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

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

12 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment 177Lu-DTPA-SC16 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 mice, with high tumor targeting and minimal side effects. This suggests potential effectiveness in humans, although more research is needed. ^{1 2 3 4 5}

Is 177Lu-DTPA-SC16.56 safe for human use?

Research on 177Lu-DTPA-SC16, a similar treatment, showed it was generally safe in mice, with some temporary drops in blood cell counts and weight loss at high doses, but these effects quickly returned to normal. No serious side effects were reported in human studies of other 177Lu-labeled treatments, even in patients with existing kidney issues. ^{1 2 6 7 8}

What makes the treatment 177Lu-DTPA-SC16.56 unique for lung and prostate cancer?

177Lu-DTPA-SC16.56 is unique because it targets a specific protein called delta-like ligand 3 (DLL3) found on certain prostate cancer cells, making it a targeted radioimmunotherapy. This approach allows for precise delivery of radiation to cancer cells, potentially leading to better outcomes with fewer side effects compared to traditional treatments. ^{2 8 9 10 11}

What is the purpose of 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

Research Team

Lisa Bodei, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England 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). [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Delta-like ligand 3-targeted radioimmunotherapy for neuroendocrine prostate cancer. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Treatment of Advanced Metastatic Prostate Cancer Using Molecular-Targeted Therapy: Radioligand Lutetium-177 Prostate-Specific Membrane Antigen. [2023]

4. England 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. [2021]

5. England 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). [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

EANM dosimetry committee recommendations for dosimetry of 177Lu-labelled somatostatin-receptor- and PSMA-targeting ligands. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Toward Single-Time-Point Image-Based Dosimetry of 177Lu-PSMA-617 Therapy. [2023]

8. United Arab Emirates pubmed.ncbi.nlm.nih.gov

¹⁷⁷Lu-Labeled Agents for Neuroendocrine Tumor Therapy and Bone Pain Palliation in Uruguay. [2019]

9. Switzerland 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. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

161Tb-PSMA Unleashed: a Promising New Player in the Theranostics of Prostate Cancer. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Preclinical Characterization of the 177Lu-Labeled Prostate Stem Cell Antigen (PSCA)-Specific Monoclonal Antibody 7F5. [2023]