3D1015 Injection for Patients With mCRPC
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorChunjing Yu
About this trial
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.
Eligibility criteria
Qualifiers
Capable of understanding and providing written informed consent. Willing and able to comply with all study requirements, treatments, and scheduled visits.
Male, aged 18 years or older.
Histologically or cytologically confirmed prostate adenocarcinoma.
Castrate levels of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L).
Disqualifiers
Receipt of other systemic anti-cancer therapies within 4 weeks prior to study entry.
Life expectancy of < 6 months, as assessed by the investigator.
A superscan as seen in the baseline bone scan.
Presence of clinically significant, uncontrolled, or unstable concurrent medical conditions that may compromise patient safety or study assessments.
Trial design
Treatments tested in this trial
- Lu 177-PSMA-3D1015 Injection
Treatment groups
8 Participants
are divided into 1 treatment groupSponsors and collaborators
Chunjing Yu
Lead sponsor
Affiliated Hospital of Jiangnan University
Sponsor institution
Source ClinicalTrials.gov