Clinical Evaluation of SRT-017 in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer

Sponsor
Affiliated Hospital of Jiangnan University
Study ID
NCT07798778
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SRT-017 — DRUG
    Investigational PSMA-targeted radiopharmaceutical, administered intravenously for male patients with metastatic castration-resistant prostate cancer (mCRPC). Dosing and administration will follow the study protocol.

Study Details

This is a single-arm, open-label study to evaluate the safety, tolerability and preliminary anti-tumor efficacy of SRT-017 radioligand therapy in patients with PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC). All eligible participants will receive SRT-017 intravenous treatment. The primary objectives are to assess safety and tolerability. Secondary objectives include radiation dosimetry, pharmacokinetics, and preliminary antitumor activity.

Key Dates

First listed
Sep 1, 2026
Start date
Jul 30, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SRT-017-001 Radioligand Therapy Group
    Male patients with metastatic castration-resistant prostate cancer (mCRPC) will receive investigational PSMA-targeted radiopharmaceutical SRT-017-001 by intravenous injection according to the study protocol.

Primary Outcome Measure

Outcome Measure：Percentage of Participants With Confirmed PSA Response (≥50% PSA Decline) [ Time Frame: From first study drug administration up to 12 weeks post-treatment ]

Central Contacts

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