Brief Summary
This study is a first-in-human, Phase 1, open-label study that will evaluate safety and anti-myeloma activity of ISB 2001 in participants with relapsed/refractory multiple myeloma (R/R MM).
Brief Title
Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)
Detailed Description
The study will enroll participants with R/R MM that have been treated with immunomodulatory drugs (IMiDs), proteasome inhibitors, and anti-CD38 therapies either in combination or as a single agent and are refractory to, or intolerant of, established therapies known to provide clinical benefit in MM.
The study will be conducted in two parts:
* Part 1: Dose escalation
* Part 2: Dose expansion
Dose escalation will continue until either the maximum tolerated dose (MTD) is defined, the maximum planned dose is reached, or a recommended phase 2 dose (RP2D) is selected. Dose expansion cohorts will be initiated to further confirm safety and optimal biologically active dose. Participants will receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment, or participant withdrawal from the study.
The study will be conducted in two parts:
* Part 1: Dose escalation
* Part 2: Dose expansion
Dose escalation will continue until either the maximum tolerated dose (MTD) is defined, the maximum planned dose is reached, or a recommended phase 2 dose (RP2D) is selected. Dose expansion cohorts will be initiated to further confirm safety and optimal biologically active dose. Participants will receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment, or participant withdrawal from the study.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
(315) 583-1249
Central Contact Email
clinicaltrials@ichnossciences.com
Completion Date
Completion Date Type
Estimated
Conditions
Relapsed/Refractory Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
1. Participants with pathologically confirmed MM with measurable M-protein: serum and/or 24 hour urine, serum-free light chains or measurable isolated plasmacytoma
2. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
3. Must have adequate hematologic, hepatic, renal, and cardiac functions
Exclusion Criteria:
1. Active malignant central nervous system involvement
2. Uncontrolled infection requiring systemic antibiotic therapy or other serious infection prior to C1D1
3. History of autoimmune disease requiring systemic immunosuppressive therapy
4. Any concurrent or uncontrolled medical, comorbid, psychiatric or social condition that would limit compliance with study procedures, interfere with the study results, substantially increase the risk of AEs, compromise ability to provide written informed consent or, in the opinion of the Investigator, constitute a hazard for participating in this study.
5. Female subjects who are lactating and breastfeeding or have a positive pregnancy test during the screening period or on Day 1 before first dose of ISB 2001.
1. Participants with pathologically confirmed MM with measurable M-protein: serum and/or 24 hour urine, serum-free light chains or measurable isolated plasmacytoma
2. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
3. Must have adequate hematologic, hepatic, renal, and cardiac functions
Exclusion Criteria:
1. Active malignant central nervous system involvement
2. Uncontrolled infection requiring systemic antibiotic therapy or other serious infection prior to C1D1
3. History of autoimmune disease requiring systemic immunosuppressive therapy
4. Any concurrent or uncontrolled medical, comorbid, psychiatric or social condition that would limit compliance with study procedures, interfere with the study results, substantially increase the risk of AEs, compromise ability to provide written informed consent or, in the opinion of the Investigator, constitute a hazard for participating in this study.
5. Female subjects who are lactating and breastfeeding or have a positive pregnancy test during the screening period or on Day 1 before first dose of ISB 2001.
Inclusion Criteria
Inclusion Criteria:
1. Participants with pathologically confirmed MM with measurable M-protein: serum and/or 24 hour urine, serum-free light chains or measurable isolated plasmacytoma
2. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
3. Must have adequate hematologic, hepatic, renal, and cardiac functions
1. Participants with pathologically confirmed MM with measurable M-protein: serum and/or 24 hour urine, serum-free light chains or measurable isolated plasmacytoma
2. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
3. Must have adequate hematologic, hepatic, renal, and cardiac functions
Gender
All
Gender Based
false
Keywords
ISB 2001
Relapsed/refractory multiple myeloma
Open-label
Dose escalation
Dose expansion
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05862012
Org Class
Industry
Org Full Name
Ichnos Sciences SA
Org Study Id
ISB 2001-101
Overall Status
Recruiting
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Phase 1, First-in-Human, Multicenter, Open-Label, Dose Escalation and Dose-Expansion Study of Single-Agent ISB 2001 in Subjects With Relapsed/Refractory Multiple Myeloma
Primary Outcomes
Outcome Measure
Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs)
Outcome Time Frame
Up to 18 months
Outcome Measure
Number of Dose-Limiting Toxicities (DLT) During the First 28 Days After the First Administration of ISB 2001 (Cycle 1) in Each Cohort (Part 1)
Outcome Time Frame
Up to 28 days
Secondary Outcomes
Outcome Time Frame
Up to 28 days
Outcome Measure
Maximum Concentration (Cmax) of ISB 2001 in Serum
Outcome Time Frame
Up to 28 days
Outcome Measure
Time to Reach Maximum Concentration (Tmax) of ISB 2001 in Serum
Outcome Time Frame
Up to 28 days
Outcome Measure
Area Under the Concentration Time Curve in Dosing Intervals (AUC0-tau) of ISB 2001 in Serum
Outcome Time Frame
Up to 28 days
Outcome Measure
Area Under the Concentration Time Curve From Zero to Time t (AUC0-t) of ISB 2001 in Serum
Outcome Time Frame
Baseline to 18 months
Outcome Measure
Percent Incidence of Anti-Drug Antibody (ADA), Neutralizing Antibody (nAb) and Titer of ADA From Baseline Until End-of-Treatment (EOT)
Outcome Time Frame
18 months
Outcome Measure
Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG)
Outcome Time Frame
18 months
Outcome Measure
Complete Response Rate (CRR) Based on International Myeloma Working Group (IMWG)
Outcome Time Frame
18 months
Outcome Measure
Duration of Response (DOR) Based on International Myeloma Working Group (IMWG)
Outcome Time Frame
18 months
Outcome Measure
Time to Progression (TTP)
Outcome Time Frame
18 months
Outcome Measure
Time to Next Treatment (TTNT)
Outcome Time Frame
18 months
Outcome Measure
Time to Response (TTR)
Outcome Time Frame
18 months
Outcome Measure
Progression Free Survival (PFS)
Outcome Time Frame
18 months
Outcome Measure
Overall Survival (OS)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
David Levitz
Investigator Email
dlevitz@montefiore.org
Investigator Sponsor Organization
External
Study Department
Oncology (Medical/Hematologic)
Study Division
Medical and Hematologic Oncology
Categories Mesh Debug
Blood & Bone Marrow Cancers --- MULTIPLE MYELOMA
Blood & Bone Marrow Cancers --- NEOPLASMS, PLASMA CELL
Blood & Bone Marrow Cancers --- NEOPLASMS BY HISTOLOGIC TYPE
Cancer --- NEOPLASMS
Endocrine System Cancers --- NEOPLASMS
Gastrointestinal (GI) Cancers --- NEOPLASMS
Gynecologic Cancers --- NEOPLASMS
Lung & Chest Cancers --- NEOPLASMS
Prostate Cancer --- NEOPLASMS
Blood & Bone Marrow Cancers --- HEMOSTATIC DISORDERS
Blood & Bone Marrow Cancers --- VASCULAR DISEASES
Heart/Cardiovascular --- VASCULAR DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- PARAPROTEINEMIAS
Blood & Bone Marrow Cancers --- BLOOD PROTEIN DISORDERS
Blood Disorders --- HEMATOLOGIC DISEASES
Blood & Bone Marrow Cancers --- HEMATOLOGIC DISEASES
Blood & Bone Marrow Cancers --- HEMORRHAGIC DISORDERS
Blood & Bone Marrow Cancers --- LYMPHOPROLIFERATIVE DISORDERS
Blood & Bone Marrow Cancers --- IMMUNOPROLIFERATIVE DISORDERS
Infectious Disease --- IMMUNE SYSTEM DISEASES
Lung --- IMMUNE SYSTEM DISEASES
MeSH Terms
MULTIPLE MYELOMA
NEOPLASMS, PLASMA CELL
NEOPLASMS BY HISTOLOGIC TYPE
NEOPLASMS
HEMOSTATIC DISORDERS
VASCULAR DISEASES
CARDIOVASCULAR DISEASES
PARAPROTEINEMIAS
BLOOD PROTEIN DISORDERS
HEMATOLOGIC DISEASES
HEMIC AND LYMPHATIC DISEASES
HEMORRHAGIC DISORDERS
LYMPHOPROLIFERATIVE DISORDERS
IMMUNOPROLIFERATIVE DISORDERS
IMMUNE SYSTEM DISEASES