Study of HRS-1167 as Monotherapy in Patients With Advanced Solid Tumors
- Registration Number
- NCT05473624
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief Summary
This study is designed to determine if treatment with HRS-1167 alone is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 153
- Age ≥ 18；
- ECOG performance status 0-1;
- Life expectancy is not less than 12 weeks;
- Dose escalation and PK expansion part: Subjects diagnosed with advanced solid malignancies who are refractory to standard therapies or for which no standard therapy exists；
- Efficacy expansion part：Ovarian Cancer、Breast Cancer、Pancreatic Cancer、Prostate Cancer or other cancer types with HRR gene mutation；
- At least one target lesion (except maintenance therapy);
- Adequate organ and marrow function as defined by the protocol.
- Surgery or chemotherapy within 4 weeks of the first dose of study treatment；
- Subjects that are unable to swallow, or dysfunction of gastrointestinal absorption；
- Active HBV/HCV/HIV infection;
- Untreated and/or uncontrolled brain metastases.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HRS-1167 HRS-1167 -
- Primary Outcome Measures
Name Time Method Dose-limiting toxicity (DLT) of HRS-1167 up to 24 days AEs+SAEs up to 24 months from the first drug administration to within 30 days for the last treatment dose
Maximum tolerated dose (MTD) of HRS-1167 up to 24 months Recommended Phase II Dose (RP2D) of HRS-1167 up to 24 months
- Secondary Outcome Measures
Name Time Method Evaluation of pharmacokinetic parameter of HRS-1167: AUC At Cycle 0 Day 1, Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1 (each cycle is 21 days) The concentration of HRS-1167 in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered.
Objective Response Rate (ORR) up to 24 months Complete response + Partial response (CR+PR) based on RECIST 1.1.
Evaluation of pharmacokinetic parameter of HRS-1167: Cmax At Cycle 0 Day 1, Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1 (each cycle is 21 days) The concentration of HRS-1167 in plasma will be determined (Cmax will be derived).
Evaluation of pharmacokinetic parameter of HRS-1167: Tmax At Cycle 0 Day 1, Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1 (each cycle is 21 days) The concentration of HRS-1167 in plasma will be determined (Tmax will be derived).
Disease control rate (DCR) up to 24 months Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1.
Duration of response (DoR) up to 24 months Time from documentation of tumor response to disease progression assessed among patients who had an objective response.
Progression Free Survival (PFS) up to 24 months Time from C1D1 to first assessment of disease progression or death, whichever is earlier.
Trial Locations
- Locations (19)
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Chongqing Cancer Hospital
🇨🇳Chongqing, Chongqing, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Second Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
Shanxi Provincial Cancer Hospital
🇨🇳Taiyuan, Shanxi, China
Guangxi Medical University Affiliated Tumor Hosipital
🇨🇳Nanning, Guangxi, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital with Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Tianjin Medical University Cancer Institute & Hospital
🇨🇳Tianjin, Tianjin, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
🇨🇳Guangzhou, Guangzhou, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Liaoning Cancer Hospital
🇨🇳Shenyang, Liaoning, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shangdong, China
Shandong Cancer Hospital
🇨🇳Jinan, Shangdong, China
The Affiliated Hospital of Southwest Medical University
🇨🇳Luzhou, Sichuan, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhengjiang, China