Anti-GD2 ADC M3554 in Advanced Solid Tumors

Official title

A Phase 1, Two-Part, Multicenter, Open-Label First in Human Study of Anti-GD2 Antibody Drug Conjugate M3554 in Participants With Advanced Solid Tumors

Overview

The purpose of this study is to establish the recommended doses and further evaluate the safety and preliminary antitumor activity of M3554 in participants with soft tissue sarcoma (STS) and glioblastoma, IDH-wildtype. Study details include: Study Duration per participant: Approximately 4 months

Interventions

• Drug M3554
  M3554 will be administered at an escalated dose until Maximum tolerated dose (MTD) and/or a safe recommended Dose is determined in participants with STS (dose escalation A) and glioblastoma and IDH wildtype (dose escalation B).

Primary outcome measures

• Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs) [Time frame: up to 4 months]

Secondary outcome measures (5)

• Pharmacokinetic (PK) Plasma Concentrations of M3554 [Time frame: Cycle 1 Day 1 to Cycle 3 Day 15 and every second cycle from Cycle 4 (each cycle is of 21 days), assessed up to approximately 4 months]
• Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 or Response Assessment in Neuro-oncology (RANO) 2.0 as Assessed by Investigator [Time frame: Time from randomization to planned assessment at 4 months]
• Duration of Response (DoR) According to RECIST Version 1.1 or RANO 2.0 as Assessed by Investigator [Time frame: Time from randomization to planned assessment at 4 months]
• Progression-free Survival (PFS) According to RECIST Version 1.1 or RANO 2.0 as Assessed by Investigator [Time frame: Time from randomization to planned assessment at 4 months]
• Change from Baseline in Corrected QT Interval (QTc) Interval [Time frame: Pre-dose on Day 1 (baseline) up to 24 hours post-dose Day 1, Day 2, Day 5, Day 8 of Cycle 1 and Cycle 3 Day 1 (each Cycle is 21 days)]

Eligibility criteria

Inclusion criteria

• Escalation A: participants with documented histopathological diagnosis of locally advanced or metastatic STS with unresectable disease that has progressed after at least one prior line of anthracycline-containing systemic therapy for the locally advanced/metastatic setting.
• Participants with resectable locally advanced or metastatic disease, who had surgery before study entry will be allowed in the trial if there is residual disease after surgery and if the surgery was performed at least 4 weeks before first dose of study intervention.
• Escalation B: participants with documented histopathological diagnosis of glioblastoma, IDH-wildtype, who have progressed after ONLY one prior line of therapy (including radiotherapy +/- temozolomide, depending on the O\^6-methylguanine-DNA methyltransferase \[MGMT\] status) and relapsing at least 3 months after the end of the radiotherapy treatment.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) below or equal to 1
• Participants with adequate hematologic, hepatic and renal function as defined in protocol
• Other protocol defined inclusion criteria could apply

• Exclusion Criteria:
• Participant has a history of malignancy other than STS or glioblastoma (depending on the escalation/expansion cohort) within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hypertropia, or malignancy that in the opinion of the Investigator, is considered cured with minimal risk of recurrence within 3 years).
• STS only: Participants with history of brain metastasis, leptomeningeal metastasis, or participants with spinal cord compression
• Other protocol defined exclusion criteria could apply

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

Healthy volunteers: No

Study design

Allocation

N/A

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

France · 4 centers

• Institut Bergonié - Service d'Oncologie Médicale — Bordeaux
• Centre Oscar Lambret - cancerologie generale — Lille
• Centre Leon Berard - Service d'Oncologie Medicale — Lyon
• Centre Antoine Lacassagne - Service d'Hématologie Oncologie — Nice

United States · 3 centers

• Dana-Farber Cancer Institute — Boston
• Memorial Sloan-Kettering Cancer Center (MSKCC) - New York - Memorial Sloan Kettering Cance — New York
• The University of Texas MD Anderson Cancer Center — Houston

Belgium · 1 center

• UZ Leuven — Leuven

Japan · 1 center

• National Cancer Center Hospital — Chūōku

Switzerland · 1 center

• Universitaetsspital Zuerich - Klinik fuer Neurologie — Zurich

United Kingdom · 1 center

• Royal Marsden Hospital-Sutton - Dept of Oncology (Surrey) — Sutton

Identifiers

NCT: NCT06641908 · MS201460_0001 · 2024-513687-26-00 · jRCT2031240430

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗