Status:
COMPLETED
A Phase 1a Study Evaluating the Safety, Tolerability, and Efficacy of IBI322 in Subjects With Advanced Cancers
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Advanced Malignant Tumors Lymphomas
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in cancer subjects who failed standard treatment.
Detailed Description
A Phase 1a study evaluating the safety, tolerability and preliminary efficacy of IBI322 in subjects with advanced malignant tumors
Eligibility Criteria
Inclusion
- Subjects with histologically/cytologically confirmed unresectable or metastatic solid tumors or relapsed/recurrent lymphomas for which there are no available therapies known to confer clinical benefit.
- At least one evaluable lesion in Part A or at least one measurable lesion in Part B.
- Male or female subject \> 18 years old.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Must have adequate organ function including the following.
- Subjects with life expectancy ≥ 12 weeks.
- Female subjects of childbearing age or male subjects whose partners are women at childbearing age, need to use 2 highly effective contraceptive measures, including one barrier method, throughout the treatment period and 6 months after the treatment period.
- Willing to sign informed consent form and be able to comply with the study's rules and visits/related procedures.
Exclusion
- Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.
- Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies.
- Subjects who are on anticoagulants and/or require concomitant aspirin or other nonsteroids anti-inflammatory medications.
- Subjects who have a history of blood transfusion within 2 weeks prior to screening, or the use of erythropoietin (EPO), granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage-colony stimulating factor (GM-CSF), thrombopoietin (TPO) or IL-11 therapy.
- Subjects who received the last dose of antineoplastic therapy (chemotherapy, endocrine therapy, targeted therapy, immunotherapy or tumor embolization) within 4 weeks prior to the first dose of study drug. Subjects who received the last dose of radiotherapy within 3 weeks prior to the first dose of study drug.
- Subjects that received immunosuppressive drugs within 7 days prior to the first dose of study drug, excluding topical, intra-nasal, or inhaled glucocorticoids or systemic glucocorticoids (i.e. equivalent to no more than 10 mg prednisone/day) or other glucocorticoids of equivalent dosage through nasal spray, inhalation or other routes.
- Any ongoing AEs Grade 2 or higher as per NCI CTCAE v5.0 directly attributed to prior anti-tumor treatment with the exception of residual hair loss and fatigue
- Subjects who received whole pelvic radiotherapy prior to the enrollment.
- Subjects with known cerebrospinal metastases and other known central nervous system metastases.
- Subjects with active or suspected autoimmune diseases or with a history of documented autoimmune disease over the past 2 years (subjects can be included in the study: vitiligo, psoriasis, alopecia or Grave's disease subjects who do not require systemic treatment within 2 years; hypothyroidism subjects who require only thyroid hormone replacement therapy, and type I diabetes subjects who require only insulin replacement therapy).
- Known history of primary immunodeficiency.
- Known history of active pulmonary tuberculosis.
- Known history of allogenic organ transplantation and hematopoietic stem cell transplantation.
- Known history of hypersensitivity to any components of the IBI322 injection.
Key Trial Info
Start Date :
January 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2023
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04338659
Start Date
January 14 2021
End Date
February 28 2023
Last Update
October 10 2023
Active Locations (4)
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1
The Angeles Clinic And Research Institute
Los Angeles, California, United States, 90025
2
The University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
3
University Of Mississippi Medical Center
Jackson, Mississippi, United States, 39313
4
The University of Texas MD Anderson Cancer Center - Investigational Cancer Therapies
Houston, Texas, United States, 77030