Study of 177Lu-DTPA-SC16.56 for Lung and Prostate Neuroendocrine Carcinomas
This study is testing a treatment called 177Lu-DTPA-SC16.56 for people with advanced small-cell lung cancer or neuroendocrine prostate cancer. You might be able to join if your cancer has progressed after at least one round of standard chemotherapy. Before treatment, you will have a special scan called a PET/CT using 89Zr-DFO-SC16.56 Ab. The main goal of this study is to find the highest safe dose of 177Lu-DTPA-SC16.56. The study is currently unclear about its recruitment status and plans to enroll 12 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 12 participants.
- What's involved
- You will undergo a PET/CT scan using 89Zr-DFO-SC16.56 Ab, and then receive 177Lu-DTPA-SC16.56 within two weeks of the scan.
- Compensation
- Not stated in the trial record.
- Follow-up
- The maximum tolerated dose will be measured for up to 36 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06941480
A Study of 177Lu-DTPA-SC16.56 in People With Neuroendocrine Carcinomas of the Lung and Prostate
Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~12 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:PET/CT177Lu-DTPA-SC16.56
At a glance
Recruiting sites
0 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose of 177Lu-DTPA-SC16.56
Measured over Up to 36 months
Conditions
Where it's being run
7 sites across 2 statesNew York4
New Jersey3
Study leadership
- Lisa Bodei, MD, PhD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Progression of disease defined by one of the following occurring within 3 months of study entry:
At least one tumor lesion on CT or MR ≥ 2 cm
ECOG performance status 0 to 2
Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
Previous chemotherapy, immunotherapy, and/or investigational agents are allowed if completed ≥4 weeks prior to study entry. For patients who received systemic therapy prior to study entry, there must be documented progression of measurable disease since receiving systemic therapy prior to study entry.
Preserved hematological function:
Preserved renal function:
Preserved hepatic function:
Willingness to undergo baseline and follow up biopsy to obtain tissue for DLL3 IHC and genomic analyses
In order to proceed with the treatment with 177Lu-DTPA-SC16.56, patients must exhibit overexpression of DLL3, as SUVmax greater than in normal liver, in ≥80% of tumor lesions among the growing progressing lesions that are ≥2cm.
Major surgery within 28 days of enrolment with the exception of biopsy and insertion of central venous catheter.
Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Known parenchymal brain metastases and/or carcinomatous meningitis, unless these metastases have been treated and stabilized.
Unmanageable urinary incontinence rendering the administration of 177Lu-DTPA-SC16.56 unsafe (e.g., urinary catheterization not feasible).
Other ongoing invasive malignances (i.e., not carcinomas in situ, non-mm invasive urothelial cancer, or other non-invasive tumors), and prior cancers that have been treated that have a \>30% likelihood of relapse within the next two years.
Subjects likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject's and investigator's knowledge.
Prostate cancer patients with mixed histologies (i.e., neuroendocrine and adenocarcinomas) are eligible provided that they meet all of the above eligibility criteria.
Patients for whom their clinicians believe would benefit by continuing their treatments for their disease to control any adenocarcinoma (such as ADT or other AR axis directed therapy) can and should remain on those treatments while on this protocol, if their clinician believes that it would be clinically beneficial to do so.
Concurrent chemotherapy, other radiopharmaceuticals of any type, and immunotherapy are excluded
Complementary approaches known to modulate PSA should not be taken while on this trial
Exclusion
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
Spinal cord compression or symptomatic/uncontrolled epidural disease, unless treated and stable for at least 1 week prior to enrolment.
Males and females of reproductive potential who are unwilling to practice a highly effective method(s) of birth control while on study through 4 months for males and 7 months for females after receiving the therapeutic study drug. Acceptable methods of highly effective birth control include sexual abstinence (males, females); vasectomy; bilateral tubal ligation/occlusion; or a condom with spermicide (men) in combination with hormonal birth control or intrauterine device (IUD) (women)
Life expectancy \< 6 months as assessed by the treating physician.
What this trial measures
- Maximum tolerated dose of 177Lu-DTPA-SC16.56Up to 36 months
Evaluating the safety and defining the MTD of 177Lu-DTPA-SC16.56 radiopharmaceutical therapy (RPT).