or research team.
Akeso
Industry
A Phase I/II Study of AK129 (Bispecific Antibody Targeting LAG-3 and PD-1) Monotherapy or in Combination With AK117 (Anti-CD47 Monoclonal Antibody) in Relapse or Refractory Classic Hodgkin Lymphoma With PD-1/L1 Inhibitor Treatment Failure
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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