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NCT Number: NCT07198633

A Clinical Study of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer

This study is an open-label, multicenter Phase Ib/II clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of QLC5508 in combination with NHA (abiraterone or enzalutamide), QLC5508 in combination with QLH12016, QLC5508 in combination with QLH12016 and NHA (abiraterone or enzalutamide), and QLH12016 in combination with NHA (abiraterone or enzalutamide) in subjects with advanced prostate cancer.

The study consists of two stages:

Phase Ib: is the combination dose-escalation stage, during which the recommended Phase II dose (RP2D) will be determined.

Phase II is the efficacy exploration stage, in which, based on the RP2D established in Phase Ib, the therapeutic efficacy will be further evaluated in the target indication.

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Key information

Conditions

Advanced Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Location status: Recruiting

Location contact

Xin Yao, Doctor

CONTACT

[email protected]

86 022-23340123-2123

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The subject voluntarily agrees to participate and has signed the informed consent form.
  • Male, aged ≥18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
  • Life expectancy of at least 3 months.
  • Histologically or cytologically confirmed adenocarcinoma of the prostate.
  • Radiologically confirmed metastatic prostate cancer.
  • For subjects with mCRPC, serum testosterone must be at castrate levels, and they must have demonstrated either PSA progression or radiographic progression.
  • Must have undergone surgical castration or be willing to receive medical castration.
  • For Phase Ib, subjects must have experienced failure, intolerance, or refusal of standard therapy.
  • Adequate function of major organs as defined by the protocol.
  • Agreement to use effective contraception during the study (except for subjects who have undergone bilateral orchiectomy).
  • Sufficient blood samples must be provided during the screening period for genetic mutation testing.

Exclusion criteria

  • Prior treatment with the following agents: AR PROTAC, abiraterone, enzalutamide, or B7H3-targeted therapies.
  • Presence of central nervous system (CNS) metastases, leptomeningeal metastases, or spinal cord compression requiring hormonal therapy.
  • Receipt of extensive radiotherapy within 4 weeks prior to the first administration of the investigational medicinal product.
  • Treatment with other investigational drugs or major surgery within 4 weeks prior to the first administration of the investigational medicinal product.
  • Presence of factors that may affect drug administration, intake, or absorption.
  • History of epilepsy, or a condition that could provoke seizures within 12 months prior to the first administration of the investigational medicinal product.
  • Known history of substance abuse, alcoholism, or drug addiction; or prior history of significant neurological or psychiatric disorders, including dementia or hepatic encephalopathy.
  • Presence of severe cardiovascular or cerebrovascular disease.
  • Active, uncontrolled infection.
  • Clinically uncontrolled third-space fluid accumulation prior to the first administration of the investigational medicinal product.
  • History of other malignancies within 5 years prior to the first administration of the investigational medicinal product.
  • Presence of moderate to severe pulmonary disease that significantly impairs lung function.
  • For subjects receiving QLC5508, history of non-infectious interstitial lung disease (ILD) or pneumonitis.

Treatment and study plan

QLC5508

Drug

B7H3 ADC; QLC5508 will be administered by injection at the dose and dosing frequency specified in the protocol.

Abiraterone Acetate

Drug

An oral CYP17 inhibitor; abiraterone acetate will be administered orally at the dose and dosing frequency specified in the protocol

Enzalutamide

Drug

An oral androgen receptor inhibitor; enzalutamide will be administered orally at the dose and dosing frequency specified in the protocol.

QLH12016

Drug

An oral androgen receptor PROTAC; QLH12016 will be administered orally at the dose and dosing frequency specified in the protocol

Primary outcomes

  1. Maximum tolerated dose (MTD) (Phase Ib)

    Time frame: At the end of Day 28 after the first dose

    MTD is defined as the previous dose level at which 2 or more out of 2-6 subjects experienced a DLT

  2. Maximum administered dose (MAD)(Phase Ib)

    Time frame: At the end of Day 28 after the first dose

    MAD is defined as follows: a) based on PK data, it is anticipated that at this dose level, the dose-exposure plateau has been reached, b) based on existing safety data, it is judged that dose escalation following this dose level will have a large safety risk or subject intolerance, or c) based on the PK-PD model, it suggested that the optimal target concentration of safety and efficacy has been explored.

  3. recommended phase II dose (RP2D) (Phase Ib)

    Time frame: Through phase Ib completion, an average of 1 year.

    The RP2D will be comprehensively evaluated based on the safety, PK characteristics, and efficacy data from the Phase Ib study.

  4. The incidence and severity of adverse events (AE) (Phase Ib)

    Time frame: Through phase Ib completion, an average of 1 year.

    Incidence and severity of adverse events (AEs) evaluated according to the NCI-CTCAE v5.0

  5. PSA50 response（Phase II）

    Time frame: From Screening to confirmed progressive disease (approximately 1 year)

    Proportion of subjects with ≥ 50% PSA decrease

  6. Objective response rate (ORR) (phase II)

    Time frame: From Screening to confirmed progressive disease (approximately 1 year)

    Best response until progression, as defined by RECIST 1.1 and PCGW3.

Study contacts

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

Xin Yao, PHD

CONTACT

[email protected]

18622221103

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 30, 2025
Registry last updated
Jun 2, 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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