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

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04912466
• Other study ID #: CIBI322A105
• Status: Completed
• Phase: Phase 1
• Start date: July 21, 2021
• Est. completion date: August 25, 2023

Study information

• Verified date: September 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: August 25, 2023
• Est. primary completion date: December 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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, SIRPa antibody, or CD47/SIRPa 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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• Biological: IBI322
Recombinant anti-human CD47/PD-L1 bispecific antibody injection

Locations

Country	Name	City	State
China	Shandong Province Cancer Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of DLT		21 Days
Primary	Number of treatment related AEs		up to 90 days post last dose
Primary	Number of patients with response		Last patient enrolled+24 months
Secondary	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.
Secondary	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.
Secondary	Area under the plsma concentration versus time curve(AUC)		Up to 90 days post last dose
Secondary	Peak Plasma concentration(Cmax)		Up to 90 days post last dose
Secondary	Clearance rate(CL)		Up to 90 days post last dose
Secondary	the distribution volumn (Vd)		Up to 90 days post last dose
Secondary	half-life period(t1/2)		Up to 90 days post last dose
Secondary	Percentage of receptor occupancy		Up to 90 days post last dose
Secondary	Hemoglobin level		Up to 90 days post last dose
Secondary	Reticulocyte count (RET)		Up to 90 days post last dose
Secondary	platelet count (PLT)		Up to 90 days post last dose