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NCT Number: NCT07632690

QLC5508 in Participants With Metastatic Prostate Cancer

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.

Treatment and study plan

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)

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

  5. Time to Pain Progression (TTPP)

    Time frame: Up to approximately 36 months

  6. Number of Participants Who Experienced at Least One Adverse Event (AE)

    Time frame: Up to approximately 36 months

Study contacts

Contact information is provided by the study sponsor or research team.

Zhang Lei, B.M.

CONTACT

[email protected]

0086-10-88196391

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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).

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Jun 8, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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