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Anatomic Stage IV Breast Cancer AJCC v8Phase 1NCT06982222

Testing the Safety of the Anti-cancer Drug, Sn-117m-DTPA, for Advanced Cancers That Have Spread to Bones

A Phase 1 study testing Biospecimen Collection, Bone Scan and Computed Tomography in people with Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, run by National Cancer Institute (NCI).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This phase I trial tests the safety, side effects and best dose of tin (Sn)-177m-diethylenetriaminepentaacetic acid (DTPA) and how well it works in treating prostate, breast or non-small cell lung cancer that has spread from where it first started (primary site) to the bones (bone metastases). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Bone Scan and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Oct 2026to 12 Feb 2027
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically documented prostate, breast, or non-small cell lung cancer (NSCLC)
  • Metastatic disease in bone only (patients with visceral disease, cutaneous disease or malignant lymph nodes > 3 cm in largest diameter are not eligible)
  • Documented disease progression (1 or more new bone lesion or enlargement of existing bone lesion, identified by Tc-99m bone scintigraphy or CT scan, magnetic resonance imaging [MRI], fludeoxyglucose F-18 [FDG] PET CT scan or PSMA PET CT scan)
  • Must have progression on at least one line of standard of care systemic therapy. There are no maximum number of prior therapies
  • Patients with prostate cancer
  • Patients with prostate adenocarcinoma, their disease must be characterized as: must have prior bilateral orchiectomy or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L)
Show all 36Show fewer
  • Serum PSA progression, defined as two consecutive increases in PSA over a previous reference value, each measurement at least one week apart or, PSA progression ≥ 25% after 12 weeks of current standard of care (SOC) therapy (Scher et al., 2016)
  • Patients must have a baseline positive PSMA-PET scan. Patients must have progressed on at least one line of hormone therapy: Androgen receptor signaling inhibitors (ARSIs) therapy such as enzalutamide, apalutamide, darolutamide, or androgen synthesis blockers (abiraterone acetate). There are no minimum number of prior hormone therapies
  • Progression after chemotherapy (docetaxel or cabazitaxel) in patients who were chemotherapy candidates is allowed. However, prior chemotherapy is not required
  • Progression after a prostate-specific membrane antigen (PSMA)-targeted radiopharmaceutical therapy (for example: lutetium-177 vipivotide tetraxetan [Pluvicto]) is allowed but not required
  • Allowed to have received one prior cytotoxic chemotherapy treatment and one radiopharmaceutical therapy treatment OR no more than two cytotoxic chemotherapy treatments (for patients who have not received a prior radiopharmaceutical therapy treatment)
  • Patients with breast cancer
  • Patients with any estrogen receptor (ER)/progesterone receptor (PR)/human epidermal growth factor receptor 2 (HER2) receptor status are eligible
  • Patients with hormone-receptor positive disease should have progressed on at least one or more prior line(s) of SOC anti-estrogen therapy and a cyclin-dependent kinase (CDK)4/6 inhibitor (except if patient had a contraindication or intolerable toxicity with the use of these agents)
  • Patients with HER2 positive disease should have progressed on at least one or more line(s) of SOC anti-HER2 therapy.
  • Patients with triple negative disease should have progressed on at least one more line(s) of SOC chemotherapy
  • Previous radiation and chemotherapy are allowed
  • Patients with non-small cell lung cancer (NSCLC)
  • Patients with NSCLC should have progressed on at least one or more prior line(s) of SOC therapy, including chemotherapy and/or immunotherapy or targeted therapy if they qualify
  • Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of Sn-117m-DTPA in patients < 18 years of age, children are excluded from this study
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
  • Absolute neutrophil count ≥ 1,000/mcL
  • Platelets ≥ 75,000/mcL
  • Hemoglobin > 9 g/dL
  • Total bilirubin ≤ 2.5 x institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) ≤ 5 x institutional ULN
  • Creatinine ≤ 1.7 mg/dL OR glomerular filtration rate (GFR) ≥ 50 mL/min/1.73 m^2
  • Patients must be taking a bone health agent (bisphosphonates or denosumab) for at least one (1) month prior to enrollment
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better
  • The effects of Sn-117m-DTPA on the developing human fetus are unknown. For this reason and because radionucleotides are known to be teratogenic, male participants and their female partners of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. A woman of childbearing potential is a premenopausal female capable of becoming pregnant. Should a woman of childbearing potential become pregnant or suspect she is pregnant while her male partner is participating in this study, she should inform her treating physician immediately. Both men and women of childbearing potential treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 months after completion of Sn-117m-DTPA administration. For prostate cancer patients, androgen deprivation therapy is considered adequate contraception
  • Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign if the patient is physically (not mentally) not capable of signing

Who cannot join

  • Patients who have not recovered from reversible adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) with the exception of alopecia
  • Patients must not have received any investigational agents within 4 weeks or 5 half-lives, whichever is shorter, before starting study treatment, nor be scheduled to receive one during the planned treatment period
  • Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sn-117m-DTPA
  • Patients must not have imminent or established spinal cord compression, pathological fracture in weight bearing bones, or bone lesion with soft tissue component unless treated as appropriate with radiation and/or surgery before starting on this study
  • Patients must not have received prior systemic radiotherapy with strontium-89, samarium-153, rhenium-186, rhenium-188, or radium-223 dichloride (Xofigo) for the treatment of bony metastases. Prior systemic radiopharmaceutical therapy with lutetium Lu 177 vipivotide tetraxetan (Pluvicto) is permitted, but last treatment must be at least six weeks prior to starting study treatment due to the concern of bone marrow suppression
  • Patients must not have unmanageable urinary incontinence
  • Pregnant women are excluded from this study because Sn-117m-DTPA is a radionucleotide with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Sn-117m-DTPA, breastfeeding should be discontinued if the mother is treated with Sn-117m-DTPA

About this study

Official title: A First-in-Human Dose-Finding Phase I Study of Bone-targeted High Specific Activity Stannic-117m Pentatate (Sn-117m-DTPA) in Solid Tumors With Skeletal Metastases

This phase I trial tests the safety, side effects and best dose of tin (Sn)-177m-diethylenetriaminepentaacetic acid (DTPA) and how well it works in treating prostate, breast or non-small cell lung cancer that has spread from where it first started (primary site) to the bones (bone metastases). Sn-117m-DTPA was originally tested in tumors that had spread to the bones to help reduce bone pain. The drug has been improved and is designed to send low-level radiation to tumors in the bone while being gentler on the bone marrow, where blood cells are made. Sn-117m-DTPA may be safe and tolerable, and may slow down or shrink tumors in patients with metastatic prostate, breast, or non-small cell lung cancer that has spread to the bones.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess the safety and tolerability of tin Sn 117m pentetate (Sn-117m- diethylenetriaminepentaacetic acid [DTPA]) per Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

SECONDARY OBJECTIVES:

  1. To observe and record anti-tumor activity by prostate-specific membrane antigen (PSMA) positron emission tomography (PET) response criteria for prostate cancer and Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) response criteria for breast and non-small cell lung cancers.

II. To evaluate time to the first symptomatic skeletal event defined as (i) the first use of external-beam radiation therapy to relieve skeletal symptoms; (ii) new symptomatic pathologic vertebral or nonvertebral bone fractures; (iii) spinal cord compression; or (iv) tumor-related orthopedic surgical intervention (Scher et al., 2016).

III. To measure changes and time to progression in serum prostate-specific antigen (PSA) (in prostate cancer patients only), and bone-specific alkaline phosphatase (bALK PHOS) (in all patients).

IV. To evaluate 2-year progression-free survival (PFS) and overall survival (OS) rates.

  1. To characterize the biodistribution and dosimetry of high specific activity Sn-117m-DTPA in the treated population.

OUTLINE: This is a dose-escalation study followed by a dose-expansion study.

Patients receive Sn-117m-DTPA intravenously (IV) over 10 minutes on day 1 of each cycle. Cycles repeat every 56 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo urine and blood sample collection, PET/computed tomography (CT) and single photon emission computed tomography (SPECT)/CT throughout the study. Additionally, prostate cancer patients undergo technetium TC-99m (Tc-99m) bone scan at baseline and PSMA PET/CT throughout the study.

After completion of study treatment, patients are followed up every 6 months until death.

Being tested
Biospecimen Collection, Bone Scan, Computed Tomography, Positron Emission Tomography, PSMA PET Scan
Medical subject headings
Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo urine and blood sample collection

  • Bone ScanProcedure or surgery

    Also called Bone Scintigraphy

    Undergo technetium TC-99m bone scan

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo PET/CT, SPECT/CT and PSMA PET/CT

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

  • PSMA PET ScanProcedure or surgery

    Also called Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomography

    Undergo PSMA PET/CT

  • Single Photon Emission Computed TomographyProcedure or surgery

    Also called Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, Single-Photon Emission Computed, single-photon emission computed tomography

    Undergo SPECT/CT

  • Technetium TC-99mRadiation

    Also called Tc 99m, Technetium 99m

    Undergo technetium TC-99m bone scan

  • Tin Sn 117m PentetateRadiation

    Also called Pentetate Stannic SN-117M, Sn 117m Pentetic Acid, Sn-117m DTPA, Tin Sn 117m DTPA

    Given IV

Study groups in NCT06982222
Study groupRoleWhat they receive
Treatment (Sn-117m-DTPA)ExperimentalPatients receive Sn-117m-DTPA IV over 10 minutes on day 1 of each cycle. Cycles repeat every 56 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo urine and blood sample collection, PET/CT and SPECT/CT throughout the study. Additionally, prostate cancer patients undergo Tc-99m bone scan at baseline and PSMA PET/CT throughout the study.
Receives: Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Procedure: PSMA PET Scan; Procedure: Single Photon Emission Computed Tomography; Radiation: Technetium TC-99m; Radiation: Tin Sn 117m Pentetate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of dose-limiting toxicities

    Will be graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Will be summarized by severity grade, system organ class, and their relation to study treatment.

    Measured: Up to completion of 1 cycle (cycle length = 56 days)

  2. Frequency of adverse events

    Will be graded using NCI CTCAE v 5.0. Will be summarized by severity grade, system organ class, and their relation to study treatment.

    Measured: Up to 30 days after last dose of study treatment

Secondary outcomes (8)

  1. Tumor response

    Will be evaluated using prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) for prostate cancer and Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) for breast and non-small cell lung cancers. Categorical endpoints will be summarized by frequency and percent. Continuous variables will be summarized by mean and standard deviation at each assessment time point.

    Measured: Up to 2 years

  2. Time to first symptomatic skeletal event

    Will be defined as the first use of external-beam radiation therapy to relieve skeletal symptoms, new symptomatic pathologic vertebral or non-vertebral bone fractures, spinal cord compression or tumor-related orthopedic surgical intervention. Categorical endpoints will be summarized by frequency and percent. Continuous variables will be summarized by mean and standard deviation at each assessment time point. Will be analyzed using the Kaplan-Meier product limit method. Estimation and confidence intervals for the median time to first symptomatic skeletal event will be provided.

    Measured: Up to 2 years

  3. Changes in serum PSA (prostate cancer patients only)

    Categorical endpoints will be summarized by frequency and percent. Continuous variables will be summarized by mean and standard deviation at each assessment time point. Will be calculated for each of the above defined categories with the corresponding confidence intervals.

    Measured: At baseline, days 44-56 of cycle 1, and days 30-56 of cycle 2

  4. Time to progression in serum PSA (prostate cancer patients only)

    Categorical endpoints will be summarized by frequency and percent. Continuous variables will be summarized by mean and standard deviation at each assessment time point. Will be calculated for each of the above defined categories with the corresponding confidence intervals.

    Measured: At baseline, days 44-56 of cycle 1, and days 30-56 of cycle 2

  5. Changes in bone-specific alkaline phosphatase levels (all patients)

    Categorical endpoints will be summarized by frequency and percent. Continuous variables will be summarized by mean and standard deviation at each assessment time point. Will be calculated for each of the above defined categories with the corresponding confidence intervals.

    Measured: At baseline, days 44-56 of cycle 1, and days 30-56 of cycle 2

  6. Progression-free survival

    Categorical endpoints will be summarized by frequency and percent. Continuous variables will be summarized by mean and standard deviation at each assessment time point. Will be analyzed using the Kaplan-Meier product limit method.

    Measured: From the first study treatment until the date of PERCIST definition of progression for breast and non-small cell lung cancers and PSMA PET/CT definition of progression for prostate cancer, assessed up to 2 years

  7. Overall survival

    Categorical endpoints will be summarized by frequency and percent. Continuous variables will be summarized by mean and standard deviation at each assessment time point. Will be analyzed using the Kaplan-Meier product limit method.

    Measured: From the first study treatment until the date of death, assessed up to 2 years

  8. Biodistribution and dosimetry of high specific activity tin (Sn)-117m-diethylenetriaminepentaacetic acid (DTPA)

    Categorical endpoints will be summarized by frequency and percent. Continuous variables will be summarized by mean and standard deviation at each assessment time point. All results are expressed as mean percent of injected dose +/- standard deviation; the mean values will be tested by Student t test for statistical significance. Regions of interest will be drawn over normal bone and metastatic foci, and decay-corrected counts of pixels drawn from all Sn-117m-DTPA scans. Counts per pixels will be plotted against time. Time to peak was noted for both normal and metastatic bone lesions. The slope of the curve will be assessed for evidence of washout.

    Measured: On days 1, 2, 4, and 43 of cycle 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2025
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion12 Feb 2027 (estimated)
  4. Study completion12 Feb 2027 (estimated)

Why it stopped: Other - Protocol moved to Withdrawn

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06982222
Sponsor's protocol ID
NCI-2025-03588
Other IDs
NCI-2025-03588, 10666, 10666, UM1CA186712
Status last verified
Aug 2026
First submitted
20 May 2025
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Biospecimen Collection, Bone Scan and Computed Tomography in people with Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, run by National Cancer Institute (NCI).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 36 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of dose-limiting toxicities (time frame: Up to completion of 1 cycle (cycle length = 56 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06982222.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.

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