Health TrialsbyHealthPanel

QLC5508 in Participants With Metastatic Prostate Cancer

ConditionProstate Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorQilu Pharmaceutical Co., Ltd.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • QLC5508

    Drug

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

  • Docetaxel

    Drug

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

Treatment groups

700 Participants
are divided into 2 treatment groups
Group A: QLC5508 armExperimental treatment 1 intervention
Group B: Docetaxel armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Radiographic Progression Free Survival (rPFS)

Time frame
Up to approximately 36 months

Secondary outcomes

1

Overall Survival (OS)

Time frame
Up to approximately 36 months
2

Objective Response Rate (ORR)

Time frame
Up to approximately 36 months
3

Prostate-specific Antigen (PSA) Response Rate

Time frame
Up to approximately 36 months
4

Time to Prostate-specific Antigen (PSA) Progression

Time frame
Up to approximately 36 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qilu Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: