Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)

Part of paid clinical trials in Palo Alto, California.

Sponsor
Ichnos Sciences SA
Study ID
NCT05862012
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ISB 2001 — DRUG
    Participants receive escalating doses of ISB 2001
  • ISB 2001 — DRUG
    Participants receive injection of ISB 2001 as determined in Part 1.

Study Details

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).

Key Dates

Start date
Nov 1, 2023
Status verified
Mar 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Dose Escalation
    Participants with R/R MM is administered ISB 2001 weekly on Days 1, 8, 15, and 22 of each 28-day cycle, with an additional step-up dose in Cycle 1 on Day 4. Treatment cycle duration is 28 days. Participants will receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment or participant withdrawal from the study
  • Experimental: Part 2: Dose Expansion
    Dose expansion cohorts are 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.

Primary Outcome Measure

Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to 18 months ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Standford Cancer InstitutePalo AltoCalifornia94304
Michaela Liedtke
[email protected]
650-723-0501
Sylvester Cancer CenterMiamiFlorida33136-
Winship Cancer InstituteAtlantaGeorgia30322
Nishi Shah, MD
[email protected]
404-778-0659
University of Chicago Medical CenterChicagoIllinois60637
Benjamin Derman, MD
[email protected]
8472758131
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Shonali Midha, MD
[email protected]
617-632-2104
Montefiore Medical CenterThe BronxNew York10467
David Levitz
[email protected]
860-918-6192
University of North CarolinaChapel HillNorth Carolina27599
Eben Lichtman
[email protected]
6178426051
Tennessee OncologyNashvilleTennessee37203-
Virginia Commonwealth University (VCU)RichmondVirginia23298-
Froedtert Hospital & the Medical College of WisconsinMilwaukeeWisconsin53226
Binod Dhakal, MD
[email protected]
4148054600

Find similar trials in Palo Alto, CA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Standford Cancer Institute· Palo Alto, CASylvester Cancer Center· Miami, FLWinship Cancer Institute· Atlanta, GAUniversity of Chicago Medical Center· Chicago, ILBeth Israel Deaconess Medical Center· Boston, MAMontefiore Medical Center· The Bronx, NY

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