Study of ISB 1342, a CD38/CD3 Bispecific Antibody, in Subjects With Previously Treated Multiple Myeloma
Purpose
The purpose of this study is to determine the safety profile, maximum tolerable dose (MTD) and cohort expansion of single-agent ISB 1342 in subjects with multiple myeloma who have received prior therapies.
Condition
- Multiple Myeloma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Adults with progressive or relapsed multiple myeloma (by IMWG) refractory to proteasome inhibitors (PIs), immunomodulators (IMiDs) and daratumumab. - Measurable disease, defined as any quantifiable monoclonal protein value - ECOG performance-status score of 2 or less - Life expectancy of at least 3 months - Recovered from any previous surgery and no history of major surgery within the last 28 days prior to start of study drug
Exclusion Criteria
- Any condition that, in the opinion of the Investigator, would interfere with evaluation of the study drug or interpretation of subject safety or study results. - Active infectious disease considered by the Investigator to be incompatible with the protocol. - Evidence of clinically significant cardiovascular and respiratory conditions - Anti-myeloma treatment within 2 weeks - Use of any investigational drug within the past 4 weeks
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental ISB 1342 |
Open-label dose escalation of ISB 1342 |
|
Recruiting Locations
Ichnos Investigational Site 2
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Ichnos Investigational Site 10
Denver, Colorado 80218
Denver, Colorado 80218
Ichnos Investigational Site 1
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
Ichnos Investigational Site 6
New York, New York 10029
New York, New York 10029
Ichnos Investigational Site 4
New York, New York 10065
New York, New York 10065
Ichnos Investigational Site 9
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Ichnos Investigational Site 5
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Ichnos Investigational Site 7
Madison, Wisconsin 53792
Madison, Wisconsin 53792
More Details
- NCT ID
- NCT03309111
- Status
- Recruiting
- Sponsor
- Ichnos Sciences SA
Study Contact
Ichnos CT Disclosure Desk(201) 786-3216
clinicaltrialsdisclosuredesk@ichnossciences.com