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New treatment option for Metastatic Castration-resistant Prostate Cancer, mCRPC
Official title 3D1015 Injection for Patients With mCRPC
ClinicalTrials.gov ID: NCT07537010
What this study is testing
What is Lu 177-PSMA-3D1015 Injection?
Lu 177-PSMA-3D1015 Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for 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 open-label clinical study investigates 3D1015 Injection (Lu 177-PSMA-3D1015) in adult males with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). Participants will receive intravenous infusions of 3D1015, with treatment regimens dynamically individualized to optimize patient safety and outcomes.
- 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 and older, men only
You may be able to join if
- Capable of understanding and providing written informed consent. Willing and able to comply with all study requirements, treatments, and scheduled...
- Male, aged 18 years or older.
- Histologically or cytologically confirmed prostate adenocarcinoma.
- Castrate levels of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L).
- Must be 68Ga-PSMA PET/CT scan positive.
You likely can't join if
- Receipt of other systemic anti-cancer therapies within 4 weeks prior to study entry.
- Life expectancy of \< 6 months, as assessed by the investigator.
- A superscan as seen in the baseline bone scan.
- Presence of clinically significant, uncontrolled, or unstable concurrent medical conditions that may compromise patient safety or study assessments.
- Known hypersensitivity or severe intolerance to the study drug, its excipients, or structurally related compounds.
- Any medical, psychiatric, or logistical condition that, per investigator judgment, would preclude protocol compliance or compromise patient safety.
See the full eligibility criteria
- Capable of understanding and providing written informed consent. Willing and able to comply with all study requirements, treatments, and scheduled visits.
- Male, aged 18 years or older.
- Histologically or cytologically confirmed prostate adenocarcinoma.
- Castrate levels of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L).
- Must be 68Ga-PSMA PET/CT scan positive.
- ECOG performance status of 0 to 2.
- Confirmed progressive metastatic castration-resistant prostate cancer (mCRPC) that is refractory to or has progressed following prior treatments.
- Presence of at least one metastatic lesion at baseline.
- Adequate Organ Function.
- Resolution of all prior treatment-related toxicities to Grade ≤ 2 (excluding alopecia).
- Receipt of other systemic anti-cancer therapies within 4 weeks prior to study entry.
- Life expectancy of \< 6 months, as assessed by the investigator.
- A superscan as seen in the baseline bone scan.
- Presence of clinically significant, uncontrolled, or unstable concurrent medical conditions that may compromise patient safety or study assessments.
- Known hypersensitivity or severe intolerance to the study drug, its excipients, or structurally related compounds.
- Any medical, psychiatric, or logistical condition that, per investigator judgment, would preclude protocol compliance or compromise patient safety.
The study team makes the final eligibility decision.
Where it's taking place
- Wuxi, Jiangsu, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuxi, Jiangsu, 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.