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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Lu 177-PSMA-3D1015 Injection
Drug3D1015 is administered intravenously at an individualized dose.
Treatment groups
8 Participants
are divided into 1 treatment groupGroup A: Lu 177-PSMA-3D1015Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
Safety and tolerability will be evaluated by monitoring the incidence and severity of TEAEs.
Time frame
From first dose of study drug through end of treatment (~36-48 weeks)2
Occurrence of Dose-Limiting Toxicities (DLTs)
Number of participants experiencing dose-limiting toxicities (DLTs) .
Time frame
From first dose of study drug through end of treatment (~36-48 weeks)3
Absorbed Dose
Absorbed dose to the whole body, critical organs (e.g., kidneys, salivary glands), and tumor lesions assessed via serial imaging data.
Time frame
From first dose of study drug through end of treatment (~36-48 weeks)4
Effective Half-Life
Effective half-life of the study drug in the whole body, major organs, and tumor lesions determined by serial imaging.
Time frame
From first dose of study drug through end of treatment (~36-48 weeks)Secondary outcomes
1
The proportion of patients with a PSA change from baseline
The effect of Lu 177-PSMA-3D1015 on prostate-specific antigen (PSA) kinetics.
Time frame
From first dose of study drug through end of treatment (~36-48 weeks)2
Objective Response Rate (ORR)
Percentage of participants with a complete response (CR) or partial response (PR).
Time frame
From first dose of study drug through efficacy follow-up period (Up to approximately 5 years)3
Radiographic progression-free survival (rPFS)
rPFS per investigator assessment.
Time frame
From first dose of study drug through efficacy follow-up period (Up to approximately 5 years)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Chunjing Yu
Lead sponsor
Affiliated Hospital of Jiangnan University
Sponsor institution
Source ClinicalTrials.gov