A Single-arm, Multicenter, Open-label, Phase I/II Study of AK105 as Monotherapy in Relapsed or Refractory Classic Hodgkin Lymphoma

Akeso1 site in 1 country94 target enrollmentAugust 13, 2018

ConditionsHodgkin's Lymphoma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Hodgkin's Lymphoma
Sponsor: Akeso
Enrollment: 94
Locations: 1
Primary Endpoint: Objective response rate (ORR) assessed by Independent Radiology Review Committee (IRRC) per the Lugano 2014 Classification
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 13, 2018

End Date

December 31, 2021

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Akeso

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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 AK
•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 AK
•Receipt of the last dose of nitrocarbamide or mitomycin C within 6 weeks prior to the first dose of AK
•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).

Outcomes

Primary Outcomes

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

Time Frame: Up to 2 years

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.

Number of subjects with adverse events (AEs)

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

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.

Secondary Outcomes

Duration of Response (DoR)(Up to 2 years)
Disease control rate (DCR)(Up to 2 years)
Number of subjects who develop detectable anti-drug antibodies (ADAs)(From first dose of AK105 through to 90 days after last dose of AK105)
Progression-free Survival (PFS)(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)
ORR assessed by Investigator(Up to 2 years)