Another Class 1 radiopharmaceutical from Hengrui launches clinical trials

On July 1, the official website of the Drug Clinical Trial Registration and Information Publicity Platform showed that Jiangsu Hengrui Medicine Co., Ltd. registered a drugEvaluationHRS-1738 for PE in prostate cancer patientsPhase I/II Clinical Study on Safety, Pharmacokinetics, Radiation Dosimetry, and Preliminary Diagnostic Efficacy of T/CT Imaging（HRS-1738-101）。

Source:Official website of the Drug Clinical Trial Registration and Information Publicity Platform

This is oneItemNon-randomized, open-label, single-arm phase I/II clinical trial, planning to enroll 50 subjects who will receiveHRS-1738 injection, single dose.

The primary endpoint isAdverse event（AE）and serious adverse events（SAE）, including type, incidence rate, and grading(Assessed according to NCI-CTCAE V5.0 criteria), severity, and relationship to the study drugRelevance, laboratory tests, vital signs, ECG, and ECOG score, etc.Sensitivity, specificity, and positive predictive value at the subject level based on investigator diagnosis compared to histopathology or a reference standard.

HRS-1738 is aTargetRadiolabeled diagnostic agent for PSMA（RDC）. Insight databaseShow that currently HengruiThere are 5 innovative radiopharmaceuticals under development, among which 2 are therapeutic radiopharmaceuticals, namelyHRS-6768（FAP-α RDC）、HRS-4357（PSMA RDC）。