A Study of PD-1/CTLA-4 Bispecific AK104 in Relapsed or Re... | NCT04444141

Studies
A Study of PD-1/CTLA-4 Bispecific AK104 in Relapsed or Refractory Peripheral T-cell Lymphoma

NCT04444141

Sponsor

Akeso

Status

Terminated

Last Update Posted

Oct 19, 2022Actual

Enrollment

6Actual

Phase

Phase 1Phase 2

Conditions

Peripheral T-cell Lymphoma

Interventions

AK104

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to difficuty of erollment and consideration of clinical guideline,The sponsor decided to stop study.

Expanded Access Info

Start Date

May 15, 2020Actual

Primary Completion Date

Sep 30, 2022Actual

Completion Date

Sep 30, 2022Actual

First Submitted Date

Jun 21, 2020

First Submission Date that Met QC Criteria

Jun 21, 2020

First Posted Date

Jun 23, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2022

Last Update Posted Date

Oct 19, 2022Actual

Name	Class
Akeso Pharmaceuticals, Inc.	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of AK104，an anti- PD-1 and CTLA-4 bispecific antibody, in subjects with relapsed or refractory peripheral T cell lymphoma. The subject will receive AK104 450mg Q2W until unacceptable toxicity, confirmed disease progression, withdrawal of consent, or for a maximum of 24 months.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Label	Type	Description	Intervention Names
AK104	Experimental	AK104 450mg IV every 2 weeks (Q2W)	Biological: AK104

Name	Type	Description	Arm Group Labels	Other Names
AK104	Biological	The subjects will receive AK104 till disease progression or for a maximum of 24 months.	AK104

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective response rate (ORR)	Objective response is defined as the proportion of subjects with confirmed CR or PR according to the Lugano 2014 classification for lymphoma, assessed by the investigator.	Up to 2 years

Secondary Outcomes

Measure	Description	Time Frame
Progression-free survival (PFS)	Progression-free survival is defined as the time from the start of treatment with AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first.	Up to 2 years
Disease control rate (DCR)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with histologically or cytologically confirmed advanced Peripheral T-cell lymphoma.
Relapsed or refractory disease after at least 1 prior systemic treatment for the primary malignancy and not a candidate for other curative treatments.
Eastern Cooperative Oncology Group (ECOG) physical fitness score is 0 or 1.
Adequate organ functions
Effective methods of contraception.
Ability to provide written informed consent and to be compliant with the schedule of protocol assessments.

Exclusion Criteria:

Patients diagnosed as adult T cell lymphoma / leukemia (ATLL).
Any prior exposure to PD-1/PD-L1、CTLA-4 targeting agents.
Previous allogeneic stem cell transplant within 3 months prior to enrolment, active graft vs host disease (GVHD), or requiring transplant-related immunosuppression.
Serious systemic infections or local infections during the 2 months before screening.
History of cancer in 5 years before screening., including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved).
Have a known allergy or hypersensitivity to any biologic therapy at screening that would pose an unacceptable risk to the subject if participating in this study.
Has enrolled in any other trials during 3 months prior to screening or concurrently enrolled in any other trials.
Received allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
Subjects who received immunomodulatory drugs in 4 weeks before screening, including thymosin, interferon and interleukin, et al.
Patients who received radiotherapy, chemotherapy, targeted therapy (except TKI), immunotherapy within 4 weeks before screening, and patients who received TKI drugs within 2 weeks before screening.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Yuqin Song, MD	Peking University Cancer Hospital & Institute	Principal Investigator
Jun Zhu, MD	Peking University Cancer Hospital & Institute	Principal Investigator

ID	Term
D016399	Lymphoma, T-Cell
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type