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

NCT06642792 | Recruiting Phase 1

• 1 other identifier: AK129-102
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Phase I: Number of participants with dose limiting toxicity (DLT)

  Any untoward medical occurrence in a subject within the first 28 days following the first dose, considered related to the study treatment.

  Within the first 28 days following the first dose of study treatment.

• Phase I/II: Incidence and severity of adverse events (AEs)

  Any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

  Up to approximately 2 years.

• Phase I/II: Objective response rate (ORR)

  The proportion of subjects achieving complete response (CR) or partial response (PR) assessed by investigator per Lugano 2014 criteria.

  Up to approximately 2 years

Secondary Outcomes (10)

• Disease control rate (DCR)

  Up to approximately 2 years

• Time to response (TTR)

  Up to approximately 2 years

• Duration of response (DoR)

  Up to approximately 2 years

• Progression-free survival (PFS)

  Up to approximately 2 years

• Overall survival (OS)

  Up to approximately 2 years

Study Arms (2)

AK129

EXPERIMENTAL

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

Drug: AK129

AK129+AK117

EXPERIMENTAL

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.

Drug: AK129; Drug: AK117

Interventions

AK129 DRUG

Subjects receive AK129 intravenously.

AK129; AK129+AK117

AK117 DRUG

Subjects receive AK117 intravenously.

AK129+AK117

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

RECRUITING

Study Officials

• Wenting Li, MD

  Akeso

  STUDY DIRECTOR

Central Study Contacts

Wenting Li, MD

CONTACT

+86(0760)89873999; clinicaltrials@akesobio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 15, 2024
• Study Start: January 17, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)