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Clinical Trials in China / NCT05473624
Recruiting Phase 1

Study of HRS-1167 as Monotherapy in Patients With Advanced Solid Tumors

NCT05473624 · tracked via the Priya Life Science China tracker
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Phase
Phase 1
Started
2022-08-23
Last updated
2025-04-15

Condition(s) studied

Advanced Solid Tumors

Investigational drug(s) / intervention(s)

HRS-1167

HRS-1167: Participants will receive HRS-1167.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18; 2. ECOG performance status 0-1; 3. Life expectancy is not less than 12 weeks; 4. 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; 5. Efficacy expansion part:Ovarian Cancer、Breast Cancer、Pancreatic Cancer、Prostate Cancer or other cancer types with HRR gene mutation; 6. At least one target lesion (except maintenance therapy); 7. Adequate organ and marrow function as defined by the protocol. Exclusion Criteria: 1. Surgery or chemotherapy within 4 weeks of the first dose of study treatment; 2. Subjects that are unable to swallow, or dysfunction of gastrointestinal absorption; 3. Active HBV/HCV/HIV infection; 4. Untreated and/or uncontrolled brain metastases.

Primary outcome measure(s)

Trial sites (20)

FacilityCityRegionStatus
Cancer Hospital Chinese Academy of Medical Sciences Beijing Beijing Municipality Recruiting
Chongqing Cancer Hospital Chongqing Chongqing Municipality Recruiting
Guangxi Medical University Affiliated Tumor Hosipital Nanning Guangxi Recruiting
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University Guangzhou Guangzhou Recruiting
Harbin Medical University Cancer Hospital Harbin Heilongjiang Recruiting
Henan Cancer Hospital Zhengzhou Henan Recruiting
Hunan Cancer Hospital Changsha Hunan Recruiting
Hunan Cancer Hospital Changsha Hunan Recruiting
The First Affiliated Hospital with Nanjing Medical University Nanjing Jiangsu Recruiting
The First Affiliated Hospital of Nanchang University Nanchang Jiangxi Recruiting
The First Hospital of Jilin University Changchun Jilin Recruiting
The First Hospital of China Medical University Shenyang Liaoning Recruiting
Liaoning Cancer Hospital Shenyang Liaoning Recruiting
Qilu Hospital of Shandong University Jinan Shangdong Recruiting
Shandong Cancer Hospital Jinan Shangdong Recruiting
Second Hospital of Shanxi Medical University Taiyuan Shanxi Recruiting
Shanxi Provincial Cancer Hospital Taiyuan Shanxi Recruiting
The Affiliated Hospital of Southwest Medical University Luzhou Sichuan Recruiting
Tianjin Medical University Cancer Institute & Hospital Tianjin Tianjin Municipality Recruiting
Zhejiang Cancer Hospital Hangzhou Zhengjiang Recruiting

More Jiangsu HengRui Medicine Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05473624 on ClinicalTrials.gov ↗ ← All trials in China