Study of ISB 1342, a CD38/CD3 Bispecific Antibody, in Subjects With Previously Treated Multiple Myeloma
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ClinicalTrials.gov Identifier: NCT03309111 |
Recruitment Status : Unknown
Verified May 2022 by Ichnos Sciences SA.
Recruitment status was: Recruiting
First Posted : October 13, 2017
Last Update Posted : May 16, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Relapsed/Refractory Multiple Myeloma | Biological: ISB 1342 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 245 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1, First-in-Human, Multicenter, Open-Label, Two-Part Dose-Escalation and Cohort Expansion Study of Single-Agent ISB 1342 in Subjects With Previously Treated Multiple Myeloma |
Actual Study Start Date : | October 25, 2017 |
Estimated Primary Completion Date : | March 2024 |
Estimated Study Completion Date : | May 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: ISB 1342
Part 1: Cohorts of multiple ISB 1342 dose levels; Part 2: One dose regimen until disease progression or other discontinuation criterion is met
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Biological: ISB 1342
ISB-1342 is CD38 x CD3 BEAT® 1.0 bispecific antibody. ISB 1342 is administered by intravenous (IV) infusion or subcutaneous injection (SC) |
- Maximal tolerated dose (MTD) and/or recommended part 2 dose (RP2D) of ISB 1342 (Part 1) [ Time Frame: 28 days ]
- Proportion of subjects with an investigator-assessed objective response (at least a partial response or better), complete response, disease control (stable disease or better) to ISB 1342, per International Myeloma Working Group (IMWG) criteria (Part 2) [ Time Frame: 28 days ]
- Number of subjects with adverse events based on frequency and severity as assessed by common terminology criteria for adverse events (CTCAE) v5.0 (Part 1 and Part 2) [ Time Frame: up to 30 days post last dose ]
- Maximum serum concentration (Cmax) of ISB 1342 (Part 1 and Part 2) [ Time Frame: 28 days ]
- Time to reach maximum observed plasma concentration (Tmax) of ISB 1342 (Part 1 and Part 2) [ Time Frame: 28 days ]
- Area under the serum concentration time curve from zero to time t (AUC0-t) of ISB 1342 (Part 1 and Part 2) [ Time Frame: 28 days ]
- Area under the curve from time zero to end of dosing interval (AUC0-tau) of ISB 1342 (Part 1 and Part 2) [ Time Frame: 28 days ]
- Immunogenicity of ISB 1342 by anti-drug antibody (ADA) formation (Part 1 and Part 2) [ Time Frame: 28 days ]
- Percent incidence of neutralizing antibody formation from positive anti-drug antibody (ADA) samples assessed from baseline until end of treatment (EOT) (Part 1 and Part 2) [ Time Frame: 28 days ]
- Efficacy of ISB 1342 (duration of response [DOR]) (Part 1 and Part 2) [ Time Frame: 28 days ]
- Efficacy of ISB 1342 (disease control rate [DCR]) (Part 1 and Part 2) [ Time Frame: 28 days ]
- Efficacy of ISB 1342 (duration of disease control) (Part 1 and Part 2) [ Time Frame: 28 days ]
- Efficacy of ISB 1342 (time to minimal residual disease [MRD] negative status) (Part 1 and Part 2) [ Time Frame: 28 days ]
- Efficacy of ISB 1342 (progression free survival [PFS]) (Part 2) [ Time Frame: 28 days ]
- Efficacy of ISB 1342 (time to treatment failure [TTF]) (Part 2) [ Time Frame: 28 days ]
- Efficacy of ISB 1342 (time to disease progression [TTP]) (Part 2) [ Time Frame: 28 days ]
- Efficacy of ISB 1342 (overall survival [OS]) (Part 2) [ Time Frame: Time from first dose until death from any cause or end of study collection, whichever is later, assessed up to 60 months. ]
- Proportion of subjects with investigator-assessed objective response (at least a partial response or better), complete response, disease control (stable disease or better) to ISB 1342, per International Myeloma Working Group (IMWG) criteria (Part 1) [ Time Frame: 28 days ]
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Documented diagnosis of multiple myeloma with measurable disease (serum, urine, or free light chain) per International Myeloma Working Group (IMWG) criteria, including non-secretory or oligo-secretory multiple myeloma which has relapsed after or is refractory to prior therapies, including proteasome inhibitors (PIs), immunomodulators (IMiDs) and anti-CD38 targeted therapies (daratumumab, isatuximab).
- Eastern Cooperative Oncology Group (ECOG) performance-status score of 2 or less and 1 or less (for France).
- Adequate hematologic, renal, and hepatic functions
- Seronegative for hepatitis B antigen; positive hepatitis B tests can be further evaluated by confirmatory tests, and if viral load is negative, the subject can be enrolled.
- Seronegative for hepatitis C antibody; if positive, then further test for the presence of antigen by hepatitis C virus polymerase chain reaction (HCV PCR). If HCV antigen tests are negative, then the subject can be enrolled.
- Oxygen saturation level ≥92% on room air.
- Left ventricular ejection fraction (LVEF) ≥50% and no pericardial or pleural effusion at Screening
Exclusion Criteria:
- Active central nervous system involvement
- Exposure to daratumumab or isatuximab within 2 months prior to the start of study treatment
- Active plasma cell leukemia
- Active infectious disease
- Clinically significant cardiovascular and respiratory conditions
- History of HIV infection
- Subjects requiring prohibited concomitant medications
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309111
Contact: Ichnos Sciences Clinical Trials Administrator | (315) 583-1249 | clinicaltrials@ichnossciences.com |
Responsible Party: | Ichnos Sciences SA |
ClinicalTrials.gov Identifier: | NCT03309111 |
Other Study ID Numbers: |
ISB 1342-101 2016-005253-20 ( EudraCT Number ) |
First Posted: | October 13, 2017 Key Record Dates |
Last Update Posted: | May 16, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |