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
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- The number of subjects with adverse events/serious adverse events (Phase Ib)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
QLH12016+NHA
干预措施: QLH12016 (Drug)
QLH12016+NHA
干预措施: abiraterone acetate (Drug)
QLH12016+NHA
干预措施: enzalutamide (Drug)
结局指标
主要结局
The number of subjects with adverse events/serious adverse events (Phase Ib)
时间窗: 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
The number of subjects with dose-limiting toxicity (DLT), as defined in the protocol (Phase Ib)
时间窗: 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.
Recommended phase II dose (RP2D) (Phase Ib)
时间窗: Throughout phase Ib (approximately 1 year)
RP2D will be selected upon safety, PK and efficacy data.
Objective Response Rate (ORR) (Phase II)
时间窗: From time of Informed Consent to confirmed progressive disease (approximately 1 year).
Proportion of subjects with ≥ 50% PSA decrease
次要结局
未报告次要终点