177Lu-DTPA-SC16.56 for Lung and Prostate Cancer

Not yet recruiting at 6 trial locations

Overseen By Michael Morris, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Chemotherapy, Radiopharmaceuticals, Immunotherapy

Disqualifiers: Anaphylactic reactions, Brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 36 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called 177Lu-DTPA-SC16.56, a radiopharmaceutical therapy, to determine its safety for individuals with certain types of lung and prostate cancer. It targets small-cell lung cancer and neuroendocrine prostate cancer that have recurred after standard chemotherapy. Suitable candidates have these cancer types, have experienced recent progression, and possess specific tumor markers. The trial aims to assess whether this treatment can safely manage their cancer. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot take concurrent chemotherapy, other radiopharmaceuticals, or immunotherapy during the trial. If you are on treatments for adenocarcinoma, you may continue them if your doctor thinks it's beneficial.

Is there any evidence suggesting that 177Lu-DTPA-SC16.56 is likely to be safe for humans?

Research has shown that 177Lu-DTPA-SC16.56 might be a safe treatment based on early studies. Tests with mice indicated effectiveness and manageable side effects for small-cell lung cancer. For neuroendocrine prostate cancer, similar treatments in early human studies were well-tolerated, with no major safety issues.

As a Phase 1 trial, the primary goal is to assess safety. This trial marks the first time the treatment is tested in humans. Although limited safety data exists for humans, early studies suggest it could be safe for further testing. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lung and prostate cancer?

Researchers are excited about 177Lu-DTPA-SC16.56 because it offers a novel approach to treating neuroendocrine carcinomas of the lung and prostate. Unlike traditional therapies such as chemotherapy and hormone treatments, which have broad effects, 177Lu-DTPA-SC16.56 is a targeted radiopharmaceutical. It delivers radiation directly to cancer cells, potentially minimizing damage to healthy tissues. This precision targeting could lead to fewer side effects and improved outcomes for patients, setting it apart from existing options.

What evidence suggests that 177Lu-DTPA-SC16.56 might be an effective treatment for lung and prostate cancer?

Research shows that 177Lu-DTPA-SC16.56 may help treat certain difficult-to-manage lung and prostate cancers. In this trial, participants with neuroendocrine carcinomas of the lung and neuroendocrine prostate cancer will receive 177Lu-DTPA-SC16.56. A similar treatment, 177Lu-DTPA-SC16, proved effective for prostate cancer with neuroendocrine features. Specifically, patients whose tumors had more than 1% of a protein called DLL3 responded to the treatment 22.2% of the time. This suggests that targeting DLL3, found on the surface of these cancer cells, might be crucial for the treatment's success. Additionally, studies in mice with small-cell lung cancer showed positive results using this method. While research continues, these early findings offer hope for treating these challenging cancers. ^{1 3 4 5 6}

Who Is on the Research Team?

Lisa Bodei, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with specific types of cancer: small-cell lung cancer or neuroendocrine prostate cancer. The detailed eligibility criteria are not provided, but typically participants must meet certain health standards and have a confirmed diagnosis.

Inclusion Criteria

Ability to understand and willingness to sign a written informed consent document

I am willing to have biopsies before and during the trial.

My blood, kidney, and liver functions are normal.

Exclusion Criteria

I have severe urinary incontinence making certain cancer treatments unsafe.

My brain metastases or carcinomatous meningitis is treated and stable.

History of anaphylactic reaction to humanized or human antibodies

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 177Lu-DTPA-SC16.56 to evaluate safety and define the maximum tolerated dose

36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 177Lu-DTPA-SC16.56

Trial Overview The study is testing the safety of a treatment called 177Lu-DTPA-SC16.56 in patients with either small-cell lung cancer or neuroendocrine prostate cancer. Participants will undergo PET/CT scans to monitor the effects.

How Is the Trial Designed?

Group I: Participants with neuroendocrine prostate cancer Experimental Treatment 2 Interventions

Group II: Participants with neuroendocrine carcinomas of the lung Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

Lutetium-177 (177Lu) radiopharmaceuticals are increasingly used for treating metastatic neuroendocrine tumors and prostate adenocarcinoma, highlighting their growing importance in targeted cancer therapies.

The paper emphasizes the need for patient-specific dosimetry to optimize treatment effectiveness and minimize radiation-induced side effects on normal tissues, providing guidance on dosimetry methods for various organs and tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EANM dosimetry committee recommendations for dosimetry of 177Lu-labelled somatostatin-receptor- and PSMA-targeting ligands. Sjögreen Gleisner, K., Chouin, N., Gabina, PM., et al.[2022]

The UpFrontPSMA trial is evaluating the effectiveness and safety of combining lutetium-177 (177 Lu)-PSMA-617 with docetaxel in 140 men with newly diagnosed metastatic hormone-naïve prostate cancer, aiming to determine the proportion of patients achieving undetectable PSA levels after 12 months.

This study is significant as it compares the experimental treatment to standard docetaxel therapy while all patients receive continuous androgen deprivation therapy, potentially providing insights into improved treatment strategies for this aggressive cancer type.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

UpFrontPSMA: a randomized phase 2 study of sequential 177 Lu-PSMA-617 and docetaxel vs docetaxel in metastatic hormone-naïve prostate cancer (clinical trial protocol). Dhiantravan, N., Emmett, L., Joshua, AM., et al.[2021]

Lutetium-177 labeled radiopharmaceuticals, specifically 177Lu-EDTMP and 177Lu-DOTA-TATE, have shown promising efficacy in treating bone pain from metastatic cancer and neuroendocrine tumors, with no serious adverse effects reported even in patients with renal disease.

In a study involving 13 patients, 177Lu-EDTMP demonstrated high and rapid uptake in bone metastases, while 177Lu-DOTA-TATE resulted in partial remissions in 4 out of 5 patients, indicating effective therapeutic responses without significant renal impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

¹⁷⁷Lu-Labeled Agents for Neuroendocrine Tumor Therapy and Bone Pain Palliation in Uruguay. Balter, H., Victoria, T., Mariella, T., et al.[2019]

177Lu-DTPA-SC16, a targeted radioimmunotherapy for neuroendocrine prostate cancer (NEPC), showed high specificity and efficacy in preclinical models, achieving complete tumor responses in 63% of treated mice at the lowest dose tested.

The treatment was generally safe, with only transient drops in hematologic parameters observed, which returned to normal levels by week 4, indicating a favorable safety profile for potential human trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delta-like ligand 3-targeted radioimmunotherapy for neuroendocrine prostate cancer. Korsen, JA., Gutierrez, JA., Tully, KM., et al.[2023]

Treatment with lutetium-177 (177Lu)-prostate-specific membrane antigen (PSMA) significantly reduces prostate-specific antigen (PSA) levels in patients with advanced metastatic prostate cancer, especially after the first treatment cycle.

The therapy shows a beneficial effect on reducing lymph node metastasis, while also indicating potential negative impacts on visceral metastasis, highlighting its efficacy in managing certain aspects of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Advanced Metastatic Prostate Cancer Using Molecular-Targeted Therapy: Radioligand Lutetium-177 Prostate-Specific Membrane Antigen. Rathore, R., Rangrej, SB., Kieme, I., et al.[2023]

In a phase 2 trial involving 30 men with metastatic castration-resistant prostate cancer, 57% achieved a significant PSA decline of 50% or more after treatment with Lutetium-177 [177Lu]-PSMA-617, indicating its efficacy in this patient population.

The treatment was associated with low toxicity, with the most common side effects being mild dry mouth and transient nausea, and it also led to clinically meaningful improvements in pain and quality of life for many patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[177Lu]-PSMA-617 radionuclide treatment in patients with metastatic castration-resistant prostate cancer (LuPSMA trial): a single-centre, single-arm, phase 2 study. Hofman, MS., Violet, J., Hicks, RJ., et al.[2021]

In a study of 125 men with metastatic castrate-resistant prostate cancer treated with 177LuPSMA, personalizing treatment intervals based on early response biomarkers (PSA and SPECT imaging) led to improved progression-free survival (PFS) and overall survival (OS), with a median OS of 16.8 months overall.

The study found that 35% of patients could take treatment breaks after showing a marked response, resulting in a median PFS of 12.1 months for this group, compared to shorter PFS for those with less favorable responses, highlighting the potential for tailored treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient outcomes following a response biomarker-guided approach to treatment using 177Lu-PSMA-I&T in men with metastatic castrate-resistant prostate cancer (Re-SPECT). Emmett, L., John, N., Pathmanandavel, S., et al.[2023]

In a patient with metastatic castration-resistant prostate cancer (mCRPC), four cycles of radioligand therapy (RLT) using 177Lu-PSMA I&T resulted in over 97% destruction of metastatic tumors, indicating high efficacy of this treatment.

The study highlights the need for individualized dosimetry to account for variations in tumor response and suggests that measuring 177Lu-PSMA activity concentrations could improve routine dosimetry practices, while also noting that the first cycle of RLT has the most significant impact on treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiomics Analysis for 177Lu-DOTAGA-(l-y)fk(Sub-KuE) Targeted Radioligand Therapy Dosimetry in Metastatic Prostate Cancer-A Model Based on Clinical Example. Kelk, E., Ruuge, P., Rohtla, K., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06941480

NCT06941480 | A Study of 177Lu-DTPA-SC16.56 in ... 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 ...

2. withpower.com withpower.com/trial/phase-1-neuroendocrine-carcinoma-of-lung-4-2025-faddb

177Lu-DTPA-SC16.56 for Lung and Prostate Cancer Research on a similar treatment, 177Lu-DTPA-SC16, showed it was effective in treating a specific type of prostate cancer (neuroendocrine prostate cancer) in ...

3. theranostictrials.org theranostictrials.org/studies/cl74bp9il0261ajjfrm1lc6fe/study/NCT06941480

NCT06941480 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.

4. trials.teamjackfoundation.org trials.teamjackfoundation.org/trials/NCT06941480

A Study of 177Lu-DTPA-SC16.56 in People With Neuroendocrine ... A Study of 177Lu-DTPA-SC16.56 in People With Neuroendocrine Carcinomas of the Lung and Prostate. Study Purpose. The purpose of this study is to find out whether ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8976830/

Radioimmunotherapy Targeting Delta-like Ligand 3 in ... Herein, we report the preclinical efficacy and toxicity of 177Lu-labeled SC16 ([177Lu]Lu-DTPA-CHX-A”-SC16) for treatment of human SCLC in tumor-bearing mice.

6. clin.larvol.com clin.larvol.com/trial-detail/NCT06941480

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