A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

Conditions

• Prostatic Cancer, Castration-Resistant

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• JSB462 — DRUG
  Administered orally, daily and continuously (100 mg or 300 mg QD) until disease progression per PCWG3-modified RECIST v1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision
• AAA617 — DRUG
  administered at 7.4 GBq intravenously every 6 weeks for up to 6 doses, unless there is disease progression per PCWG3-modified RECIST v1.1 as assessed by the investigator, the occurrence of unacceptable toxicities, death, participant decision or investigator decision

Study Details

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.

Key Dates

Start date

Jul 3, 2025

Status verified

Jun 2026

Primary completion

Jul 16, 2027

Completion

May 14, 2028

Study Design

Enrollment

138 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1
  JSB462 100 mg QD + AAA617 7.4 GBq Q6W
• Experimental: Arm 2
  JSB462 300 mg QD + AAA617 7.4 GBq Q6W
• Active Comparator: Arm 3
  AAA617 7.4 GBq Q6W

Primary Outcome Measure

Prostate Specific Antigen 50 (PSA50) Rate [ Time Frame: From date of randomization till 30 days safety fup, assessed up to approximately 30 months ]

Locations (11)

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