Phase 1 3D1015 Injection Trial for Metastatic Castration-Resistant Prostate Cancer
ClinicalTrials.gov Studies
Summary
NIH registered a Phase 1 clinical trial (NCT07537010) investigating 3D1015 Injection (Lu 177-PSMA-3D1015) in adult males with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). The open-label study will evaluate safety, tolerability, and dosimetry of intravenous infusions with dynamically individualized treatment regimens. Secondary objectives include assessing preliminary anti-tumor efficacy and optimal dosing.
What changed
NIH registered a new Phase 1 clinical trial (NCT07537010) for 3D1015 Injection, an investigational radiopharmaceutical targeting PSMA-positive metastatic castration-resistant prostate cancer. The study will enroll adult male participants receiving intravenous infusions with individualized dosing regimens to evaluate safety, tolerability, and dosimetry. Secondary endpoints include preliminary anti-tumor efficacy and optimal dosing exploration.
For clinical investigators and pharmaceutical companies, this registry entry documents an active Phase 1 oncology study in the radiopharmaceutical space. Sponsors considering competing programs in PSMA-targeted prostate cancer therapeutics should monitor this trial's progress. The study represents early-stage clinical development without immediate compliance implications for external parties.
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Apr 18, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
3D1015 Injection for Patients With mCRPC
Phase 1 NCT07537010 Kind: PHASE1 Apr 17, 2026
Abstract
This open-label clinical study investigates 3D1015 Injection (Lu 177-PSMA-3D1015) in adult males with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). Participants will receive intravenous infusions of 3D1015, with treatment regimens dynamically individualized to optimize patient safety and outcomes. The primary objectives are to assess the safety, tolerability, and dosimetry of the injection. Secondary objectives include evaluating preliminary anti-tumor efficacy and exploring the optimal dosing regimen.
Conditions: Metastatic Castration-resistant Prostate Cancer, mCRPC
Interventions: Lu 177-PSMA-3D1015 Injection
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