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NCT Number: NCT07104110

Study of QLH12016 in Combination With Novel Hormonal Agent in Subjects With Advanced Prostate Cancer

This study is designed to determine if experimental treatment with QLH12016 in combination with novel hormonal agent (NHA) is safe, tolerable, and has anti-cancer activity in patients with advanced prostate cancer.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed the informed consent form.
  • Male, aged ≥ 18 years.
  • Life expectancy ≥ 3 months.
  • Histologically or cytologically confirmed prostate adenocarcinoma.
  • Metastatic prostate cancer.
  • Organ function meet protocol requirements.
  • Recovered from all reversible AEs related to previous anticancer treatments.

Exclusion criteria

  • Previous treatment with the following drugs:
  • AR PROTAC class drugs.
  • Other systemic anticancer therapy within 3 weeks or 5 half-lives prior to the first administration of the study treatment.
  • Taditional Chinese medicine with anti-tumor indications within 2 weeks prior to the first administration of the study treatment.
  • Drugs that may cause drug-drug interactions (DDI) with the study treatment.
  • Drugs known to prolong the QT interval or potentially cause torsades de pointes ventricular tachycardia
  • Presence of central nervous system metastases, leptomeningeal metastasis, or spinal cord compression.
  • Radiation therapy involving more than 25% of bone marrow within 4 weeks prior to the first administration of the investigational medicinal product; local radiation therapy within 2 weeks prior to the first administration of the investigational medicinal product.
  • Treatment with other investigational drugs or major surgery within 4 weeks.
  • Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption.
  • With severe cardiovascular or cerebrovascular diseases or related history.
  • Active, uncontrolled infections.
  • History of other significant malignancies within 5 years.
  • Moderate to severe pulmonary disease significantly affecting lung function.
  • According to the investigator's judgment, there are comorbidities that seriously endanger subject safety or affect the subject's ability to complete the study.
  • Allergy to any of the investigational medicinal products or their components.

Treatment and study plan

QLH12016

Drug

oral AR PROTAC

Abiraterone Acetate

Drug

oral CYP17 inhibitor

Enzalutamide

Drug

oral androgen receptor inhibitor

Primary outcomes

  1. The number of subjects with adverse events/serious adverse events (Phase Ib)

    Time frame: Throughout phase Ib (approximately 1 year)

    Number of patients with adverse events and with serious adverse events including abnormal clinical observations, abnormal ECG parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline

  2. The number of subjects with dose-limiting toxicity (DLT), as defined in the protocol (Phase Ib)

    Time frame: From first dose of study treatment until the end of Cycle 1.

    A DLT occurs during Cycle 1 (the DLT assessment period) that is assessed as related to study treatment.

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

    Time frame: Throughout phase Ib (approximately 1 year)

    RP2D will be selected upon safety, PK and efficacy data.

  4. Objective Response Rate (ORR) (Phase II)

    Time frame: From time of Informed Consent to confirmed progressive disease (approximately 1 year)

    Best response until progression, as defined by RECIST 1.1 and PCWG3

  5. Objective Response Rate (ORR) (Phase II)

    Time frame: From time of Informed Consent to confirmed progressive disease (approximately 1 year).

    Proportion of subjects with ≥ 50% PSA decrease

Study contacts

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

Wanhai Xu, PHD

CONTACT

[email protected]

0451-86605612

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 Antitumor Activity of QLH12016 in Combination With Novel Hormonal Agent in Subjects With Advanced Prostate Cancer

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 5, 2025
Registry last updated
Aug 5, 2025

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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