Safety and Efficacy of IBI322 in Chinese Subjects With Ad... | NCT04328831

Studies
Safety and Efficacy of IBI322 in Chinese Subjects With Advanced Malignant Tumors

NCT04328831

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Status

Completed

Last Update Posted

Oct 10, 2023Actual

Enrollment

94Actual

Phase

Phase 1

Conditions

Advanced Malignancies

Interventions

IBI322

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 2023

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

Jul 31, 2020Actual

Primary Completion Date

Aug 28, 2023Actual

Completion Date

Aug 28, 2023Actual

First Submitted Date

Mar 24, 2020

First Submission Date that Met QC Criteria

Mar 30, 2020

First Posted Date

Mar 31, 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 6, 2023

Last Update Posted Date

Oct 10, 2023Actual

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 phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in cancer subjects who failed standard treatment.

Detailed Description

Phase 1a/Ib study will be conducted to evaluate the tolerability, safety, PK, PD, immunogenicity and preliminary antitumor activity of IBI322 in China. Phase 1a is dose escalation and plans to enroll approximately 38-60 subjects with advanced malignant solid tumors who failed the standard treatment. Phase Ib is dose expansion, and plans to enroll approximately 180 subjects with advanced malignant tumors.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

94Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IBI322	Other	Single arm	Biological: IBI322

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IBI322	Biological	Recombinant anti-human CD47/PD-L1 bispecific antibody injection	IBI322

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of DLT		28 days
Number of treatment related AEs		90 days post last dose
Number of patients with response		Last patient enrolled+24 weeks

Secondary Outcomes

Measure	Description	Time Frame
PK parameters: The area under the curve (AUC)		Up to 90 days post last dose
PK parameters: Maximum concentration (Cmax)		Up to 90 days post last dose
PK parameters: Time at which maximum concentration (Tmax)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically/cytologically confirmed, locally advanced unresectable or metastatic tumors.
At least one evaluable lesion.
Male or female subject above 18 years old, no more than 75 years old.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or 1.
Must have adequate organ function

Exclusion Criteria:

Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.
Previous exposure to any anti-programmed death receptor 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) /anti-programmed death ligand 2 (PD-L2) antibodies
Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies.
Patients who are on anticoagulants and /or require concomitant aspirin or other nonsteroids anti-inflammatory medications. Patients with a history of a bleeding diathesis (von Willebrand disease, end stage liver disease, hemophilia, etc.)
Subjects who have a history of blood transfusion within 2 weeks prior to the study.

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