An Early Phase 1 interventional study of 211-astatine MX35 F(ab')2 in Ovarian Cancer, sponsored by Vastra Gotaland Region. Completed at 1 site in Sweden. Open to female participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-07-08.
Sponsored by Vastra Gotaland Region · Early Phase 1, Interventional, and Treatment
In this alpha-radioimmunotherapy study groups of 3 patients with recurring epithelial ovarian cancer treated by salvage chemo-therapy and being in complete or good partial remission will receive one intra peritoneal infusion of 211 astatine (211At)-MX35 F(ab')2 . Patients will receive a single dose of MX35 F(ab')2 radiolabeled with increasing activity concentration of 211At in 1.0 - 2 L Extraneal® solution starting at an activity concentration of 50 megabecquerel per litre (MBq/L).
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 12 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Vastra Gotaland Region is the lead sponsor of 267 studies on the registry; 107 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The following laboratory and clinical results within 2 weeks prior to first study day:
Absolute neutrophil count (ANC) > 1.5 x 109/L Platelet count > 100 x 109/L Serum bilirubin \< upper limit of normal(ULN) Aspartate aminotransaminase (ASAT) \< 1.5 x ULN Serum aminotransferase (ALAT) \< 1.5 x ULN Serum creatinine \< 1.5 x upper limit of normal Thyreoglobulin baseline information Thyroid-stimulating hormone (TSH) baseline information T4 baseline information
Exclusion Criteria:
Four groups of 3 patients with recurring ovarian cancer treated by salvage chemo-therapy and being in complete or good partial remission will receive one IP dose of 211astatine-MX35 F(ab'2). Starting at 50 MBq/L. Dose escalation 100 Mbq/L, 200 MBq/L and finally 300 MBq/L.
Combination Product: 211-astatine MX35 F(ab')2
Alpha emitting radionuclide 211At conjugated to monoclonal antibody MX35 F(ab')2. Targeting the sodium phosphate transporter (NaPi2b).
Maximum observed concentration (Cmax) of Astatine 211
Decay corrected activity concentration in serum, intraperitoneal fluid and urine.
Time frame: Sampled from +1 hour to +48 hrs post infusion.
Area under the curve (AUC) of astatine 211 from time of dosing to 48 hrs after dosing
Decay corrected activity concentration in serum, intraperitoneal fluid and urine, including actual imaging quantification on gamma-Camera scintigraphy.
Time frame: Sampled from +1 hour to +48 hrs post infusion.
Toxicity: hematology, liver, kidney, thyroid function
As defined by NCI Common Toxicity Criteria v2.0
Time frame: From procedure start (implantation of catheter) to 8 weeks after infusion
Plan to share: No — Upun specific request, data could be considered to be shared.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Vastra Gotaland Region