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Completed

NCT Number: NCT04912466

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.

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Key information

Conditions

Advanced Solid Tumor

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shandong Province Cancer Hospital

Jinan, Shandong, 250117, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Biological: IBI322

Drug

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

Primary outcomes

  1. Number of DLT

    Time frame: 21 Days

  2. Number of treatment related AEs

    Time frame: up to 90 days post last dose

  3. Number of patients with response

    Time frame: Last patient enrolled+24 months

Secondary outcomes

  1. Biomarker evaluation

    Time frame: 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

    Time frame: 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)

    Time frame: Up to 90 days post last dose

  4. Peak Plasma concentration(Cmax)

    Time frame: Up to 90 days post last dose

  5. Clearance rate(CL)

    Time frame: Up to 90 days post last dose

  6. the distribution volumn (Vd)

    Time frame: Up to 90 days post last dose

  7. half-life period(t1/2)

    Time frame: Up to 90 days post last dose

  8. Percentage of receptor occupancy

    Time frame: Up to 90 days post last dose

  9. Hemoglobin level

    Time frame: Up to 90 days post last dose

  10. Reticulocyte count (RET)

    Time frame: Up to 90 days post last dose

  11. platelet count (PLT)

    Time frame: Up to 90 days post last dose

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jun 3, 2021
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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