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Expanded Access Treatment with [Lu-177]-PNT2002 for Adult Patients with Prostate-Specific Membrane Antigen (PSMA)-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06033001 · Status: TEMPORARILY_NOT_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2025-01-13

No results posted yet for this study

Summary

The purpose of this program is to provide access to \[Lu-177\]-PNT2002 to patients who have been diagnosed with prostate-specific membrane antigen (PMSA)-positive castration-resistant prostate cancer (mCRPC). Patients must have received at least 1 prior androgen pathway inhibitor (ARPI) and cannot be treated by currently available drugs or clinical trials.

In this program participants will be administered \[Lu-177\]-PNT2002 intravenously every 8 weeks (about every 2 months) for 4 cycles, or 8 months of total treatment. During treatment, participants will be monitored with routine laboratory tests such as:

* Hematology blood tests
* Clinical Chemistry blood tests
* Testosterone/Prostate Antigen levels blood test
* Vital signs
* Imaging
* ECG

Conditions

  • Castration-Resistant Prostatic Cancer

Interventions

DRUG

[Lu-177]-PNT2002

\[Lu-177\]-PNT2002, is a radiopharmaceutical investigational drug. \[Lu-177\]-PNT2002 targets a specific protein that is located on the surface of prostate cancer cells called PSMA. \[Lu-177\]-PNT2002 delivers radiation to your cancer by binding to the PSMA which helps destroy the cancer cells. \[Lu-177\]-PNT2002 is administered intravenously every 8 weeks (about every 2 months) for 4 cycles, or 8 months of total treatment.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06033001 on ClinicalTrials.gov