Actively Recruiting
A Phase I/II Study of AK129 (Bispecific Antibody Targeting LAG-3 and PD-1) Alone or With AK117 (Anti-CD47 Monoclonal Antibody) in Relapse or Refractory Classic Hodgkin Lymphoma After PD-1/L1 Inhibitor Treatment Failure
Led by Akeso · Updated on 2025-02-11
280
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of AK129, a bispecific antibody targeting LAG-3 and PD-1, alone or combined with AK117, an anti-CD47 monoclonal antibody, in patients with relapse or refractory classic Hodgkin lymphoma (cHL) who have not responded to prior PD-1/L1 inhibitor therapy. This phase I/II study focuses on patients whose disease has progressed despite previous treatment with PD-1/L1 inhibitors. The trial aims to find suitable doses and assess treatment impact in this specific group. The study includes multiple phases. In Phase Ia, participants receive varying doses of AK129 every two weeks. Phase Ib involves treatment with AK129 at different doses plus AK117 at 30 mg/kg every two weeks. Phase II continues with AK129 at the recommended Phase II dose from Phase Ib combined with AK117 at the same dose and schedule. Both drugs are given intravenously, and the dosing intervals are consistent across phases. Participants will be monitored for dose-limiting toxicities during the first 28 days after starting treatment and followed for up to two years to assess adverse events and treatment responses. Researchers will measure outcomes such as objective response rate, disease control rate, time to response, duration of response, progression-free survival, overall survival, and drug concentration levels. Safety evaluations and long-term monitoring will ensure comprehensive assessment of treatment effects over time.
CONDITIONS
Brief Title
A Study of AK129 With or Without AK117 in PD(L)1-refractory Classic Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival of at least 12 weeks
- Diagnosed with relapse or refractory classic Hodgkin lymphoma according to Lugano 2014 criteria
- Disease progression after treatment with PD-1 or PD-L1 inhibitor therapy
- Adequate organ function
- All participants of reproductive potential must agree to use effective contraception from screening until 120 days after last dose
You will not qualify if you...
- Diagnosis of nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma
- Central nervous system lymphoma involvement
- Known history of human T-cell leukemia virus type 1 (HTLV-1) infection
- Autologous stem cell transplantation or CAR-T therapy within 90 days before first dose
- History of allogeneic organ or hematopoietic stem cell transplantation
- Previous use of agents targeting CD47-SIRPα pathway, LAG-3 pathway, or similar targets
- Other malignancies within 3 years prior to first dose or residual lesions from earlier cancers
- Active autoimmune disease requiring systemic treatment within 2 years prior to first dose
- History of active or confirmed inflammatory bowel disease
- History or current interstitial lung disease requiring corticosteroid therapy
- Known active Hepatitis B or Hepatitis C infection
- Unresolved toxicity from previous anti-tumor treatments
- Uncontrolled comorbid conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 2 years
Participants receive AK129 alone or AK129 with AK117 intravenously every 2 weeks as part of the study treatment.
Biweekly visits for dosing and assessments
Duration - Up to approximately 2 years
Participants are monitored for safety and efficacy outcomes after treatment ends.
Scheduled visits for up to 2 years post-treatment
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
Research Team
W
Wenting Li, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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