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Monoclonal Antibodies
131 I-8H9 for Peritoneal Neoplasm
Phase 1
Waitlist Available
Led By Shakeel Modak, MD
Research Sponsored by Y-mAbs Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial will test the safety of a new antibody medicine injected into the abdominal cavity to treat certain tumors, and if it has any effects, good or bad.
Eligible Conditions
- Peritoneal Neoplasm
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Define the toxicity of 131I-8H9 administered intraperitoneally.
Secondary outcome measures
Assess pharmacokinetics for 131I-8H9 administered intraperitoneally
Assess response of DSRCT and other solid tumors to 131 I-8H9 administered intraperitoneally
Define maximal tolerated dose (MTD) of 131I-8H9 administered intraperitoneally
Trial Design
1Treatment groups
Experimental Treatment
Group I: 131 I-8H9Experimental Treatment1 Intervention
This is a phase I study of 131I-8H9 for patients with DSRCT and other 8H9-reactive solid tumors metastatic to the peritoneum.
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Who is running the clinical trial?
Y-mAbs TherapeuticsLead Sponsor
25 Previous Clinical Trials
1,503 Total Patients Enrolled
Shakeel Modak, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
9 Previous Clinical Trials
330 Total Patients Enrolled
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