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)
Study of Investigational Combinations for Prostate Cancer
Nabil Adra, MD
Primary Investigator
Brief description of study
This Phase II study aims to evaluate the efficacy and safety of the combination of JSB462 (alsoknown as luxdegalutamide) at 100 mg and 300 mg QD doses + lutetium ( 177 Lu) vipivotidetetraxetan (hereafter referred as AAA617) compared with AAA617 (control) in participants with mCRPC with prior exposure to at least 1 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 PK data from participants randomized in the study will be evaluated.
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Detailed description of study
This is an open-label, global, multicenter, randomized phase II study evaluating the efficacy, safety and tolerability of two dose regimens of JSB462 (100 mg QD and 300 mg QD) combined with AAA617 as compared to control with AAA617 in approximately 130 adult participants with PSMA-positive mCRPC. Randomization will be stratified by prior taxane (yes vs no), and visceral metastases (yes vs. no). The study consists of a screening period, a randomization period, a treatment period, a post- treatment safety follow-up followed by a long-term follow-up period. JSB462 administration starts at day 1 of randomization, whereas AAA617 administration starts at day 1 of treatment period. Participants in arm 1 and arm 2 will therefore receive JSB462 during the 14-day randomization period before first administration of AAA617.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Psma-Positive Metastatic Castration Resistant Prostate Cancer (Mcrpc)
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Age: 18 years - 100 years
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Gender: Male
Key Inclusion Criteria:
1. Adult male participants with histologically and/or cytologically confirmed
adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are
not eligible.
2. An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade ≤2.
3. 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.
4. Participants must be gallium (68 Ga) gozetotide PET/CT scan positive and eligible as
determined by the sponsor’s central reader.
5. Participant must have prior exposure to at least one second generation ARPI in the
metastatic/advanced setting.
6. Previous treatment with a maximum of 2 taxane regimens is allowed.
7. 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).
Novartis Confidential Page 18 of 207
Amended Protocol Version 01 (Clean) Protocol No. CJSB462B12201
Key Exclusion Criteria:
1. Prior treatment with any RLT (approved or investigational) is not allowed
2. Prior treatment with a protein
This study investigates the effects of combining two investigational medications for treating prostate cancer that has spread and is resistant to standard treatments. The study focuses on adult male patients with prostate cancer that shows positive results on a specific type of scan. The purpose is to find out how well the combination works and how safe it is compared to a single medication.
Participants will be divided into two study arms. Some will receive a combination of two investigational medications, while others will receive only one. The study will involve a screening period, a randomization period, a treatment period, and follow-up periods. Participants will start taking one of the medications during the randomization period before receiving the second medication.
- Who can participate: Adult male patients with prostate cancer that has spread and is resistant to prior treatments may participate. They must have a positive PSMA result from a PET/CT scan and have been previously treated with specific medications such as chemotherapy or hormone therapy.
- Study details: Participants will receive either one or two investigational treatments. They will undergo a series of scans and follow-ups to monitor the effects of the treatment. A placebo, an inactive substance that looks like the investigational treatment but does not contain any active medicine, may be used as a comparison.
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