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

NCT04912466 | Completed Phase 1

• 1 other identifier: CIBI322A105
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• 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

Study Arms (1)

IBI322

EXPERIMENTAL

Singal arm

Drug: Biological: IBI322

Interventions

Biological: IBI322 DRUG

Recombinant anti-human CD47/PD-L1 bispecific antibody injection

IBI322

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically/cytologically confirmed, locally advanced unresectable or metastatic tumors.
• Per RECIST1, at least one evaluable or measurable 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

You may not qualify if:

• Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.
• Direct coombs test was positive or have history of hemolytic anemia.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Shandong Province Cancer Hospital

Jinan, Shandong, 250117, China

Location

Study Officials

• Jinming Yu, M.D.

  No.440, Jiyan Road, Jinang City, Shandong Province, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 3, 2021
• Study Start: July 21, 2021
• Primary Completion: December 3, 2022
• Study Completion: August 25, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-09

Locations

CN (1)