QLC5508 in Participants With Metastatic Prostate Cancer

NCT07632690 | Not Yet Recruiting Phase 3

• 1 other identifier: QLC5508-302
• Study Type: interventional
• Target: 700
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Radiographic Progression Free Survival (rPFS)

  Up to approximately 36 months

Secondary Outcomes (6)

• 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

Study Arms (2)

QLC5508 arm

EXPERIMENTAL

Drug: QLC5508

Docetaxel arm

ACTIVE COMPARATOR

Drug: Docetaxel

Interventions

QLC5508 DRUG

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

QLC5508 arm

Docetaxel DRUG

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

Docetaxel arm

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.
• \. 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.
• \. Known hypersensitivity or allergy to any investigational product or its excipients.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Zhang Lei, B.M.

CONTACT

0086-10-88196391; zlei090903@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 8, 2026
• Study Start (Estimated): June 20, 2026
• Primary Completion (Estimated): June 20, 2028
• Study Completion (Estimated): November 20, 2030
• Last Updated: June 8, 2026

Record last verified: 2026-06