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Recruiting NCT05862012

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

Phase I Interventional Relapsed/Refractory Multiple Myeloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ISB 2001, ISB 2001.
Who it may be relevant to
Registry conditions: Relapsed/Refractory Multiple Myeloma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, France, India, Italy +2
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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).

Detailed description

The study enrolls 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 is conducted in two parts: Part 1 dose escalation and Part 2 dose expansion.

Dose escalation continued until the maximum planned dose was reached. Dose expansion cohorts were initiated to further confirm safety and optimal biologically active dose. Participants receive ISB 2001 until disease progression, unacceptable toxicity occurs, any criterion for stopping the study treatment, or participant withdrawal from the study.

Interventions

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

Primary outcome measures

  • Frequency and Severity Of Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to 18 months]
  • 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) [Time frame: Up to 28 days]
Secondary outcome measures (12)
  • Maximum Concentration (Cmax) of ISB 2001 in Serum [Time frame: Up to 28 days]
  • Time to Reach Maximum Concentration (Tmax) of ISB 2001 in Serum [Time frame: Up to 28 days]
  • Area Under the Concentration Time Curve in Dosing Intervals (AUC0-tau) of ISB 2001 in Serum [Time frame: Up to 28 days]
  • Area Under the Concentration Time Curve From Zero to Time t (AUC0-t) of ISB 2001 in Serum [Time frame: Up to 28 days]
  • Percent Incidence of Anti-Drug Antibody (ADA), Neutralizing Antibody (nAb) and Titer of ADA From Baseline Until End-of-Treatment (EOT) [Time frame: Baseline to 18 months]
  • Overall Response Rate (ORR) Based on International Myeloma Working Group (IMWG) [Time frame: 18 months]
  • Complete Response Rate (CRR) Based on International Myeloma Working Group (IMWG) [Time frame: 18 months]
  • Duration of Response (DOR) Based on International Myeloma Working Group (IMWG) [Time frame: 18 months]
  • Time to Progression (TTP) [Time frame: 18 months]
  • Time to Next Treatment (TTNT) [Time frame: 18 months]
  • Time to Response (TTR) [Time frame: 18 months]
  • Progression Free Survival (PFS) [Time frame: 18 months]

Eligibility criteria

Inclusion criteria

  • Participants with pathologically confirmed MM with measurable M-protein: serum and/or 24 hour urine, serum-free light chains or measurable isolated plasmacytoma
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
  • Must have adequate hematologic, hepatic, renal, and cardiac functions

Exclusion criteria

  • Active malignant central nervous system involvement
  • Uncontrolled infection requiring systemic antibiotic therapy or other serious infection prior to C1D1
  • History of autoimmune disease requiring systemic immunosuppressive therapy
  • 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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 10 centers
  • Standford Cancer Institute — Palo Alto
  • Sylvester Cancer Center — Miami
  • Winship Cancer Institute — Atlanta
  • University of Chicago Medical Center — Chicago
  • Beth Israel Deaconess Medical Center — Boston
  • Montefiore Medical Center — The Bronx
  • University of North Carolina — Chapel Hill
  • Tennessee Oncology — Nashville
  • … and 2 more centers
Australia · 5 centers
  • Concord Hospital — Concord
  • Pindara Private Hospital — Benowa
  • St. Vincent's Hospital Melbourne — Fitzroy
  • Peter MacCallum Cancer Center — Melbourne
  • Linear Clinical Research — Nedlands
India · 5 centers
  • Apollo Hospital International Limited — Gandhinagar
  • Health Care Global Enterprises Ltd. — Bangalore
  • Deenanath Mangeshkar Hospital and Research Centre — Pune
  • Apollo Cancer Centers — Hyderabad
  • HCG Hospital — Bangalore
Spain · 5 centers
  • Instituto de Investigacion Biomedica de Salamanca (IBSAL) — Salamanca
  • Institut Catala de Oncologia (ICO) — Badalona
  • Hospital Clinic de Barcelona — Barcelona
  • Centro Integral Oncologici Clara Campal — Madrid
  • Clinica Universidad de Nevarra — Pamplona
France · 4 centers
  • CHRU Lille — Lille
  • CHU Poiters - Hospital la Miletrie — Poitiers
  • CHU de Nantes - Hotel Dieu — Nantes
  • Groupe Hospitalier Pitie-Salpetriere — Paris
Italy · 2 centers
  • ASST Spedali Civili di Brescia — Brescia
  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico — Milan
Norway · 1 center
  • Oslo University Hospital — Oslo

Publications

  • Carretero-Iglesia L, Hall OJ, Berret J, Pais D, Estoppey C, Chimen M, Monney T, Loyau J, Dreyfus C, Macoin J, Perez C, Menon V, Gruber I, Laurendon A, Caro LN, Gudi GS, Matsuura T, van der Graaf PH, Blein S, Mbow ML, Croasdale-Wood R, Srivastava A, Dyson MR, Matthes T, Kaya Z, Edwards CM, Edwards JR, Maiga S, Pellat-Deceunynck C, Touzeau C, Moreau P, Konto C, Drake A, Zhukovsky EA, Perro M, Pihlgr PMID 39261676

Identifiers

NCT: NCT05862012 · ISB 2001-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗