Phase 1 Trial of SYNC-T - Immunotherapy for Advanced/Metastatic Castration-Resistant Prostate Cancer (NCT05544227) | Clinical Trial Compass
CompletedPhase 1
Phase 1 Trial of SYNC-T - Immunotherapy for Advanced/Metastatic Castration-Resistant Prostate Cancer
Mexico15 participantsStarted 2023-02-01
Plain-language summary
SV-102 is intended to overcome the complex and multifactorial nature of the mechanisms mediating tumor immune evasion, by the use of a combination of therapeutic agents that elicit multiple immuno-pharmacologic effects.
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male \>18 years old at the time of signed informed consent
✓. Provide written informed consent
✓. Subjects with advanced and/or metastatic histologically or cytologically confirmed castrate-resistant prostate cancer
✓. After failure after the receipt of previous treatment with one or more approved second-generation androgen-receptor-pathway inhibitors and with or without a prior course of taxanes therapy or those with metastatic prostate cancer who have refused hormone therapy and chemotherapy, or have not responded or progressed after standard therapies or for whom no further standard therapy exists or standard therapy is not available
✓. Patients who may or may not have had prior therapy with Lutetium Lu-177-PSMA-I\&T
✓. Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) v5 grade ≤ 1.
✓. Measurable disease by RECIST.
✓. Meet all eligibility criteria
Exclusion criteria
✕. Has a known other primary malignancy other than prostate cancer that is progressing or has required active treatment in the last 3 years, excluding basal and squamous cell carcinoma, papillary thyroid cancer, and ductal carcinoma in situ of the breast
✕. Has an obstructed urinary system before or after stenting
What they're measuring
1
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Timeframe: Baseline through 30 days after end-of-treatment
2
Number of participants with deaths
Timeframe: Baseline through 30 days after end-of-treatment
3
Number of participants with treatment-emergent SAEs and AEs
Timeframe: Baseline through 30 days after end-of-treatment
4
Assessment of laboratory values.
Timeframe: Baseline through 30 days after end-of-treatment
. Has undergone major surgery, including local prostate intervention (excluding prostate biopsy), within 28 days prior to the first dose of study drug and has not recovered adequately from the toxicities and/or complications
✕. Has an active infection (including tuberculosis) requiring systemic therapy
✕. Has a history of non-infectious pneumonitis that required steroids
✕. Has received a live vaccine within 30 days prior to the enrollment Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 28 days prior to the first treatment
✕. Significant cardiac or other medical illness such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia (e.g. New York Heart Association Class 4), or history of previous heart failure
✕. Malignant pleural effusions or ascites that require immediate intervention