A Study of Anti-PD-1 AK105 in Patients With Relapsed or Refractory Classic Hodgkin Lymphoma

NCT03722147 | Completed Phase 1 FDA Drug

• 1 other identifier: AK105-201
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open-label, multicenter, phase I/II study to evaluate efficacy and safety of AK105 in patients with relapsed or refractory classic Hodgkin lymphoma.

Conditions

Hodgkin's Lymphoma

Keywords

immunotherapy; immuno-oncology; Classic Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

• Objective response rate (ORR) assessed by Independent Radiology Review Committee (IRRC) per the Lugano 2014 Classification

  ORR defined as the proportion of subjects who achieves a best overall response of CR or PR, assessed by IRRC per the Lugano 2014 Classification.

  Up to 2 years

• Number of subjects with adverse events (AEs)

  An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.

  From the time of informed consent signed through 90 days after the last dose of AK105

Secondary Outcomes (6)

• ORR assessed by Investigator

  Up to 2 years

• Duration of Response (DoR)

  Up to 2 years

• Progression-free Survival (PFS)

  Up to 2 years

• Disease control rate (DCR)

  Up to 2 years

• Minimum observed concentration (Cmin) of AK105 at steady state

  From first dose of AK105 through 30 days after last dose of AK105

Study Arms (1)

AK105

EXPERIMENTAL

AK105 200 mg intravenously (IV) every-2-weeks (Q2W)

Biological: AK105

Interventions

AK105 BIOLOGICAL

AK105 200 mg intravenously (IV) every-2-weeks (Q2W)

AK105

Eligibility Criteria

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

You may qualify if:

• Written and signed informed consent
• Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
• Histologically confirmed classic Hodgkin's lymphoma (cHL) (based on tumor tissue obtained within 3 years prior to enrollment).
• Relapsed (disease progression during or after most recent therapy) or refractory (failure to achieve CR or PR after most recent therapy) cHL and meet any of the following criterions:
• Recurrence or disease progression after autologous hematopoietic stem cell transplantation.
• For subject without receiving , the subject has received at least 2 lines of prior systemic chemotherapy. Refractory subject is defined as subject who has not achieved PR after at least 2 cycles of treatment, or subject who has not achieved CR after at least 4 cycles of treatment. If the best response to treatment is PD or the reason for ending the treatment is PD, the subject is consider as refractory without requirement on the number of cycles of treatment that the subject has received. For relapsed subjects, disease progression occurred for the subject who has received at least 2 line of prior systemic chemotherapy.
• Subject must have at least one measurable lesion (\> 1.5 cm in the longest diameter, or \> 1 cm in the longest diameter with uptake on 18FDG-PET)according to the Lugano 2014 criteria.
• Adequate organ functions.
• Use effective methods of contraception.

You may not qualify if:

• Known nodular lymphoma predominant Hodgkin lymphoma or Grey zone lymphoma.
• Lymphoma involving the central nervous system.
• Participated in other clinical studies of experimental drugs or received research treatment or used experimental equipment within 4 weeks prior to the first dose of AK105.
• Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study.
• Receipt of the last radiotherapy or the last dose of anticancer therapy (chemotherapy, target therapy, immunotherapy or tumor embolism, etc.) with 4 weeks prior to the first dose of AK105. Receipt of the last dose of nitrocarbamide or mitomycin C within 6 weeks prior to the first dose of AK105.
• Prior exposure to any anti-PD-1, anti-PD-L1, anti-CTL4 antibody or any other antibody or drug targeting T-cell costimulation or checkpoint pathways such as ICOS, or agonists such as CD40, CD137, GITR, OX40 etc..
• Had other active malignancies within 5 years prior to enrollment. Locally curable cancer (manifested as cured) is excluded, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ.
• Active, known or suspected autoimmune diseases, or a history of the disease within the past 2 years, except the following: vitiligo, alopecia, Graves' disease, psoriasis or eczema that do not require systemic treatment within the last 2 years, hypothyroidism (caused by autoimmune thyroiditis) only requiring a stable dose of hormone replacement therapy, type I diabetes requiring only a stable dose of insulin replacement therapy, or diseases not expected to recur in the absence of external triggering factors.
• Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis or chronic diarrhea).
• Subjects with a condition requiring systemic treatment with either corticosteroid (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration.
• History of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
• History of primary immunodeficiency.
• History of active tuberculosis.
• History of allogeneic stem cell transplantation or organ transplantation.
• Autologous hematopoietic stem cell transplantation performed within 90 days prior to the first dose of AK105.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beiing, 100142, China

Location

Related Publications (1)

• Huang Z, Pang X, Zhong T, Qu T, Chen N, Ma S, He X, Xia D, Wang M, Xia M, Li B. Penpulimab, an Fc-Engineered IgG1 Anti-PD-1 Antibody, With Improved Efficacy and Low Incidence of Immune-Related Adverse Events. Front Immunol. 2022 Jun 27;13:924542. doi: 10.3389/fimmu.2022.924542. eCollection 2022.

  PMID: 35833116 DERIVED

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

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

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 26, 2018
• Study Start: August 13, 2018
• Primary Completion: January 10, 2020
• Study Completion: December 31, 2021
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)