ClinicaliQ Trial Snapshot
- Anti-GD2 ADC M3554 in Advanced Solid Tumors — Recruiting • Phase I • Oncology • NCT06641908.
- What is being tested: M3554 is an anti-GD2 antibody-drug conjugate (ADC) being evaluated for dose optimisation and safety assessment in patients with advanced soft tissue sarcoma and IDH-wildtype glioblastoma, with preliminary efficacy monitoring.
- Patient eligibility overview: This trial recruits adults with histologically confirmed advanced soft tissue sarcoma or glioblastoma (IDH-wildtype) who have limited or exhausted standard treatment options, typically with adequate performance status and organ function.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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
Eligibility Snapshot
- : * 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 *
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.