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

A Phase Ia/Ib Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Myeloid Tumor

This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in Myeloid tumor patients.

Study Overview

• Status: Terminated
• Conditions: Myeloid Tumor
• Intervention / Treatment: Drug: IBI322

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • the First Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. Patients who meet the diagnostic criteria of recurrent / refractory MDS (WHO 2016)and underwent treatment.
3. Patients with recurrent / refractory Essential thrombocythemia (WHO2016) after treatment (for Phase Ia)
4. Male or female subject above 18 years old
5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 ~ 2.
6. Must have adequate organ function

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBI322	Drug: IBI322; Recombinant anti-human CD47/PD-L1 bispecific antibody

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2021
• Primary Completion (Actual): June 19, 2023
• Study Completion (Actual): August 29, 2023

Study Registration Dates

• First Submitted: November 25, 2021
• First Submitted That Met QC Criteria: November 25, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Decitabine; Azacitidine
• Other Study ID Numbers: CIBI322A106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No