Prostate CancerPhase 2STOP-NEPCNCT07639086
Sacituzumab Tirumotecan in Pts w/ NEPC After Progression on Prior Chemotherapy
A Phase 2 study testing Sacituzumab Tirumotecan in people with Prostate Cancer and Neuroendocrine Prostate Cancer (NEPC), run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This is a phase 2, open-label, single-arm study of sacituzumab tirumotecan in neuroendocrine prostate cancer (NEPC) with progression after platinum-based chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Neuroendocrine Prostate Cancer (NEPC)
- What is being tested?
- Sacituzumab Tirumotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2026to 31 Mar 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically or cytologically confirmed diagnosis of de novo (d-NEPC) or treatment related NEPC (t-NEPC), defined by one or more of the following: histologically small cell prostate cancer or neuroendocrine differentiation by IHC, defined by positive staining by chromogranin or synaptophysin and/or additional neuroendocrine markers. Patients with t-NEPC must have history of treatment with ADT and/or an androgen receptor pathway inhibitor (ARPI) agent.
- Note: Pure small cell/NEPC or NEPC mixed with adenocarcinoma or other histologic subtype are eligible
- Patients must have progressed following at least one course (minimum of 4 cycles) of platinum-based chemotherapy (alone or in combination with etoposide or taxane). Patients who received prior taxane alone for treatment of mHSPC or mCRPC, and patients who received a checkpoint inhibitor immunotherapy alone or in combination with prior chemotherapy are eligible. Patients who received a non-ADC drug through a prior clinical trial or Tarlatamab are also eligible provided they had also received at least one course of platinum-based chemotherapy.
- Patients who have measurable metastatic disease per PCWG modified RECIST 1.1 criteria as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions. Patients with radiologically positive pelvic nodal, bone or soft tissue metastatic disease, are acceptable. Progressive disease is defined per PCWG modified RECIST 1.1 criteria.
- Note: Patients who have prior prostatectomy, definitive or salvage radiation, are eligible.
- Male participant at least 18 years of age at the time of providing the informed consent.
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- If capable of producing sperm, the participant agrees to the following during the intervention period and for at least 120 days after:
- Refrains from donating sperm
- Uses a penile/external condom when having penile-vaginal intercourse with a nonparticipant of childbearing potential who is not currently pregnant PLUS partner use of an additional contraceptive method (refer to Section 10.4.2), as a condom may break or leak Note: If the participant is azoospermic (vasectomized or secondary to medical cause, documented from the site personnel's review of the participant's medical records, medical examination, or medical history interview), no contraception is required.
- If capable of producing ejaculate whose partner is pregnant or breastfeeding must agree to use a penile/external condom during each episode of sexual activity in which the partner is at risk of drug exposure via ejaculate.
- The participant (or legally acceptable representative if applicable) provides written informed consent for the study.
- Has provided an archival tumor tissue sample collected within 12 months prior to the enrollment or most recently obtained core, incisional, or excisional biopsy of a tumor lesion from prostate or a metastatic site, from which NEPC was diagnosed. Irradiated tissue is not acceptable. Sites should follow local guidelines regarding fresh tissue collection.
- Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (except for alopecia and vitiligo). Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible.
- Adequate organ function as defined below. Specimens must be collected within 10 days before the start of study intervention. Any value of serum prostate specific antigen (PSA) is considered eligible.
- Absolute neutrophil count ≥1500/µL
- Platelets ≥100,000/µL
- Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L
- Creatinine clearance ≥30 mL/min
- Total bilirubin ≤1.5 × ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN
- ALT/AST ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)
- Albumin ≥3.0 g/dLb
- INR or PT/aPTT ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants a Criteria must be met without colony-stimulating factors, erythropoietin dependency, and without pRBC transfusion within the preceding 2 weeks.
- b Criteria must be met without albumin supplementation within the last 72 hours.
- Has ECOG performance status of 0 or1
- Be willing and able to comply with study procedures, laboratory tests, and other requirements of the study.
- HIV-infected participants must have well-controlled HIV on ART, defined as:
- Having a CD4+ T-cell count ≥350 cells/mm3 at the time of screening
- Having achieved and maintained virologic suppression, defined as confirmed HIV RNA level below 50 or the LLOQ using the locally available assay, at the time of screening and for at least 12 weeks before screening
- Absence of any AIDS-defining opportunistic infections within the past 12 months
- Being on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before enrollment and agreeing to continue ART throughout the study Note: The ART regimen must not contain any antiretroviral medications that are strong CYP3A4 inducers/inhibitors/substrates. Refer to https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers. Please note that this list is not exhaustive and that investigators should review the locally approved label for all concomitant therapy to ensure it is not a strong inducer/inhibitor/substrate of CYP3A4.
- Note: HIV testing at screening is not required unless there is a known history of HIV infection or it is mandated by local guidelines
- Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load before enrollment.
- Note: Participants should remain on antiviral therapy throughout study intervention and follow local guidelines for HBV antiviral therapy post completion of study intervention.
- Hepatitis B testing at screening is not required unless there is a known history of HBV infection or it is mandated by local guidelines
- Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening.
- Note: Participants must have completed curative antiviral therapy at least 4 weeks before enrollment. Hepatitis C testing at screening is not required unless there is a known history of HCV infection or it is mandated by local guidelines
Who cannot join
- Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months before the first dose of study intervention.
- Received prior treatment with a TROP2-targeted ADC.
- Received prior treatment with a topoisomerase 1 inhibitor-containing ADC.
- Received prior systemic anticancer therapy within 2 weeks before the first dose of study intervention. ADT and/or antiandrogens/ARPI is allowed.
- Received prior radiotherapy within 2 weeks before the first dose of study intervention, has radiation-related toxicities, requiring corticosteroids, and/or has had radiation pneumonitis.
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- Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
- Refer to Section 6.2 for information on COVID-19 vaccines.
- Is currently receiving a strong inducer/inhibitor of CYP3A4 that cannot be discontinued for the duration of treatment with study intervention. The required washout period before starting study intervention is 2 weeks.
- Note: A list of strong inducers/inhibitors of CYP3A4 can be found at the following website: https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers. Please note that this list is not exhaustive and that investigators should review the locally approved label for all concomitant therapy to ensure it is not a strong inducer/inhibitor of CYP3A4.
- Is currently enrolled on another therapeutic clinical trial. Concurrent enrollment on another therapeutic clinical trial or any trial designed to impact the efficacy of anticancer therapy is prohibited.
- Has received an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding carcinoma in situ of the bladder) who have undergone potentially curative resection are not excluded.
- Note: Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and PSA <10 ng/mL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.
- Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously-treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable, and have not required steroid treatment for at least 14 days before the first dose of study intervention.
- Has an active infection requiring systemic therapy (except those permitted per Section 5.1)
- Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, interfere with the individual's ability to cooperate with the requirements of the study, or interfere with the individual's participation for the full duration of the study, such that it is not in the best interest of the individual to participate, in the opinion of the treating investigator.
- Severe hypersensitivity (Grades ≥3) to study intervention, any of their excipients, and/or to another biologic therapy.
- Has had major surgery or significant traumatic injury within 4 weeks before the first dose of study intervention. Anticipation of the need for major surgery during the course of treatment with study intervention is also exclusionary.
- Note: Participants who underwent major surgery must have adequately recovered from toxicity and/or complications from the surgery before starting study intervention.
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the study enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc), any autoimmune, connective tissue, or inflammatory disorders with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc), prior pneumonectomy, or requirement for supplemental oxygen.
- Has a "superscan" bone scan. This is defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
Massey CTO GU Team, 804-628-6430, masseygu@vcu.edu
Asit Paul, MD
About this study
Official title: Sacituzumab Tirumotecan in Patients With Neuroendocrine Prostate Cancer After Progression on Prior Chemotherapy
This is a phase 2, open-label, single-arm study of sacituzumab tirumotecan in neuroendocrine prostate cancer (NEPC) with progression after platinum-based chemotherapy.
Read the detailed description
Neuroendocrine prostate cancer (NEPC) is an aggressive variant of prostate cancer with poor outcome and limited therapeutic options. Sacituzumab tirumotecan (sac-TMT) is an antibody-drug conjugate (ADC) directed against TROP2. The purpose of this study is to investigate the efficacy and safety of Sacituzumab Tirumotecan in patients with de novo or treatment related NEPC who progress after treatment with platinum-based chemotherapy.
- Being tested
- Sacituzumab Tirumotecan
- Keywords
- Neuroendocrine Prostate Cancer, Progression, NEPC, Small Cell Prostate Cancer, Treatment-Emergent NEC Prostate Cancer, Sacituzumab Tirumotecan, TROP2, Platinum-Refractory Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab TirumotecanDrug
Sacituzumab tirumotecan will be administered by intravenous (IV) infusion on Days 1, 15, and 29 of each 42-day cycle until disease progression or criteria of disease progression met
| Study group | Role | What they receive |
|---|---|---|
| Sacituzumab Tirumotecan | Experimental | Sacituzumab tirumotecan 4mg/kg Intravenous infusion Receives: Drug: Sacituzumab Tirumotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the objective response rate (ORR) of sacituzumab tirumotecan in NEPC per Prostate Cancer Working Group (PCWG) modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
The percentage of patients with confirmed partial response (PR) or complete response (CR) based on RECIST 1.1 criteria where Complete Response (CR) - disappearance of all target lesions and measurable lymph nodes.
Partial Response (PR) - ≥30% decrease in the sum of target lesion diameters (SLD) compared to baseline, with no new lesions or progression of non-target lesions.
Stable Disease (SD) - change in SLD between -30% and +20% compared to baseline, with no new or unequivocally progressing non-target lesions.
Progressive Disease (PD) - ≥20% increase in SLD compared to the smallest recorded SLD (nadir) or appearance of new lesion
Measured: Baseline, End of treatment, up to 30 months
Secondary outcomes (5)
Evaluate progression free survival (PFS), in NEPC
The time from treatment to the first documented disease progression due to any cause, whichever occurs first
Measured: Baseline, End of treatment, up to 30 months
Evaluate overall survival (OS) in NEPC treated with sacituzumab tirumotecan
The time from treatment to death due to any cause
Measured: Baseline, End of treatment, up to 30 months
Evaluate time to response (TTR) in NEPC treated with sacituzumab tirumotecan
For participants with a confirmed response; complete response (CR) or partial response (PR), the time it takes to show a measurable response from receiving the 1st dose of study drug
Measured: Baseline, end of treatment, up to 30 months
Evaluate duration of response (DOR) in NEPC treated with sacituzumab tirumotecan
For participants with a confirmed response, the time from first documented evidence of complete response (CR) or partial response (PR) to either disease progression or death due to any cause, whichever occurs first
Measured: Baseline, End of treatment, up to 30 months
Evaluate safety and tolerability Incidence and severity of adverse events defined by The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 6 (CTCAE v6).
The Incidence and severity of adverse events defined by CTCAE v6
Measured: Baseline, 30 days following end of treatment, up to 30 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start31 Aug 2026 (estimated)
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Asit Paul, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639086
- Sponsor's protocol ID
- MCC-24-21994
- Acronym
- STOP-NEPC
- Status last verified
- Aug 2026
- First submitted
- 5 Jun 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share data at this time.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacituzumab Tirumotecan in Patients With Neuroendocrine Prostate Cancer After Progression on Prior Chemotherapy
- ClinicalTrials.gov ID
- NCT07639086
- Acronym / sponsor ID
- STOP-NEPC / MCC-24-21994
- Keywords
- Neuroendocrine Prostate Cancer, Progression, NEPC, Small Cell Prostate Cancer, Treatment-Emergent NEC Prostate Cancer, Sacituzumab Tirumotecan, TROP2, Platinum-Refractory Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Mar 2032 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2, open-label, single-arm study of sacituzumab tirumotecan in neuroendocrine prostate cancer (NEPC) with progression after platinum-based chemotherapy.
Detailed description
Neuroendocrine prostate cancer (NEPC) is an aggressive variant of prostate cancer with poor outcome and limited therapeutic options. Sacituzumab tirumotecan (sac-TMT) is an antibody-drug conjugate (ADC) directed against TROP2. The purpose of this study is to investigate the efficacy and safety of Sacituzumab Tirumotecan in patients with de novo or treatment related NEPC who progress after treatment with platinum-based chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sacituzumab Tirumotecan | Experimental | Drug: Sacituzumab TirumotecanSacituzumab tirumotecan 4mg/kg Intravenous infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (36 listed)
- Patients with histologically or cytologically confirmed diagnosis of de novo (d-NEPC) or treatment related NEPC (t-NEPC), defined by one or more of the following: histologically small cell prostate cancer or neuroendocrine differentiation by IHC, defined by positive staining by chromogranin or synaptophysin and/or additional neuroendocrine markers. Patients with t-NEPC must have history of treatment with ADT and/or an androgen receptor pathway inhibitor (ARPI) agent.
- Note: Pure small cell/NEPC or NEPC mixed with adenocarcinoma or other histologic subtype are eligible
- Patients must have progressed following at least one course (minimum of 4 cycles) of platinum-based chemotherapy (alone or in combination with etoposide or taxane). Patients who received prior taxane alone for treatment of mHSPC or mCRPC, and patients who received a checkpoint inhibitor immunotherapy alone or in combination with prior chemotherapy are eligible. Patients who received a non-ADC drug through a prior clinical trial or Tarlatamab are also eligible provided they had also received at least one course of platinum-based chemotherapy.
- Patients who have measurable metastatic disease per PCWG modified RECIST 1.1 criteria as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions. Patients with radiologically positive pelvic nodal, bone or soft tissue metastatic disease, are acceptable. Progressive disease is defined per PCWG modified RECIST 1.1 criteria.
- Note: Patients who have prior prostatectomy, definitive or salvage radiation, are eligible.
Key exclusion criteria (25 listed)
- Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months before the first dose of study intervention.
- Received prior treatment with a TROP2-targeted ADC.
- Received prior treatment with a topoisomerase 1 inhibitor-containing ADC.
- Received prior systemic anticancer therapy within 2 weeks before the first dose of study intervention. ADT and/or antiandrogens/ARPI is allowed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacituzumab TirumotecanSacituzumab tirumotecan will be administered by intravenous (IV) infusion on Days 1, 15, and 29 of each 42-day cycle until disease progression or criteria of disease progression met | Drug | Sacituzumab Tirumotecan |
Primary outcome
Evaluate the objective response rate (ORR) of sacituzumab tirumotecan in NEPC per Prostate Cancer Working Group (PCWG) modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Time frame: Baseline, End of treatment, up to 30 months
The percentage of patients with confirmed partial response (PR) or complete response (CR) based on RECIST 1.1 criteria where Complete Response (CR) - disappearance of all target lesions and measurable lymph nodes. Partial Response (PR) - ≥30% decrease in the sum of target lesion diameters (SLD) compared to baseline, with no new lesions or progression of non-target lesions. Stable Disease (SD) - change in SLD between -30% and +20% compared to baseline, with no new or unequivocally progressing non-target lesions. Progressive Disease (PD) - ≥20% increase in SLD compared to the smallest recorded SLD (nadir) or appearance of new lesion
5 secondary outcomes
Evaluate progression free survival (PFS), in NEPC
Time frame: Baseline, End of treatment, up to 30 months
Evaluate overall survival (OS) in NEPC treated with sacituzumab tirumotecan
Time frame: Baseline, End of treatment, up to 30 months
Evaluate time to response (TTR) in NEPC treated with sacituzumab tirumotecan
Time frame: Baseline, end of treatment, up to 30 months
Evaluate duration of response (DOR) in NEPC treated with sacituzumab tirumotecan
Time frame: Baseline, End of treatment, up to 30 months
Evaluate safety and tolerability Incidence and severity of adverse events defined by The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 6 (CTCAE v6).
Time frame: Baseline, 30 days following end of treatment, up to 30 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- VCU Massey Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. There are no plans to share data at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Asit Paul, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sacituzumab Tirumotecan in people with Prostate Cancer and Neuroendocrine Prostate Cancer (NEPC), run by Virginia Commonwealth University at 1 site in United States.
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 25 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: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Massey IIT Research Operations (804-628-6430, masseyepd@vcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the objective response rate (ORR) of sacituzumab tirumotecan in NEPC per Prostate Cancer Working Group (PCWG) modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) (time frame: Baseline, End of treatment, up to 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2026.