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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

Anti-GD2 ADC M3554 in Advanced Solid Tumors

Suzuki Tomoya

Merck Biopharma Co., Ltd.

1-3-1 Azabudai, Minato-ku, Tokyo

MBJ_clinicaltrial_information@merckgroup.com

Contact for Clinical Trial Information

Merck Biopharma Co., Ltd.

1-3-1 Azabudai, Minato-ku, Tokyo

+81-3-4316-8010

MBJ_clinicaltrial_information@merckgroup.com

Recruiting

Nov. 08, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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 systemic therapy for the metastatic setting including anthracyclines. Previous trabectidin, eribulin, pazopanib or any other drug approved for the different STS subtypes in second line (2L) or beyond will not be required for enrollment but will be allowed (for example [e.g] trabectedin, pazopanib for leiomyosarcoma (LMS); ifosfamide, gemcitabine-based combinations, trabectedin, eribulin, pazopanib for liposarcoma (LPS); trabectedin, gemcitabine, and docetaxel, pazopanib for undifferentiated pleomorphic sarcoma [UPS]). 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

- 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

Both

Advanced Solid Tumor

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).

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

+81-3-3542-2511

Nov. 05, 2024

No

USA/Belgium/France