A Study of 177Lu-DTPA-SC16.56 in People With Neuroendocrine Carcinomas of the Lung and Prostate

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • PET/CT

    Diagnostic test

    Participants will undergo 89Zr-DFO-SC16.56 Ab PET/CT

  • 177Lu-DTPA-SC16.56

    Biological/Vaccine

    177Lu-DTPA-SC16.56, to be administered within 2 weeks of the PET/CT

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: Participants with neuroendocrine carcinomas of the lungExperimental treatment 2 interventions
Group B: Participants with neuroendocrine prostate cancerExperimental treatment 2 interventions

Trial outcomes

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).

Time frame
Up to 36 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: