A Study of CS1001 in Subjects With Relapsed or Refractory... | NCT03505996

Studies
A Study of CS1001 in Subjects With Relapsed or Refractory Classical Hodgkin Lymphoma

NCT03505996

Sponsor

CStone Pharmaceuticals

Status

Completed

Last Update Posted

Oct 31, 2022Actual

Enrollment

82Actual

Phase

Phase 2

Conditions

Hodgkin Lymphoma

Interventions

CS1001

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

ID	Type	Description	Link
CTR20180423	Registry Identifier	www.chinadrugtrials.org.cn

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 22, 2018Actual

Primary Completion Date

Feb 19, 2020Actual

Completion Date

Nov 1, 2021Actual

First Submitted Date

Apr 15, 2018

First Submission Date that Met QC Criteria

Apr 15, 2018

First Posted Date

Apr 23, 2018Actual

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 27, 2022

Last Update Posted Date

Oct 31, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

This is a multicenter, single-arm phase II study to evaluate the efficacy and safety of CS1001 monotherapy for relapsed/refractory classical Hodgkin Lymphoma (rr-cHL)

Detailed Description

Eligible subjects with rr-cHL who failed at least two prior lines of therapies are planned to receive CS1001 1200 mg intravenous infusion every three weeks until progression of disease, intolerable toxicity, consent withdrawn or death.The primary endpoint of this trial is objective response rate (ORR), as assessed by independent radiological review committee (IRRC) based on Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Label	Type	Description	Intervention Names
CS1001	Experimental	Participants will receive CS1001 1200 mg by intravenous infusion every three weeks	Biological: CS1001

Name	Type	Description	Arm Group Labels	Other Names
CS1001	Biological	Monoclonal antibody	CS1001

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective response rate (ORR)	The percentage of subjects whose best overall response is either complete response or partial response evaluated by IRRC according to Criteria for Response Assessment of Lymphoma: Lugano 2014 Classification	From first patient first visit to 6 month after last patient first visit

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with histologically confirmed cHL at study site.
Relapsed or refractory cHL that failed at least two lines of systemic therapy.
ECOG PS of 0-2.
Subjects with at least one measurable lesion at baseline.
Subjects treated by prior anti-cancer therapy whose toxicity resolved to baseline or =< Grade 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Subjects who agree to use highly effective contraception.

Exclusion Criteria:

Nodular lymphocyte predominant Hodgkin lymphoma or grey zone lymphoma.
Primary site in central nervous system (CNS) or CNS involvement.
Subjects currently participating in other clinical studies or use of any investigational drug within 4 weeks prior to the first dose of CS1001.
Subjects who had systemic corticosteroid or any other immunosuppressive therapy within 14 days prior to the first dose of CS1001.
Subject who had chemotherapy, immune therapy or biological therapy as systemic anti-cancer treatment within 28 days prior to the first dose of CS1001.
Receipt of traditional medicinal herbal preparations within 7 days prior to the first dose of CS1001.
Known history of human immunodefiency virus (HIV) infection and/or acquired immune deficiency syndrome.
Subjects with active Hepatitis B or C infection.
Subjects with active tuberculosis infection.
Subjects who received prior therapy with anti-PD-1, anti-PD-L1 or anti CTLA-4 monoclonal antibody.
Female subjects who are pregnant or breast-feeding.

For more information regarding trial participation, please contact at cstonera@cstonepharma.com

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

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders