A Study of AK129 With or Without AK117 in PD(L)1-refractory Classic Hodgkin Lymphoma

NCT ID: NCT06642792

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-17
• Study Completion Date: 2028-02-29

Brief 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.

Conditions

Classic Hodgkin Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AK129

Phase Ia: Subjects will receive AK129: different doses on every 2 weeks.

Group Type: EXPERIMENTAL

AK129

Intervention Type: DRUG

Subjects receive AK129 intravenously.

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.

Group Type: EXPERIMENTAL

AK129

Intervention Type: DRUG

Subjects receive AK129 intravenously.

AK117

Intervention Type: DRUG

Subjects receive AK117 intravenously.

Interventions

AK129

Subjects receive AK129 intravenously.

Intervention Type: DRUG

AK117

Subjects receive AK117 intravenously.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Diagnosed with nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL) or gray zone lymphoma.
• Central nervous system (CNS) lymphoma involvement.
• Known history of human T-cell leukemia virus type 1 (HTLV-1) infection.
• Autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor T cell immunotherapy (CAR-T) within 90 days prior to the first dose of study treatment.
• Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation (allo-HSCT).
• Previous use of any agents targeting the CD47-SIRPα pathway, LAG-3 pathway, or similar targets.
• Has other malignancies within 3 years prior to the first dose or residual lesions from other malignancies diagnosed more than 3 years ago.
• Has an active autoimmune disease requiring systemic treatment within 2 years prior to the first dose.
• History of active or previously confirmed inflammatory bowel disease.
• History of interstitial lung disease requiring corticosteroid therapy, or current interstitial lung disease.
• Has known active Hepatitis B or Hepatitis C.
• Unresolved toxicity from previous anti-tumor treatment.
• Uncontrolled comorbidities.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akeso

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wenting Li, MD

Role: STUDY_DIRECTOR

Akeso

Locations

Beijing Cancer Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Wenting Li, MD

Role: CONTACT

clinicaltrials@akesobio.com

+86(0760)89873999

Facility Contacts

Yuqin Song

Role: primary

Other Identifiers

AK129-102

Identifier Type: -

Identifier Source: org_study_id