Clinical trial NCT04338659: A Phase 1a Study Evaluating the Safety, Tolerability, and Efficacy of IBI322 in Subjects With Advanced Cancers
Official title: A Phase 1a Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Advanced Malignant Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Malignant Tumors Lymphomas
Keywords: Cancer, advanced malignancy, metastatic, solid tumor, lymphoma
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-04-08
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 Criteria:

1. 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.
2. At least one evaluable lesion in Part A or at least one measurable lesion in Part B.
3. Male or female subject \> 18 years old.
4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
5. Must have adequate organ function including the following.
6. Subjects with life expectancy ≥ 12 weeks.
7. 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.
8. Willing to sign informed consent form and be able to comply with the study's rules and visits/related procedures.

Exclusion Criteria:

1. Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.
2. Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies.
3. Subjects who are on anticoagulants and/or require concomitant aspirin or other nonsteroids anti-inflammatory medications.
4. 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.
5. 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.
6. 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.
7. 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
8. Subjects who received whole pelvic radiotherapy prior to the enrollment.
9. Subjects with known cerebrospinal metastases and other known central nervous system metastases.
10. 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).
11. Known history of primary immunodeficiency.
12. Known history of active pulmonary tuberculosis.
13. Known history of allogenic organ transplantation and hematopoietic stem cell transplantation.
14. Known history of hypersensitivity to any components of the IBI322 injection.

Primary outcomes:
measure: Dose Limiting Toxicity (DLT)
timeFrame: .Day 1 - Day 21
measure: Treatment-related Adverse Events (TRAEs)
timeFrame: Day 1 - 90 days after last administration
Secondary outcomes:
measure: PK parameters
timeFrame: Up to 90 days post last dose
measure: PK parameters
timeFrame: Up to 90 days post last dose
measure: PK parameters
timeFrame: Up to 90 days post last dose
measure: PK parameters
timeFrame: Up to 90 days post last dose
measure: Positive rate of ADA and Nab
timeFrame: Up to 90 days post last dose
measure: Positive rate of Circulating Immune Complex
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: The Angeles Clinic And Research Institute
state: California
city: Westwood
country: United States
facility: The University of Kansas Cancer Center
state: Kansas
city: Jackson
country: United States
facility: University Of Mississippi Medical Center
state: Mississippi
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center - Investigational Cancer Therapies
state: Texas
Study officials:
References: