Qilu Pharmaceutical Initiates First-in-Class Trispecific T-Cell Engager QLF41131 Clinical Trial in Advanced Prostate Cancer

Jun 16, 2026 15:21 CST Updated 15:21

Qilu Pharmaceutical

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June 16, the official website of the Drug Clinical Trial Registration and Information Publicity Platform shows that Qilu Pharmaceutical has initiated a study to evaluateQLF4113 inAdvanced Prostate CancerAn Open-Label, Multicenter Phase I Clinical Study Evaluating Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity in Study ParticipantsResearch(Registration No.:CTR20262372）。

Source:Drug Clinical Trial Registration and InformationOfficial Website of the Publicity Platform

The Phase Ia of this study isMonotherapy Dose Escalation Study, aiming to assessSafety and Tolerability of QLF41131 Monotherapy in Participants with Advanced Prostate Cancer,Determine the Recommended Phase II Dose（RP2D）; Stage Ib isMonotherapy Efficacy Expansion Study, aiming toAssessmentProstate-Specific Antigen of QLF4113 Monotherapy in Participants with Advanced Prostate Cancer（PSA）50 Response Rate and Objective Response Rate（ORR）。

The study plans to enroll 248 subjects, with the primary endpoint being Maximum Tolerated Dose of QLF4113 Monotherapy in Participants with Advanced Prostate Cancer（MTD）/Maximum Administered Dose（MAD）and RP2D, and adverse events（AE）incidence and severity.

QLF41131 is a product independently developed by Qilu PharmaceuticalTCE Triple Antibodies，Targeting CD3, CD2, and PSMA. Currently, no drugs with the same target mechanism have been approved for marketing globally, and QLF41131 is expected to become a first-in-class therapy in this field.（first-in-class）or equivalent best-in-class（best-in-class）innovative therapies.

This drug effectively and durably inhibits tumor cell growth through an innovative mechanism, demonstrating potent antitumor activity and a favorable safety profile in various preclinical models of prostate cancer. It can sustainably activate antitumor immunity, holding promise for overcoming the resistance bottlenecks associated with existing therapies.

Editor: Yueya

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