A Phase 1 interventional study of 131 I-8H9 in Peritoneal Cancer, sponsored by Y-mAbs Therapeutics. Terminated at 1 site in United States. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2023-10-31.
Sponsored by Y-mAbs Therapeutics · Phase 1, Interventional, and Treatment
A phase I study of Intraperitoneal Radioimmunotherapy with 131 I-omburtamab in patients >1 year of age with desmoplastic small round cell tumors and other solid tumors involving the peritoneum.
The purpose of this study is to test the safety of a new medicine called antibody 8H9 injected into the lining of the abdomen or peritoneum, where the tumor is. This medicine is an antibody or protein which binds to certain tumors, including DSCRT. There is a small number of DSCRT which do not bind with 8H9. If the tumor does not bind with 8H9, you might not benefit from this treatment. The investigators want to find out what effects, good and/or bad, it has.
This antibody is made in mice. Radioactive iodine can be bound to this antibody to deliver radiation to the tumor. The investigators wish to determine the safety of radiolabeled 8H9 at different dose levels. This is the first study using 131I-8H9 in the peritoneum.
47 studies on the registry are indexed under Desmoplastic Small Round Cell Tumor; 14 are open to participants now.
This study's enrollment of 54 is above the median of 31 across 39 interventional studies indexed under Desmoplastic Small Round Cell Tumor.
Browse Desmoplastic Small Round Cell Tumor studies →Y-mAbs Therapeutics is the lead sponsor of 15 studies on the registry; none are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
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Exclusion Criteria:
This is a phase I study of 131I-8H9 for patients with DSRCT and other 8H9-reactive solid tumors metastatic to the peritoneum.
Biological: 131 I-8H9
Patients will be administered therapeutic dose of IP 131I-8H9 per the dose escalation regimen. 131I-8H9 pharmacokinetics will be studied by serial blood draws from indwelling venous lines. 131I-8H9 biodistribution will be studied by a single gamma camera scan about 5 days after IP injection where feasible.
Define the toxicity of 131I-8H9 administered intraperitoneally.
Assessment of toxicity of 131I-8H9 administered intraperitoneally.
Time frame: weekly
Define maximal tolerated dose (MTD) of 131I-8H9 administered intraperitoneally
Assessment of maximal tolerated dose of 131I-8H9 administered intraperitoneally
Time frame: 5 years
Assess pharmacokinetics for 131I-8H9 administered intraperitoneally
Assessment of the pharmacokinetics for IP 131I-8H9 administered intraperitoneally
Time frame: 0 hrs, 60 mins, 2 hrs, 8 hrs, 18hrs, 30 hrs, 42hr, 66hrs, 90 hrs, and 114hrs.
Assess response of DSRCT and other solid tumors to 131 I-8H9 administered intraperitoneally
Assessment of the response of DSRCT and other solid tumors to 131 I-8H9 administered intraperitoneally
Time frame: between days 24 and 38
Plan to share: No
This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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