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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years old at the time of enrolment.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Expected Survival of ≥ 12 weeks.

• Diagnosed as R/R cHL according to Lugano 2014 criteria.

• Has progressed on treatment with PD-1/L1 inhibitior therapy.

• Has adequate organ function.

• All female and male subjects of reproductive potential must agree to use an effective method of contraception from the start of screening until 120 days after the last dose of study treatment.

Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
Contact Information
Primary
Wenting Li, MD
clinicaltrials@akesobio.com
+86(0760)89873999
Time Frame
Start Date: 2025-01-17
Estimated Completion Date: 2028-02
Participants
Target number of participants: 280
Treatments
Experimental: AK129
Phase Ia: Subjects will receive AK129: different doses on every 2 weeks.
Experimental: AK129+AK117
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.
Related Therapeutic Areas
Sponsors
Leads: Akeso

This content was sourced from clinicaltrials.gov