Sacituzumab Tirumotecan in Pts w/ NEPC After Progression on Prior Chemotherapy (NCT07639086) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Sacituzumab Tirumotecan in Pts w/ NEPC After Progression on Prior Chemotherapy
United States20 participantsStarted 2026-08-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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.
. Male participant at least 18 years of age at the time of providing the informed consent.
. If capable of producing sperm, the participant agrees to the following during the intervention period and for at least 120 days after:
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
Timeframe: Baseline, End of treatment, up to 30 months
. 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.
Exclusion criteria
. 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.
. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
. 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.