A study to assess safety, tolerability, and anticancer activity of ISB 1442
- Conditions
- Health Condition 1: C900- Multiple myeloma
- Registration Number
- CTRI/2024/04/065308
- Lead Sponsor
- Ichnos Sciences SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
• Serum free light chain (sFLC) assay: involved free light chain (FLC) level = 10 mg/dL provided sFLC ratio is abnormal.
Cohort B: R/R MM Post-T-Cell Directed Therapy
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 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
• sFLC assay: involved FLC level = 10 mg/dL provided sFLC ratio is abnormal
5. Have a body weight = 40.0 kg at screening.
6. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
7. Have life expectancy of at least 3 months (from date of informed consent signing).
8. Have adequate organ function, including:
a. Estimated creatinine clearance =45 mL/min as calculated using the Cockcroft-Gault formula or 24-hour urine analysis.
b. Aspartate aminotransferase (AST, GOT) and alanine aminotransferase (ALT, GPT) =3.0 × ULN; bilirubin =1.5 × ULN. Patients with Gilberts syndrome may have a bilirubin level greater than 1.5 times ULN, per discussion between the Investigator and medical monitor.
9. Left ventricular ejection fraction (LVEF) =45% as assessed by echocardiogram (ECHO) or multiple gated acquisition (MUGA) scan.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Phase 1: Frequency and Severity of Treatment-Emergent Adverse Events (TEAEs) <br/ ><br>2. Phase 1: For MTD: Number of Dose-Limiting Toxicities (DLTS) During the First 28 Days After the First Administration of ISB 1442 (Cycle 1) in each cohort <br/ ><br>3. Phase 2a: Overall Response Rate (ORR) Based on investigators assessment according to International Myeloma Working Group (IMWG)Timepoint: 1. Up to 18 months <br/ ><br>2. Up to 28 days <br/ ><br>3. 18 months
- Secondary Outcome Measures
Name Time Method