OncoMatch/Clinical Trials/NCT07047118
A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
Is NCT07047118 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including JSB462 and AAA617 for prostatic cancer, castration-resistant.
Treatment: JSB462 · AAA617 — This Phase II study aims to evaluate the efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg QD doses + lutetium (177Lu) vipivotide tetraxetan (hereafter referred as AAA617) compared with AAA617 (control) in participants with metastatic Castration Resistant Prostate Cancer (mCRPC) with prior exposure to at least 1 Androgen Receptor Pathway Inhibitor (ARPI) and 0-2 taxane regimens and to select the recommended dose of the combination for phase III. Towards that end, the totality of the efficacy, safety, tolerability and pharmacokinetic (PK) data from participants randomized in the study will be evaluated.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Biomarker criteria
Required: FOLH1 PSMA expression positive by [68Ga]Ga-PSMA-11 PET/CT
Participants must be [68Ga]Ga-PSMA-11 PET/CT scan positive and eligible as determined by the sponsor's central reader.
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: second generation ARPI — metastatic/advanced
Participant must have prior exposure to at least one second generation ARPI in the metastatic/advanced setting.
Must have received: PARP inhibitor
Participants eligible for PARPi ... are eligible to participate if they have previous exposure to this(these) therapy(ies).
Must have received: immune checkpoint inhibitor
Participants eligible for ... immune checkpoint inhibitor ... are eligible to participate if they have previous exposure to this(these) therapy(ies).
Cannot have received: radioligand therapy
Prior treatment with any RLT (approved or investigational) is not allowed
Cannot have received: protein degrader compound that targets AR
Prior treatment with a protein degrader compound that targets AR is not allowed
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Cancer And Blood Spclsts of AZ · Casa Grande, Arizona
- Highlands Oncology Group · Fayetteville, Arkansas
- City of Hope National Medical · Duarte, California
- Providence Saint Johns Health Ctr · Santa Monica, California
- Rocky Mountain Cancer Centers · Denver, Colorado
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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