Clinical trial NCT06642792: A Study of AK129 With or Without AK117 in PD(L)1-refractory Classic Hodgkin Lymphoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Classic Hodgkin Lymphoma
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Phase I: Number of participants with dose limiting toxicity (DLT)
timeFrame: Within the first 28 days following the first dose of study treatment.
measure: Phase I/II: Incidence and severity of adverse events (AEs)
timeFrame: Up to approximately 2 years.
measure: Phase I/II: Objective response rate (ORR)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Disease control rate (DCR)
timeFrame: Up to approximately 2 years
measure: Time to response (TTR)
timeFrame: Up to approximately 2 years
measure: Duration of response (DoR)
timeFrame: Up to approximately 2 years
measure: Progression-free survival (PFS)
timeFrame: Up to approximately 2 years
measure: Overall survival (OS)
timeFrame: Up to approximately 2 years
measure: Maximum concentration (Cmax)
timeFrame: Up to approximately 2 years
measure: Time to maximum concentration (Tmax)
timeFrame: Up to approximately 2 years
measure: Area under the curve (AUC)
timeFrame: Up to approximately 2 years
measure: Half-life (T1/2)
timeFrame: Up to approximately 2 years
measure: Anti-drug antibody (ADA)
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
Study officials:
affiliation: Akeso
name: Wenting Li, MD
role: STUDY_DIRECTOR
References: