Sacituzumab Tirumotecan in Pts w/ NEPC After Progression on Prior Chemotherapy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorVirginia Commonwealth University
About this trial
This is a phase 2, open-label, single-arm study of sacituzumab tirumotecan in neuroendocrine prostate cancer (NEPC) with progression after platinum-based chemotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Sacituzumab Tirumotecan
DrugSacituzumab 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
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Sacituzumab TirumotecanExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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)
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
Time frame
Baseline, End of treatment, up to 30 monthsSecondary outcomes
1
Evaluate progression free survival (PFS), in NEPC
The time from treatment to the first documented disease progression due to any cause, whichever occurs first
Time frame
Baseline, End of treatment, up to 30 months2
Evaluate overall survival (OS) in NEPC treated with sacituzumab tirumotecan
The time from treatment to death due to any cause
Time frame
Baseline, End of treatment, up to 30 months3
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
Time frame
Baseline, end of treatment, up to 30 months4
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
Time frame
Baseline, End of treatment, up to 30 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Virginia Commonwealth University
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov
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