NCT07639086
Sacituzumab Tirumotecan in Pts w/ NEPC After Progression on Prior Chemotherapy
Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatmentVirginia Commonwealth UniversityInvestigator-initiated
~20 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:Sacituzumab Tirumotecan
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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)
Measured over Baseline, End of treatment, up to 30 months
Conditions
Where it's being run
1 sites across 1 statesVirginia1
Study leadership
- Asit Paul, MD · PRINCIPAL_INVESTIGATOR · Virginia Commonwealth University
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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. 6. 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. 7. The participant (or legally acceptable representative if applicable) provides written informed consent for the study. 8. 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. 9. 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. 10. 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. 11. Absolute neutrophil count ≥1500/µL 12. Platelets ≥100,000/µL 13. Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L 14. Creatinine clearance ≥30 mL/min 15. Total bilirubin ≤1.5 × ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 × ULN 16. ALT/AST ≤2.5 × ULN (≤5 × ULN for participants with liver metastases) 17. Albumin ≥3.0 g/dLb 18. 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.
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.
What this trial measures
- 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)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