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Trial Title:
Anti-GD2 ADC M3554 in Advanced Solid Tumors
NCT ID:
NCT06641908
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Glioblastoma
IDH-wildtype
Soft tissue sarcomas
GD2 prevalence
targeted therapy
TOP1 inhibitor
exatecan
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
M3554
Description:
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).
Arm group label:
Dose Escalation: M3554 Monotherapy
Summary:
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
Criteria for eligibility:
Criteria:
Inclusion 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
- Exclusion 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Please Contact U.S. Medical Information
Address:
City:
Rockland
Zip:
02370
Country:
United States
Contact:
Last name:
Please Contact U.S. Medical Information
Phone:
888-275-7376
Email:
eMediUSA@emdserono.com
Facility:
Name:
Please Contact the Communication Center
Address:
City:
Darmstadt
Zip:
64293
Country:
Germany
Contact:
Last name:
Please Contact the Communication Center
Phone:
+49 6151 72 5200
Email:
service@emdgroup.com
Start date:
November 1, 2024
Completion date:
September 20, 2026
Lead sponsor:
Agency:
EMD Serono Research & Development Institute, Inc.
Agency class:
Industry
Collaborator:
Agency:
Merck KGaA, Darmstadt, Germany
Agency class:
Industry
Source:
EMD Serono
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06641908
https://clinicaltrials.emdgroup.com/en
