A Study Evaluating the Safety, Tolerability and Prelimina... | NCT05148442

Studies
A Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Myeloid Tumor

NCT05148442

Sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Status

Terminated

Last Update Posted

Sep 8, 2023Actual

Enrollment

1Actual

Phase

Phase 1

Conditions

Myeloid Tumor

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

Sep 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to the company's development strategy adjustment]

Expanded Access Info

Start Date

Dec 28, 2021Actual

Primary Completion Date

Jun 19, 2023Actual

Completion Date

Aug 29, 2023Actual

First Submitted Date

Nov 25, 2021

First Submission Date that Met QC Criteria

Nov 25, 2021

First Posted Date

Dec 8, 2021Actual

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

Sep 5, 2023

Last Update Posted Date

Sep 8, 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 Myeloid tumor patients.

Detailed Description

Phase 1a/1b study will be conducted to evaluate the tolerability, safety, PK, PD, immunogenicity and preliminary antitumor activity of IBI322 in patients with myeloid tumor. Phase 1a is the dose escalation part of the study and Phase 1b is the dose expansion part. Combination therapy with HMA(Azacitidine or Decitabine) will be evaluated.

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

1Actual

Label	Type	Description	Intervention Names
IBI322	Experimental		Drug: IBI322

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of treatment related AEs	safety and tolerability	Up to 90 days post last dose

Secondary Outcomes

Measure	Description	Time Frame
Number of patients with response	preliminary efficacy	Last patient enrolled+24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who met the diagnostic criteria of recurrent / refractory AML (WHO 2016)(primordial cells in bone marrow ≥ 5%) (excluding APL and bcr-abl positive AML ) and underwent treatment.
Patients who meet the diagnostic criteria of recurrent / refractory MDS (WHO 2016)and underwent treatment.
Patients with recurrent / refractory Essential thrombocythemia (WHO2016) after treatment (for Phase Ia)
Male or female subject above 18 years old
Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 ~ 2.
Must have adequate organ function

Exclusion Criteria:

Previous history with myeloproliferative Neoplasms(MPN) or MDS/MPN
Transformation or treatment related AML/MDS.
PV/MF/AML/MDS evolved from Essential thrombocythemia
Relapse after allogeneic hematopoietic stem cell transplantation, or autologous hematopoietic stem cell transplantation within 1 year
Central nervous system leukemia infiltration
Previous history of chronic hemolytic anemia or screening Coombe test positive
Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.
Previous exposure to chimeric antigen receptor T cell immunotherapy (CAR-T)
Patients who received immunotherapy, targeted therapy, biological therapy or any clinical research treatment within 14 days before receiving the first dose
Uncontrolled concurrent diseases
Subjects who are allergic to the ingredients of the study drug
Subjects who have used immunosuppressive drugs within 7 days before the first dose of study treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided