None listed
Conditions
Brief summary
This is a study to investigate whether Sacituzumab tirumotecan (an antibody-drug conjugate) will be an effective treatment for metastatic castration resistant prostate cancer participants. Who is it for? This study is for participants who have histologically confirmed adenocarcinoma of the prostate and who have progressed after being treated with Androgen Deprivation Therapy. Study Details: There is only one treatment available as part of this study, All participants who choose to enrol will be offered the same treatment. Sacituzumab tirumotecan will be given to participants via an infusion into a vein, once every 2 weeks. Participants will need to attend the treating hospital to receive this treatment. They will also undergo additional assessments like blood test, urine test, vital signs and CT/PSMA PET scans. Participants will be asked to undergo a PSMA PET/CT imaging at the time that they enrol in the study, then at 8 weeks, 16 weeks, 26 weeks and then at 12-weekly increments. Participants will also be asked to complete a quality-of-life questionnaire throughout the study. It is hoped the result of this study will be used to inform and design randomised phase III trials of sacituzumab tiromotecan.
Interventions
STATEsMAN will seek to describe clinical efficacy outcomes in patients with metastatic castrate resistant prostate cancer (mCRPC) who are treated with sacituzumab tirumotecan (sac-TMT,
STATEsMAN is designed to collect clinical, molecular, radiographic, quality of life and translational data that will be utilised to characterise the multiplicity of effects that sacituzumab tiromtecan can have on mCRPC patients.
200mg of Sacituzumab tiromtecan will be given by an intravenous infusion every 2 wee
STATEsMAN will seek to describe clinical efficacy outcomes in patients with metastatic castrate resistant prostate cancer (mCRPC) who are treated with sacituzumab tirumotecan (sac-TMT, STATEsMAN is designed to collect clinical, molecular, radiographic, quality of life and translational data that will be utilised to characterise the multiplicity of effects that sacituzumab tiromtecan can have on mCRPC patients. 200mg of Sacituzumab tiromtecan will be given by an intravenous infusion every 2 week for a maximun of 3 years, or until either disease progression, unacceptable toxicity or withdrawal of consent. This infusion will be given by qualified oncology nurses in the oncology daycare unit. Local laboratory bloods and urine test will be taken prior to every infusion to ensure the patient is safe to receive the treatment.
Sponsors
Metro South Hospital and Health Services
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria 1. Have histologically confirmed adenocarcinoma of the prostate without small cell histology. The diagnosis must be stated in a pathology report and confirmed by the investigator. 2. Have prostate cancer progression while receiving and Androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before screening. Prostate cancer progression will be determined by the investigator, defined as 1 of the following: - Prostate-specific antigen (PSA) progression shown by local laboratory values, as defined by a minimum of 2 consecutive rising PSA levels with an interval of greater than or equal to 1 week between each assessment, where PSA at screening should be greater than or equal to 1 ng/mL. - Radiographic disease progression in soft tissue based on RECIST 1.1, with or without PSA progression. - Radiographic disease progression in bone per Prostate Cancer Working Group (PCWG), defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression. 3. Have disease progression under the following conditions if the participant received first generation anti-androgen therapy before screening: - Evidence of progression greater than 4 weeks since the last flutamide treatment. - Evidence of progression greater than 6 weeks since the last bicalutamide or nilutamide treatment. 4. Have current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease shown by Computerised tomography scan (CT)/Magnetic Resonance Imaging (MRI). 5. Have disease that progressed during or after treatment with 1 Androgen receptor paythway inhibitor (ARPI) (eg, abiraterone acetate, enzalutamide, apalutamide, darolutamide) for Non-metastatic hormone-sensitive prostate cancer (nmHSPC), Non metastatic castration-sensitive prostate cancer (nmCRPC), Metastatic hormone-sensitive prostate cancer (mHSPC), or Metastatic castration resistant prostate cancer (mCRPC) for at least 8 weeks (at least 14 weeks for participants with bone progression). - Participants that received ARPI for nmHSPC, nmCRPC, mHSPC, mCRPC may not have received another ARPI treatment before enrolment. - Note: Participants may have received abiraterone acetate and docetaxel or darolutamide and docetaxel for mHSPC. However, participants must have received no more than 6 cycles of docetaxel and had no radiographic disease progression while receiving docetaxel. 6. May receive only 1 taxane treatment and have had Progressive Disease (PD) during or after treatment. If docetaxel chemotherapy has been used more than once (eg, once for mHSPC and once for mCRPC), it will be considered as 1 taxane-based chemotherapy, provided that the mHSPC setting the patient did not have radiographic progression of disease within 1 year. Prior docetaxel is allowed if greater than or equal to 4 weeks have elapsed from the last dose of most recent taxane-based chemotherapy before the date of Cycle1 Day 1. 7. Prior treatment with pharmacological inhibitors of the enzyme polyADP ribose polymerase (PARP) inhibitor is allowed if indicated as per local guidelines, unless the patient was deemed ineligible to receive PARP inhibitor by the investigator or the patient refused PARP inhibitor. 8. Prior treatment with up to one line of Prostate specific membrane antigen (PSMA) -based radionuclides is allowed. 9. Have ongoing androgen deprivation with serum testosterone less than 50 ng/d. If the participant is currently being treated with Luteinizing hormone-releasing hormone (LHRH) agonists or antagonists (in participants who have not undergone orchiectomy), this therapy must have been initiated at least 4 weeks before the date of Cycle1 Day 1, and treatment must be continued throughout the study. 10. Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for greater than or equal to 4 weeks before the date of C1D1. 11. Is an individual of any sex/gender and is at least 18 years of age at the time of providing the informed consent 12. If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate the study intervention after the last dose of study intervention. The length of time required to continue contraception for sacituzumab tirumotecan is 120 days. • 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 as a condom may break or leak OR • Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed. 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 14. Has provided an archival tumor tissue sample or most recently obtained core, incisional, or excisional biopsy of a tumor lesion from any site not previously irradiated. Sites should follow local guidelines regarding fresh tissue collection. 15. Participants who have AEs due to previous anticancer therapies must have recovered to Grade less than or equal to 1 or baseline (except for alopecia and vitiligo). Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible. 16. HIV-infected participants must have well controlled HIV on Antiretroviral therapy (ART), defined as: a. Participants on ART must have a CD4+ T-cell count greater than or equal to 350 cells/mm3 at the time of screening b. Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the lower limit of quantification (LLOQ)(below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening c. It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months d. Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study 17. Adequate organ function 18. An ECOG performance status of 0 to 1 assessed within 7 days before C1D1. 19. 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 C1D1. 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 screening tests are not required unless: Known history of HBV infection Mandated by local health authority 20. Participants with history of HCV infection are eligible if HCV viral load is undetectable at Screening. Hepatitis C screening tests are not required unless: Known history of HCV infection Mandated by local health authority
Exclusion criteria
Exclusion Criteria An individual must be excluded from the study if the individual meets any of the following criteria: Medical Conditions 1. 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. 2. 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 greater than 480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months before the first dose of study intervention. 3. History or family history of long QTc syndrome. 4. Has a resting ECG indicating uncontrolled, potentially reversible cardiac conditions as judged by the investigator (eg, unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation >480 msec, electrolyte disturbances, etc) or has congenital long QT syndrome. 5. Has greater than grade 2 peripheral neuropathy. 6. Has a history of clinically significant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, torsades de pointes) or has a history of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place. Prior/Concomitant Therapy 7. Received prior treatment with a TROP2-targeted ADC. 8. Received prior treatment with a topoisomerase 1 inhibitor-containing ADC. 9. Received prior systemic anticancer therapy within 2 weeks before the first dose of study intervention. 10. 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. 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. 11. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed. 12. 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. 13. Is currently enrolled on another therapeutic clinical trial. Concurrent enrollment on another therapeutic clinical trial or any trial designed to impact the efficacy of anti-cancer therapy is prohibited. 14. Has received an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention. Diagnostic Assessments 15. 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. 16. 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. 17. Has an active infection requiring systemic therapy, on antibiotics within 5 days of C1D1 18. 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. Other Exclusions 19. Severe hypersensitivity (Grades greater than or equal to 3) to study intervention, any of their excipients, and/or to another biologic therapy. 20. 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. 21. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Outcome results
None listed