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NCT Number: NCT06642792

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beijing Cancer Hospital

Beijing, China

Location status: Recruiting

Location contact

Yuqin Song

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AK129

Drug

Subjects receive AK129 intravenously.

AK117

Drug

Subjects receive AK117 intravenously.

Primary outcomes

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

    Time frame: Within the first 28 days following the first dose of study treatment.

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

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

    Time frame: Up to approximately 2 years.

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

  3. Phase I/II: Objective response rate (ORR)

    Time frame: Up to approximately 2 years

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

Secondary outcomes

  1. Disease control rate (DCR)

    Time frame: Up to approximately 2 years

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

  2. Time to response (TTR)

    Time frame: Up to approximately 2 years

    The time from cycle 1 day 1(C1D1) to the first recorded response assessed by investigator per Lugano 2014 criteria.

  3. Duration of response (DoR)

    Time frame: Up to approximately 2 years

    The time from the first recorded response until disease progression assessed by investigator or death due to any cause, whichever occurs first.

  4. Progression-free survival (PFS)

    Time frame: Up to approximately 2 years

    The time from C1D1 until disease progression assessed by investigator or death due to any cause, whichever occurs first.

  5. Overall survival (OS)

    Time frame: Up to approximately 2 years

    The time from C1D1 until death due to any cause.

  6. Maximum concentration (Cmax)

    Time frame: Up to approximately 2 years

    The maximum concentration of the drug observed in the blood plasma after administration.

  7. Time to maximum concentration (Tmax)

    Time frame: Up to approximately 2 years

    The time taken to reach the maximum concentration (Cmax) of the drug in the blood plasma.

  8. Area under the curve (AUC)

    Time frame: Up to approximately 2 years

    The area under the plasma concentration versus time curve, which represents the total drug exposure over time.

  9. Half-life (T1/2)

    Time frame: Up to approximately 2 years

    The time required for the plasma concentration of the drug to decrease by half.

  10. Anti-drug antibody (ADA)

    Time frame: Up to approximately 2 years

    Number of subjects with detectable anti-drug antibodies.

Study contacts

Contact information is provided by the study sponsor or research team.

Wenting Li, MD

CONTACT

[email protected]

+86(0760)89873999

Sponsors and collaborators

Lead sponsor

Akeso

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Oct 15, 2024
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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