NIPH Clinical Trials Search

Anti-GD2 ADC M3554 in Advanced Solid Tumors

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Advanced Solid Tumor
Date of first enrollment	08/11/2024
Target sample size	40
Countries of recruitment	USA,Japan,Belgium,Japan,France,Japan
Study type	Interventional
Intervention(s)	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).

Outcome(s)

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

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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 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
Exclude 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