A Study of 177Lu-DTPA-SC16.56 in People With Neuroendocrine Carcinomas of the Lung and Prostate
Characterizing the Theranostic Potential of DLL3-targeting Agents in High-grade Neuroendocrine Carcinomas of the Lung and Prostate
1 other identifier
interventional
12
1 country
7
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2026
Longer than P75 for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2025
CompletedFirst Posted
Study publicly available on registry
April 23, 2025
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2030
Study Completion
Last participant's last visit for all outcomes
May 1, 2030
April 14, 2026
April 1, 2026
3.9 years
April 16, 2025
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum tolerated dose of 177Lu-DTPA-SC16.56
Evaluating the safety and defining the MTD of 177Lu-DTPA-SC16.56 radiopharmaceutical therapy (RPT).
Up to 36 months
Study Arms (2)
Participants with neuroendocrine carcinomas of the lung
EXPERIMENTALParticipants with neuroendocrine prostate cancer
EXPERIMENTALInterventions
Participants will undergo 89Zr-DFO-SC16.56 Ab PET/CT
177Lu-DTPA-SC16.56, to be administered within 2 weeks of the PET/CT
Eligibility Criteria
You may qualify if:
- 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:
- i. At least a 20% increase in radiologically or clinically measurable disease; ii. Appearance of any new lesion; iii. For prostate cancer patients progression criteria will be per PCWG3: iv. Either v. A rising PSA over a sequence of at least 1-week intervals OR i. An increase in soft tissue disease to qualify for disease progression by RECIST 1.1 OR ii. Two new bone lesions by bone scintigraphy
- Patients with metastatic disease by virtue of disease exclusively evident by PSMA PET will not be eligible. All patients must have metastatic disease by evidence of standard scintigraphic or anatomic imaging in accord with PCWG3
- 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:
- i. Hb ≥9.0 g/dL; ii. WBC ≥3000/mm3; iii. ANC≥1500/mm3; iv. Platelets ≥75.000/mm3
- Preserved renal function:
- i. Serum creatinine ≤1.7 mg/dL ii. Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73m2
- Preserved hepatic function:
- +3 more criteria
You may not qualify if:
- 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.
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Cancer Center Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa Bodei, MD, PhD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2025
First Posted
April 23, 2025
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
May 1, 2030
Study Completion (Estimated)
May 1, 2030
Last Updated
April 14, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.