IBI322 Monotherapy or Combination Therapy in Subjects With Advanced Malignant Tumors.

A Phase 1a/1b Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 Monotherapy or Combination Therapy in Subjects With Advanced Malignant Tumors.

The Phase Ia study was designed to evaluate the tolerability, safety, PK, PD, immunogenicity and primary resistance of single therapy tumor activity in subjects with advanced or metastatic solid tumors who have failed standard treatment. Phase Ib study was designed to evaluate the safety and initial efficacy of IBI322 in monotherapy or combination therapy in subjects with advanced or metastatic solid tumors. Investigators and sponsors determine the recommended dose of IBI322 for phase Ib based on PK, PD, safety and efficacy data obtained during phase Ia.

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: Biological: IBI322

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shandong Province Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Histologically/cytologically confirmed, locally advanced unresectable or metastatic tumors.
2. Per RECIST1, at least one evaluable or measurable lesion.
3. Male or female subject above 18 years old, no more than 75 years old.
4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or 1.
5. Must have adequate organ function

Exclusion Criteria:

1. Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.
2. Direct coombs test was positive or have history of hemolytic anemia.
3. Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies.
4. 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.)
5. Subjects who have a history of blood transfusion within 2 weeks prior to the study.

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; Singal arm	Drug: Biological: IBI322; Recombinant anti-human CD47/PD-L1 bispecific antibody injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of DLT	21 Days
Number of treatment related AEs	up to 90 days post last dose
Number of patients with response	Last patient enrolled+24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Biomarker evaluation	from first dose until the date of first documented progression or date of death from any cause,whichever came first, assessed up to 24 months.
positive rate of ADA&NAB	from first dose until the date of first documented progression or date of death from any cause,whichever came first, assessed up to 24 months.
Area under the plsma concentration versus time curve(AUC)	Up to 90 days post last dose
Peak Plasma concentration(Cmax)	Up to 90 days post last dose
Clearance rate(CL)	Up to 90 days post last dose
the distribution volumn (Vd)	Up to 90 days post last dose
half-life period(t1/2)	Up to 90 days post last dose
Percentage of receptor occupancy	Up to 90 days post last dose
Hemoglobin level	Up to 90 days post last dose
Reticulocyte count (RET)	Up to 90 days post last dose
platelet count (PLT)	Up to 90 days post last dose

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
• Investigators: Principal Investigator: Jinming Yu, M.D., No.440, Jiyan Road, Jinang City, Shandong Province, China

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2021
• Primary Completion (Actual): December 3, 2022
• Study Completion (Actual): August 25, 2023

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 3, 2021

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 4, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CIBI322A105

Drug and device information, study documents

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