ISB 1442 SC injection escalating doses for Neoplasms, Plasma Cell

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The Alfred Hospital-Melbourne, Melbourne, Australia
Neoplasms, Plasma Cell+2 More
ISB 1442 SC injection escalating doses - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is a first-in-human, Phase 1/2, open label study that will evaluate safety and efficacy of ISB 1442 in relapsed/refractory multiple myeloma (R/R MM).

Eligible Conditions

  • Neoplasms, Plasma Cell
  • Relapsed Or Refractory Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Neoplasms, Plasma Cell

Study Objectives

3 Primary · 14 Secondary · Reporting Duration: 18 months

18 Months
Phase 1 and Phase 2: Overall survival (OS)
Phase 1 and Phase 2: Progression free survival (PFS)
Phase 1 and Phase 2: Time to Next Treatment (TTNT)
Phase 1 and Phase 2: Time to Progression (TTP)
Phase 1 and Phase 2: Time to Response (TTR)
18 months
Phase 1 and Phase 2: Complete Response Rate (CRR) Based on International Myeloma Working Group (IMWG)
Phase 1 and Phase 2: Duration of Response (DOR) Based on International Myeloma Working Group (IMWG)
Phase 1: Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG)
Phase 2: Frequency and Severity of Treatment Emergent Adverse Events (TEAEs)
Phase 2: Multiple Myeloma: Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG)
Baseline to 18 months
Percent Incidence of Anti-Drug Antibody (ADA) and Neutralizing Antibody (nAb) From Baseline Until End-of-Treatment (EOT)
Up to 18 months
Phase 1: Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs)
Up to 28 days
Area Under the Concentration Time Curve From Zero to Time t (AUC0-t) of ISB 1442 in Serum
Area Under the Concentration Time Curve in Dosing Intervals (AUC0-tau) of ISB1442 in Serum
Maximum Concentration (Cmax) of ISB 1442 in Serum
Phase 1: Number of Dose-Limiting Toxicities (DLTS) During the First 28 Days After the First Administration of ISB 1442 (Cycle 1)
Time to Reach Maximum Concentration (Tmax) of ISB 1442 in Serum

Trial Safety

Safety Progress

1 of 3

Other trials for Neoplasms, Plasma Cell

Trial Design

3 Treatment Groups

Phase 2 (Dose Expansion): Cohort A: R/R Multiple Myeloma
1 of 3
Phase 2 (Dose Expansion): Cohort B: R/R MM Post-T-cell-Directed Therapy
1 of 3
Phase 1: Dose escalation
1 of 3
Experimental Treatment

121 Total Participants · 3 Treatment Groups

Primary Treatment: ISB 1442 SC injection escalating doses · No Placebo Group · Phase 1 & 2

Phase 2 (Dose Expansion): Cohort A: R/R Multiple Myeloma
Drug
Experimental Group · 1 Intervention: ISB 1442 SC injection at RP2D · Intervention Types: Drug
Phase 2 (Dose Expansion): Cohort B: R/R MM Post-T-cell-Directed Therapy
Drug
Experimental Group · 1 Intervention: ISB 1442 SC injection at RP2D · Intervention Types: Drug
Phase 1: Dose escalation
Drug
Experimental Group · 1 Intervention: ISB 1442 SC injection escalating doses · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 18 months
Closest Location: Mount Sinai · New York, NY
Photo of fl mount sinai medical center 1Photo of fl mount sinai medical center 2Photo of fl mount sinai medical center 3
2007First Recorded Clinical Trial
2 TrialsResearching Neoplasms, Plasma Cell
33 CompletedClinical Trials

Who is running the clinical trial?

Ichnos Sciences SALead Sponsor
5 Previous Clinical Trials
808 Total Patients Enrolled
1 Trials studying Neoplasms, Plasma Cell
245 Patients Enrolled for Neoplasms, Plasma Cell

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a male or female aged 18 years or older.
You are willing and able to provide written informed consent and any locally required authorization (eg, HIPAA) prior to any protocol related procedures, including screening evaluations.
You have measurable M-protein.
You have received at least 3 prior lines of therapy, including PIs, IMiDs, and anti CD38 therapies either in combination or as a single agent.
Cohort B: R/R MM Post-T-Cell Directed Therapy.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.