QLC5508 in Participants With Metastatic Prostate Cancer

NCT07632690 — Phase 3, Not yet recruiting, 700 participants, Qilu Pharmaceutical Co., Ltd.

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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).

Registry	NCT07632690
Status	Not yet recruiting
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	700 (Estimated)
Sponsor	Qilu Pharmaceutical Co., Ltd. (Industry)
Conditions	Prostate Cancer
Interventions	QLC5508, Docetaxel (Drug)
Dates	start 2026-06-20 (estimated), primary completion 2028-06-20 (estimated), completion 2030-11-20 (estimated), first posted 2026-06-08, last updated 2026-06-08

-Summary

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).

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+Arms and interventions

Arm	Type	Interventions	Description
QLC5508 arm	Experimental	Drug: QLC5508
Docetaxel arm	Active comparator	Drug: Docetaxel

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)

+Outcome measures

Primary outcomes

Radiographic Progression Free Survival (rPFS) [Up to approximately 36 months]

Secondary outcomes

Overall Survival (OS) [Up to approximately 36 months]
Objective Response Rate (ORR) [Up to approximately 36 months]
Prostate-specific Antigen (PSA) Response Rate [Up to approximately 36 months]
Time to Prostate-specific Antigen (PSA) Progression [Up to approximately 36 months]
Time to Pain Progression (TTPP) [Up to approximately 36 months]
Number of Participants Who Experienced at Least One Adverse Event (AE) [Up to approximately 36 months]

+Eligibility

Sex: Male, ages: 18 Years to any

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.

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