QLC5508 in Participants With Metastatic Prostate Cancer

Phase 3Not Yet RecruitingNCT07632690

Qilu Pharmaceutical Co., Ltd.700 enrolled

Overview

This is a randomized, open-label, active-controlled, multicenter Phase III trial evaluating QLC5508 versus docetaxel in participants with metastatic castration-resistant prostate cancer (mCRPC) who have progressed after prior treatment with novel hormonal agents (NHAs). Participants are randomized to receive either QLC5508 monotherapy (experimental arm) or docetaxel (control arm). The primary objective is to compare the efficacy of QLC5508 versus docetaxel, as measured by radiographic progression-free survival (rPFS) assessed by an Independent Radiological Review Committee (IRC).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

700

Conditions

Prostate Cancer

Interventions

QLC5508DRUG

2.0 mg/kg Q2W, administered as an IV infusion until disease progression, unacceptable adverse events (AEs), or other cessation of treatment

DocetaxelDRUG

75 mg/m2 Q3W, administered as an IV infusion (up to 10 cycles)

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male, aged ≥18 years. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Life expectancy of at least 3 months. * Histologically or cytologically confirmed adenocarcinoma of the prostate without evidence of small-cell features. * Diagnosis of metastatic castration-resistant prostate cancer (mCRPC). * Prior treatment with novel hormonal agents (NHAs) and documented disease progression. * Adequate organ function. * Recovery from all reversible adverse events (AEs) related to prior anticancer therapies. Exclusion Criteria: * 1\. Prior treatment with a B7-H3-targeted therapy, or with an antibody-drug conjugate (ADC) using a topoisomerase I inhibitor (TOP1i) as the payload, or with any TOP1i-class agent. 2\. History of or current significant cardiovascular or cerebrovascular disease. 3. Active, uncontrolled infection. 4. Concurrent or prior history of another primary malignancy 5. History of interstitial lung disease (ILD) or non-infectious pneumonitis, or current ILD/non-infectious pneumonitis 6. Current hepatic encephalopathy, hepatorenal syndrome, or cirrhosis classified as Child-Pugh class B or worse. 7\. Known hypersensitivity or allergy to any investigational product or its excipients.