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

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

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.

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:

  1. AR PROTAC class drugs.
  2. Other systemic anticancer therapy within 3 weeks or 5 half-lives prior to the first administration of the study treatment.
  3. Taditional Chinese medicine with anti-tumor indications within 2 weeks prior to the first administration of the study treatment.
  4. Drugs that may cause drug-drug interactions (DDI) with the study treatment.
  5. 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.