Anti-GD2 ADC M3554 in Advanced Solid Tumors

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
EMD Serono Research & Development Institute, Inc.
Study ID
NCT06641908
Phase
PHASE1
Status
Recruiting

Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • M3554 — DRUG
    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).

Study Details

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

Key Dates

Start date
Nov 8, 2024
Status verified
May 2026
Primary completion
Apr 16, 2027
Completion
Apr 16, 2027

Study Design

Enrollment
52 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation: M3554 Monotherapy

Primary Outcome Measure

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

Central Contacts

Locations (3)

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