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A Phase II, randomized, open-label, multi-center study of JSB462 (luxdegalutamide) in combination with lutetium (177Lu) vipivotide tetraxetan in adult male patients with PSMA-positive metastatic castration resistant prostate cancer (mCRPC)
EU CTIS ID: 2024-520155-24-00
What this study is testing
- To determine JSB462 dose for phase III (100 mg or 300 mg QD) in combination with AAA617 based on efficacy, safety and tolerability - To compare JSB462 pooled doses or best of the two doses 100 mg /300 mg QD in combination with AAA617 versus AAA617 alone in terms of efficacy, safety and tolerability
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult male participants with histologically and/or cytologically confirmed adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible.
- An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade ≤2.
- At least 1 bone or visceral metastatic lesion present on baseline CT, MRI, or bone scan imaging obtained ≤28 days prior to initiation of study treatment.
- Participants must be gallium (68Ga) gozetotide PET/CT scan positive and eligible as determined by the sponsor’s central reader.
- Participant must have prior exposure to at least one second generation ARPI in the metastatic/advanced setting.
- Previous treatment with a maximum of 2 taxane regimens is allowed.
You likely can't join if
- Prior treatment with any RLT (approved or investigational) is not allowed
- Prior treatment with a protein degrader compound that targets AR is not allowed
See the full eligibility criteria
- Adult male participants with histologically and/or cytologically confirmed adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible.
- An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade ≤2.
- At least 1 bone or visceral metastatic lesion present on baseline CT, MRI, or bone scan imaging obtained ≤28 days prior to initiation of study treatment.
- Participants must be gallium (68Ga) gozetotide PET/CT scan positive and eligible as determined by the sponsor’s central reader.
- Participant must have prior exposure to at least one second generation ARPI in the metastatic/advanced setting.
- Previous treatment with a maximum of 2 taxane regimens is allowed.
- Participants eligible for PARPi and/or immune checkpoint inhibitor (per local testing and according to investigator’s judgement) are eligible to participate if they have previous exposure to this(these) therapy(ies).
- Prior treatment with any RLT (approved or investigational) is not allowed
- Prior treatment with a protein degrader compound that targets AR is not allowed
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Israel
- Taiwan
- United States
- Korea, Democratic People's Republic of
- China
- Singapore
- Argentina
- Australia
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Israel; Taiwan; United States; Korea, Democratic People's Republic of; China and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.