CTRI/2024/04/065308
Recruiting
Phase 1
A Phase 1/2, First-in-Human, Multicentre, Open-Label, Dose Escalation and Dose-Expansion Study of Single-Agent ISB 1442 in Patients with Relapsed/Refractory Multiple Myeloma - NI
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Ichnos Sciences SA
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female patients aged 18 years or older.
- •2\. Be willing and able to provide written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act of 1996 \[HIPAA]) prior to any protocol related procedures, including screening evaluations
- •3\. Phase 1: Patients with pathologically confirmed multiple myeloma (MM) who have progressed on or after standard therapy (relapsed/refractory \[R/R] patients):
- •a) Must have received PIs, IMiDs, and anti\-CD38 therapies either in combination or as a single agent; and must not be candidates for regimens known to provide clinical benefits.
- •b) Must have measurable M\-protein (serum and/or 24\-hour urine, or serum free light chains).
- •4\. Phase 2a: Patients with pathologically confirmed MM who have progressed on or after standard therapy (R/R patients):
- •Cohort A: R/R MM
- •a) Must have measurable disease defined by at least 1 of the following abnormalities (as per IMWG criteria):
- •Serum M\-protein \= 0\.5 g/dL (IgA \= 0\.5 g/dL), or
- •Urine light\-chain (M\-protein) of \= 200 mg/24 hours, or
Exclusion Criteria
- •1\. Patients with relapsed disease where relapse is characterized only by minimal residual disease parameters (i.e., minimal residual disease positive).
- •2\. Participants with MM with disease where the only measurable parameter is plasmacytoma. Note: Prophylactic localized (spot) radiation for areas of pain is allowed
- •3\. Received treatment with anti\-CD38 antibodies or CD47 targeted therapies within 28 days of C1D1; systemic anticancer treatments within 14 days of (C1D1\) or any investigational products within 5 half\-lives of C1D1\. Note: Treatment with a single course of glucocorticoids is allowed (maximum dose of corticosteroids should not exceed the equivalent of 160 mg \[for example, 40 mg/day for 4 days] of dexamethasone). Hormonal therapy for prostate cancer or breast cancer (as adjuvant treatment), and treatment with bisphosphonates and receptor activator of nuclear factor kappa\-? ligand inhibitors are allowed.
- •4\. Received autologous stem cell transplantation within 12 weeks of C1D1\.
- •5\. Current participation in another interventional study, including other clinical trials with investigational agents (including investigational vaccines or investigational medical device for disease under study) within 4 weeks of C1D1 and throughout the duration of this trial.
- •6\. Active malignant central nervous system involvement
- •7\. Known to be refractory to platelet or RBC transfusions
- •8\. Known severe allergic or anaphylactic reactions to human recombinant proteins or excipients used in the ISB 1442 formulation.
- •9\. Prior radiation therapy within 14 days of C1D1 or prior irradiation to greater than 25% of the bone marrow. Note: Prophylactic localized (spot) radiation for areas of pain is allowed.
- •10\. QTc interval greater than 480 msec at screening using Fredericias QT correction formula.
Investigators
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