Anti-GD2 Antibody Drug Conjugate M3554 in Advanced Solid Tumors
Zusammenfassung der Studie
The aim of this study is to investigate the safety, tolerability, pharmacokinetics, and preliminary clinical activity of M3554 in patients with soft tissue sarcoma (STS) and glioblastoma (GBM), IDH-wildtype. M3554 is an investigational drug being studied in this Phase I trial for first use in humans for the treatment of patients with advanced solid tumors. Participants will be treated until disease progression, occurrence of toxicity, death, withdrawal, or the end of the study. A total of approximately 160 participants are planned to be enrolled in the study across 6 countries. This includes: 30 participants with STS in the dose escalation of Phase Ia; 20 participants with glioblastoma in the dose escalation of Phase Ia; 80 participants with STS in the dose expansion of Phase Ib; and 30 participants with glioblastoma in the dose expansion of Phase Ib. The average duration of participation in Phase Ia is approximately 4 months and in Phase Ib approximately 6 months.
(BASEC)
Untersuchte Intervention
This research study consists of two parts, in which the study drug will be investigated in patients with locally advanced/metastatic soft tissue sarcoma and glioblastoma. Phase Ia: Dose escalation (starting with a small dose of the study drug that is then slowly increased over time) to establish the recommended dose, and Phase Ib: Dose expansion, where the study drug is further investigated at a specific dose strength to learn more about how it works and how well it is tolerated by patients. The pre-screening period begins before the administration of the first dose of the study drug and lasts up to 28 days. Participants will be enrolled in either Dose Level A or Dose Level B depending on the type of tumor (STS or GBM). The treatment period is expected to include approximately 4-6 treatment cycles and will depend on the response to the study drug. The study drug will be administered as an intravenous infusion on Day 1 of each cycle in consecutive 21-day cycles (every 3 weeks). After the treatment period, a visit for treatment completion and a visit for safety follow-up/post-treatment discontinuation are planned.
(BASEC)
Untersuchte Krankheit(en)
Advanced Solid Tumor
(BASEC)
We are looking for participants who are older than 18 years, with: - a documented histopathological diagnosis: o a locally advanced or metastatic unresectable soft tissue sarcoma that has progressed after at least one prior systemic therapy line for the treatment of metastases, including anthracyclines, or o a glioblastoma, IDH-wildtype, that has progressed after only one prior therapy line, including radiotherapy +/- temozolomide, and has recurred (re-occurred) ≥ 3 months after radiotherapy; - an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1. (BASEC)
Ausschlusskriterien
• Adverse events related to prior therapies that have not improved to Grade ≤ 1 according to the criteria per NCI-CTCAE Version 5.0 (exceptions apply); participants with neurotoxicity Grade ≥ 3 due to prior treatments in their history; participants with neurotoxicity Grade 1 due to prior cancer therapies at baseline assessment. • Participants with another malignant disease other than soft tissue sarcoma or glioblastoma (depending on the dose escalation/dose expansion group) within 3 years prior to the enrollment date in their history (exceptions are squamous cell and basal cell carcinoma of the skin and cervical carcinoma in situ, benign prostatic neoplasia/prostate hyperplasia, or malignant diseases that are considered cured by the investigator and for which there is only a minimal risk of recurrence [relapse] within 3 years). • Only for STS: Participants with brain metastases or leptomeningeal metastases in their history or participants with spinal cord compression. (BASEC)
Studienstandort
Zürich
(BASEC)
Sponsor
Merck Healthcare KGaA IQVIA AG, Branch Basel
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Michael Weller, Prof. Dr. med.
+41 44 255 55 00
michael.weller@clutterusz.chUniversitätsspital Zürich, Klinik für Neurologie Frauenklinikstrasse 26, 8091 Zürich
(BASEC)
Allgemeine Auskünfte
EMD Serono Research & Development Institute, Inc.
888-275-7376
eMediUSA@emdserono.com(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
09.09.2025
(BASEC)
ICTRP Studien-ID
NCT06641908 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
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 (BASEC)
Wissenschaftlicher Titel
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 (ICTRP)
Öffentlicher Titel
Anti-GD2 ADC M3554 in Advanced Solid Tumors (ICTRP)
Untersuchte Krankheit(en)
Advanced Solid Tumor (ICTRP)
Untersuchte Intervention
Drug: M3554 (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: N/A. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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 (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs) (ICTRP)
Pharmacokinetic (PK) Plasma Concentrations of M3554;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;Duration of Response (DoR) According to RECIST Version 1.1 or RANO 2.0 as Assessed by Investigator;Progression-free Survival (PFS) According to RECIST Version 1.1 or RANO 2.0 as Assessed by Investigator;Change from Baseline in Corrected QT Interval (QTc) Interval (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany (ICTRP)
Weitere Kontakte
Medical ResponsibleUS Medical Information, eMediUSA@emdserono.com, 888-275-7376, EMD Serono Research & Development Institute, Inc. (ICTRP)
Sekundäre IDs
2024-513687-26-00, MS201460_0001 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT06641908 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar