About this trial
The purpose of this study is to find out whether 177Lu-DTPA-SC16.56 is a safe treatment for people with small-cell lung cancer or neuroendocrine prostate cancer
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects with histologically proven progressive metastatic high-grade neuroendocrine carcinomas of the lung (small-cell lung cancer) and prostate (neuroendocrine prostate cancer) that has relapsed following at least 1 line of standard chemotherapy i. Prostate cancer patients will be defined by either of the following criteria: ii. The presence of chromogranin staining on tissue iii. At least two of the pathogenic mutations of PTEN, RB1, or p53 iv. Disease exclusively involving the viscera v. Disease in which the PSA is <10 but the number of bone lesions is >20 vi. Histologic evidence of small cell carcinoma or other stains consistent with neuroendocrine disease (on the primary disease or metastases) vii. DLL3 positivity on previously available tissue specimens
Ability to understand and willingness to sign a written informed consent document
Aged 18 years or older at the time of signing consent
At least one tumor lesion on CT or MR ≥ 2 cm
Disqualifiers
History of anaphylactic reaction to humanized or human antibodies
History of severe allergic reaction to X-ray contrast medium despite premedication
Prior treatment with Rova-T (rovalpituzumab)
Women who are pregnant or unwilling to discontinue breastfeeding
Trial design
Parallel
Treatments tested in this trial
PET/CT
Diagnostic testParticipants will undergo 89Zr-DFO-SC16.56 Ab PET/CT
177Lu-DTPA-SC16.56
Biological/Vaccine177Lu-DTPA-SC16.56, to be administered within 2 weeks of the PET/CT
Treatment groups
Trial outcomes
Primary outcomes
Maximum tolerated dose of 177Lu-DTPA-SC16.56
Evaluating the safety and defining the MTD of 177Lu-DTPA-SC16.56 radiopharmaceutical therapy (RPT).
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: