RecruitingEarly Phase 1NCT05603559

177Lu-P17-087/177Lu-P17-088 in Patients With Metastatic Castration-resistant Prostate Cancer

Safety, Dosimetry and Dose-escalation of 177Lu-P17-087/177Lu-P17-088 in Patients With Metastatic Castration-resistant Prostate Cancer

Sponsor

Peking Union Medical College Hospital

Enrollment

30 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

Metastatic Castration-resistant Prostate Cancer

Summary

This is a pilot study to assess the safety and measure image-based absorbed dose of 177Lu-P17-087/177Lu-P17-088 in patients with metastatic castration-resistant prostate cancer (mCRPC) who will undergo radioliagnd therapy using 177Lu-P17-087/177Lu-P17-088. All patients underwent whole-body 68Ga-PSMA PET/CT for selection and accepted intravenous injection with single dose 1.1 GBq (30 mCi) of 177Lu-P17-087/177Lu-P17-088 within one week, then monitored at 1.5 hours, 4 hours, 24 hours, 48 hours, 72 hours, 120 hours and 168 hours after 177Lu-P17-087/177Lu-P17-088 administration with serial whole body planar and SPECT/CT imaging.Following this initial safety assessment, the study will proceed to a dose-escalation phase designed to further evaluate safety and determine the optimal therapeutic activity. The dose-escalation phase will enroll patients into three sequential cohorts: a 1.11 GBq (30 mCi) dose group, a 2.96 GBq (80 mCi) dose group, and a 4.44 GBq (120 mCi) dose group.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study tests radioactive drugs called 177Lu-P17-087 and 177Lu-P17-088 in men with metastatic castration-resistant prostate cancer (cancer that has spread and no longer responds to hormone therapy). These drugs are designed to find and destroy cancer cells that show high PSMA expression (a protein found on prostate cancer cells). **You may be eligible if...** - You have metastatic prostate cancer that has progressed despite hormone therapy and/or chemotherapy - Your cancer shows high PSMA expression on a PET/CT scan done within one week before treatment **You may NOT be eligible if...** - Your tumors do not show sufficient PSMA expression on the PET/CT scan - You have serious kidney problems or very low blood counts - You have received certain prior radioligand therapies - You have brain metastases or serious concurrent illnesses Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG1.1 GBq (30 mCi) of 177Lu-P17-087

All patients were intravenous injected with single dose 1.1 GBq (30 mCi) of 177Lu-P17-087 then monitored at 1.5 hours, 4 hours, 24 hours, 48 hours, 72 hours, 120 hours and 168 hours post-injection.

DRUG1.1 GBq (30 mCi) of 177Lu-P17-088

All patients were intravenous injected with single dose 1.1 GBq (30 mCi) of 177Lu-P17-088 then monitored at 1.5 hours, 4 hours, 24 hours, 48 hours, 72 hours, 120 hours and 168 hours post-injection.