NCT07104110Not yet recruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 5 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 29 Jul 2025
- Start date
- Oct 2025
- Primary completion date
- Oct 2027
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Diseases
- Prostate cancer
- NCT number
- NCT07104110
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 50
- From Oct 2025 to the primary completion date, Oct 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
- Allergy to any of the investigational medicinal products or their components.
Lab values
- 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
Other
- Presence of central nervous system metastases, leptomeningeal metastasis, or spinal cord compression.
- According to the investigator's judgment, there are comorbidities that seriously endanger subject safety or affect the subject's ability to complete the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.