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

Sponsor
Innovent Biologics (Suzhou) Co. Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04912466
Collaborator
(none)
36
1
1
24
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Biological: IBI322
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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.
Anticipated Study Start Date :
Jun 20, 2021
Anticipated Primary Completion Date :
Jun 20, 2022
Anticipated Study Completion Date :
Jun 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: IBI322

Singal arm

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

Outcome Measures

Primary Outcome Measures

  1. Number of DLT [21 Days]

  2. Number of treatment related AEs [up to 90 days post last dose]

  3. Number of patients with response [Last patient enrolled+24 months]

Secondary Outcome Measures

  1. 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.]

  2. 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.]

  3. Area under the plsma concentration versus time curve(AUC) [Up to 90 days post last dose]

  4. Peak Plasma concentration(Cmax) [Up to 90 days post last dose]

  5. Clearance rate(CL) [Up to 90 days post last dose]

  6. the distribution volumn (Vd) [Up to 90 days post last dose]

  7. half-life period(t1/2) [Up to 90 days post last dose]

  8. Percentage of receptor occupancy [Up to 90 days post last dose]

  9. Hemoglobin level [Up to 90 days post last dose]

  10. Reticulocyte count (RET) [Up to 90 days post last dose]

  11. platelet count (PLT) [Up to 90 days post last dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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, SIRPĪ± antibody, or CD47/SIRPĪ± 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shandong Province Cancer Hospital Jinan Shandong China 250117

Sponsors and Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

Investigators

  • Principal Investigator: Jinming Yu, M.D., No.440, Jiyan Road, Jinang City, Shandong Province, China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier:
NCT04912466
Other Study ID Numbers:
  • CIBI322A105
First Posted:
Jun 3, 2021
Last Update Posted:
Jun 3, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 3, 2021