NCT05427812

Phase 1/2 Study of ISB 1442 in Relapsed/Refractory Multiple Myeloma

A Phase 1/2, First-in-Human, Multicenter, Open-Label, Dose Escalation and Dose-Expansion Study of Single-Agent ISB 1442 in Participants With Relapsed/Refractory Multiple Myeloma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Ichnos Sciences SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The study will be conducted in two phases: * Phase 1: Dose escalation in R/R MM * Phase 2: Dose expansions in select R/R MM Participants will be treated at escalating dose levels in Phase 1 (dose-escalation phase) of the study. Once the safety of ISB 1442 is confirmed and a Recommended Phase 2 Dose (RP2D) is established in Phase 1 for a given indication, Phase 2 will be initiated for that indication. Participants will receive ISB 1442, until disease progression, unacceptable toxicity, or any criterion for stopping the study drug or withdrawal from the trial occurs.

Conditions

• Relapsed/Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	ISB 1442 SC injection escalating doses	Participants will receive escalating SC doses of ISB 1442
DRUG	ISB 1442 SC injection at RP2D	ISB 1442 SC injection dose regimen at RP2D until participants experience disease progression or unacceptable toxicity, or until any other discontinuation criterion is met

Timeline

• Start date: 2022-09-27
• Primary completion: 2024-11-19
• Completion: 2024-11-19
• First posted: 2022-06-22
• Last updated: 2025-01-17

Locations

15 sites across 3 countries: United States, Australia, India

Regulatory

• FDA-regulated drug study