QLC5508 and QLH12016 with other anti-tumor therapies in advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, multicenter Phase Ib/II trial in men with metastatic or castration-resistant prostate cancer. It explores safety, tolerability, pharmacokinetics, and early anti-tumor activity of QLC5508 in combination with abiraterone or enzalutamide, QLC5508 with QLH12016, and QLH12016 with abiraterone or enzalutamide, as well as dose escalation to establish a recommended Phase II dose. Phase Ib will determine the RP2D, followed by Phase II to evaluate efficacy using the RP2D. The study will enroll adults with adequate organ function and ECOG 0-1, who have progressed on or after standard therapies.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tianjin Medical University Cancer Institute & Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Xin Yao, PHD
• Email: yaoxin@tjmuch.com
• Phone: 18622221103

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.