NCT07632690Not yet recruitingPhase 3
QLC5508 in Participants With Metastatic Prostate Cancer
A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Trial Comparing QLC5508 Versus Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Have Progressed After Treatment With Novel Hormonal Agents (NHA).
Source: ClinicalTrials.gov · Last updated 8 Jun 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 700 (estimated)
- First submitted
- 2 Jun 2026
- Start date
- 20 Jun 2026
- Primary completion date
- 20 Jun 2028
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Diseases
- Prostate cancer
- NCT number
- NCT07632690
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 700
- From 20 Jun 2026 to the primary completion date, 20 Jun 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.