Clinical Trial · NCT07562438

Prospective Clinical Trial of 177Lu-P17-088 in the Treatment of Metastatic Castration-Resistant Prostate Cancer

Overview

PSMA is an ideal target for precision diagnosis and treatment of prostate cancer. P17-088 is a novel albumin-binding PSMA-targeted radioligand. This study aims to explore the safety and efficacy of 177Lu-labeled P17-088 for treating patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC).

Sponsor

First Affiliated Hospital of Fujian Medical University

Phase

Phase 2

Contacts

Guochang Wang, MD (CONTACT)

guochang1007@163.com

+86-0591-87981619

Weibing Miao, MD (CONTACT)

miaoweibing@126.com

+86-0591-87981618

Weibing Miao, MD (STUDY_CHAIR)

ClinicalTrials.gov

NCT07562438

Drug / Compound

P17-088

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Eligibility

Inclusion

Patients who have not received, refused, or progressed after receiving at least 1 but no more than 2 prior taxane-based therapies. The taxane regimen must have included exposure for at least 2 cycles. Patients who received only one taxane may be included if the investigator deems them unsuitable for a second taxane (e.g., due to frailty assessed by geriatric/comorbidity evaluation or intolerance).
At least one measurable lesion per RECIST 1.1 criteria OR at least one bone metastasis per PCWG3 criteria.
Patients who have progressed after receiving at least one novel androgen axis drug \[NAAD\] (e.g., abiraterone, enzalutamide).
Radiographic progression: Either two or more new bone lesions on bone scan, or soft tissue lesion progression as per RECIST 1.1 criteria. Progression based on symptoms alone is insufficient for mCRPC diagnosis and requires further evaluation.
Metastatic Castration-Resistant Prostate Cancer (mCRPC) mCRPC refers to prostate cancer that progresses despite serum testosterone at castrate levels (\< 50 ng/dL or 1.7 nmol/L), meeting at least one of the following criteria:

Exclusion

Prior EBRT involving extensive bone marrow (\>25%);
Superscan on bone scintigraphy;
Brain metastasis at screening, except:
Patients who received radionuclide therapy (Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, Lutetium-177) within 6 months, or any External Beam Radiation Therapy (EBRT) within 2 months prior to the first dose;