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

Akeso

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Classic Hodgkin Lymphoma

Treatments: Drug: AK117; Drug: AK129

Study type: Interventional

Funder types: Industry

Identifiers

NCT06642792

AK129-102

Details and patient eligibility

About

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.

Enrollment: 280 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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280 participants in 2 patient groups

AK129

Experimental group

Description:

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

Treatment:

Drug: AK129

AK129+AK117

Experimental group

Description:

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.

Treatment:

Drug: AK129

Drug: AK117