BridgeMD
New treatment option for PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC)
Official title Clinical Evaluation of 177Lu-PSMA-VG01 Injection in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer （mCRPC）
ClinicalTrials.gov ID: NCT07660211
What this study is testing
What is 177Lu-PSMA-VG01?
177Lu-PSMA-VG01 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for psma-positive metastatic castration-resistant prostate cancer (mcrpc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase I clinical trial conducted in participants with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). After confirmation of PSMA positivity, participants receive intravenous administration of 177Lu-PSMA-VG01.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80, men only
You may be able to join if
- Male participants aged 18 years (inclusive) to 80 years (exclusive) at the time of signing the informed consent.
- Histologically or cytologically confirmed prostate cancer with no standard treatment options available, or failure/intolerance to standard therapies...
- During the screening period, imaging examinations (within 4 weeks before administration) showed the presence of ≥1 metastatic lesion.
- ECOG Performance Status score: 0 to 2.
- Expected survival time exceeds 6 months.
You likely can't join if
- Having received anti-tumor therapies such as chemotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks prior to the first...
- Having received systemic or local radionuclide therapy within 3 months prior to the first dose.
- Having received other investigational product treatments not yet approved within 4 weeks prior to the first dose of the investigational product, or...
- Having undergone major organ surgery (excluding needle biopsy) or experienced significant trauma within 4 weeks prior to the first dose of the...
- Having been diagnosed with other malignancies within the past 2 years (participants with a prior history of malignancy who have received adequate...
- Having symptomatic spinal cord compression or clinical/imaging findings suggestive of impending spinal cord compression.
See the full eligibility criteria
- Male participants aged 18 years (inclusive) to 80 years (exclusive) at the time of signing the informed consent.
- Histologically or cytologically confirmed prostate cancer with no standard treatment options available, or failure/intolerance to standard therapies, or inability to access standard treatment.
- During the screening period, imaging examinations (within 4 weeks before administration) showed the presence of ≥1 metastatic lesion.
- ECOG Performance Status score: 0 to 2.
- Expected survival time exceeds 6 months.
- All clinically significant toxicities related to prior anti-tumor therapy (e.g., chemotherapy, radiotherapy, etc., excluding Luteinizing Hormone-Releasing Hormone (LHRH) analog therapy) must have resolved to ≤ Grade 1...
- The participant must be fully informed about the study and voluntarily provide written informed consent prior to participation.
- The participant must be capable of understanding and complying with the requirements of the trial protocol.
- The participant must use a condom during sexual activity throughout the study period and for 14 weeks after the last dose of study treatment to prevent pregnancy in partners and potential exposure of partners to the...
- Having received anti-tumor therapies such as chemotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks prior to the first dose of the investigational product, or planning to receive such...
- Having received systemic or local radionuclide therapy within 3 months prior to the first dose.
- Having received other investigational product treatments not yet approved within 4 weeks prior to the first dose of the investigational product, or within five half-lives of that.
- Having undergone major organ surgery (excluding needle biopsy) or experienced significant trauma within 4 weeks prior to the first dose of the investigational product, or requiring elective surgery during the trial...
- Having been diagnosed with other malignancies within the past 2 years (participants with a prior history of malignancy who have received adequate treatment and have remained disease- and treatment-free for over 3 years...
- Having symptomatic spinal cord compression or clinical/imaging findings suggestive of impending spinal cord compression.
- Known allergy to structural analogs of this product or other excipients.
- Having a history of immunodeficiency, including a positive HIV test result, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; a history of severe autoimmune diseases deemed...
- Having severe infections (requiring intravenous antibiotics, antifungals, or antivirals according to clinical practice guidelines), active hepatitis A, active hepatitis B (HBV DNA ≥2000 IU/mL or 10\^4 copies/mL...
- Having uncontrolled third-space fluid accumulations (such as significant pleural effusion, ascites or pericardial effusion) deemed unsuitable for enrollment by the investigator.
- Having a clear history of neurological or psychiatric disorders, including epilepsy or dementia.
- Other reasons considered by the investigator to make the participant unsuitable for participation in this clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.