Clinical trial NCT04912466: IBI322 Monotherapy or Combination Therapy in Subjects With Advanced Malignant Tumors.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2021-06-03
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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, SIRPα antibody, or CD47/SIRPα 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.

Primary outcomes:
measure: Number of DLT
timeFrame: 21 Days
measure: Number of treatment related AEs
timeFrame: up to 90 days post last dose
measure: Number of patients with response
timeFrame: Last patient enrolled+24 months
Secondary outcomes:
measure: Biomarker evaluation
timeFrame: 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.
measure: positive rate of ADA&NAB
timeFrame: 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.
measure: Area under the plsma concentration versus time curve(AUC)
timeFrame: Up to 90 days post last dose
measure: Peak Plasma concentration(Cmax)
timeFrame: Up to 90 days post last dose
measure: Clearance rate(CL)
timeFrame: Up to 90 days post last dose
measure: the distribution volumn (Vd)
timeFrame: Up to 90 days post last dose
measure: half-life period(t1/2)
timeFrame: Up to 90 days post last dose
measure: Percentage of receptor occupancy
timeFrame: Up to 90 days post last dose
measure: Hemoglobin level
timeFrame: Up to 90 days post last dose
measure: Reticulocyte count (RET)
timeFrame: Up to 90 days post last dose
measure: platelet count (PLT)
timeFrame: Up to 90 days post last dose
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Province Cancer Hospital
state: Shandong
Study officials:
affiliation: No.440, Jiyan Road, Jinang City, Shandong Province, China
name: Jinming Yu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: