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 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

. 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

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

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

Timeframe: Baseline through 30 days after end-of-treatment

Number of participants with deaths

Timeframe: Baseline through 30 days after end-of-treatment

Number of participants with treatment-emergent SAEs and AEs

Timeframe: Baseline through 30 days after end-of-treatment

Assessment of laboratory values.

Timeframe: Baseline through 30 days after end-of-treatment

Trial details

NCT IDNCT05544227

SponsorWilliams Cancer Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-10

View on ClinicalTrials.gov More Metastatic Castration-resistant Prostate Cancer trials

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

. 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

What they're measuring

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

Timeframe: Baseline through 30 days after end-of-treatment

Number of participants with deaths

Timeframe: Baseline through 30 days after end-of-treatment

Number of participants with treatment-emergent SAEs and AEs

Timeframe: Baseline through 30 days after end-of-treatment

Assessment of laboratory values.

Timeframe: Baseline through 30 days after end-of-treatment