Anti-GD2 ADC M3554 in Advanced Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEMD Serono Research & Development Institute, Inc.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
M3554
DrugM3554 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).
Treatment groups
65 Participants
are divided into 1 treatment groupGroup A: Dose Escalation: M3554 MonotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs)
Time frame
up to 4 monthsSecondary outcomes
1
Pharmacokinetic (PK) Plasma Concentrations of M3554
Time frame
Cycle 1 Day 1 to Cycle 3 Day 15 and every second cycle from Cycle 4 (each cycle is of 21 days), assessed up to approximately 4 months2
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
Time frame
Time from randomization to planned assessment at 4 months3
Duration of Response (DoR) According to RECIST Version 1.1 or RANO 2.0 as Assessed by Investigator
Time frame
Time from randomization to planned assessment at 4 months4
Progression-free Survival (PFS) According to RECIST Version 1.1 or RANO 2.0 as Assessed by Investigator
Time frame
Time from randomization to planned assessment at 4 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
EMD Serono Research & Development Institute, Inc.
Lead sponsor
Merck KGaA, Darmstadt, Germany
Collaborator
Source ClinicalTrials.gov