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

A Phase I, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HRS-1167 as Monotherapy in Patients With Advanced Solid Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: HRS-1167

• Study Type: Interventional
• Enrollment (Estimated): 153
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Quanren Wang, M.D; Phone Number: +86 18036618570; Email: quanren.wang@hengrui.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Cancer Hospital Chinese Academy of Medical Sciences
      • Contact: Lingying Wu, Doctor; Phone Number: +86-010-87788996; Email: wulingying@csco.org.cn
  • Chongqing
    • Chongqing, Chongqing, China, 400030
      • Recruiting
      • Chongqing Cancer Hospital
      • Principal Investigator: Yongsheng Li, Doctor
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Recruiting
      • Guangxi Medical University Affiliated Tumor Hosipital
      • Principal Investigator: He Wang, Doctor
  • Guangzhou
    • Guangzhou, Guangzhou, China, 510120
      • Recruiting
      • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
      • Principal Investigator: Ying Wang, Doctor
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Recruiting
      • Harbin Medical University Cancer Hospital
      • Principal Investigator: Hui Chen, Doctor
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Recruiting
      • Henan Cancer Hospital
      • Principal Investigator: Min Yan, Doctor
  • Hunan
    • Changsha, Hunan, China, 410013
      • Recruiting
      • Hunan Cancer Hospital
      • Principal Investigator: Shusuan Jiang, Doctor
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • The First Affiliated Hospital with Nanjing Medical University
      • Principal Investigator: Yongmei Yin, Doctor
  • Jiangxi
    • Nanchang, Jiangxi, China, 330209
      • Recruiting
      • The First Affiliated Hospital of NanChang University
      • Principal Investigator: Bin Fu, Doctor
  • Jilin
    • Changchun, Jilin, China, 130021
      • Recruiting
      • The First Hospital of Jilin University
      • Principal Investigator: Jiuwei Cui, Doctor
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • Recruiting
      • The First Hospital of China Medical University
      • Principal Investigator: Funan Liu, Doctor
    • Shenyang, Liaoning, China, 110042
      • Recruiting
      • Liaoning Cancer Hospital
      • Principal Investigator: Danbo Wang, Doctor
  • Shangdong
    • Jinan, Shangdong, China, 250062
      • Recruiting
      • Qilu Hospital of Shandong University
      • Principal Investigator: Shuwen Yu, Doctor
    • Jinan, Shangdong, China, 250117
      • Recruiting
      • Shandong Cancer Hospital
      • Principal Investigator: Yuping Sun, Doctor
  • Shanxi
    • Taiyuan, Shanxi, China, 030013
      • Recruiting
      • Shanxi Provincial Cancer hospital
      • Principal Investigator: Hongwei Zhao, Doctor
    • Taiyuan, Shanxi, China, 030001
      • Recruiting
      • Second Hospital of Shanxi Medical University
      • Principal Investigator: Wei Wang, Doctor
  • Sichuan
    • Luzhou, Sichuan, China, 646099
      • Recruiting
      • The Affiliated Hospital of Southwest Medical University
      • Principal Investigator: Qinglian Wen, Doctor
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Institute & Hospital
      • Principal Investigator: Xu Wang, Doctor
  • Zhengjiang
    • Hangzhou, Zhengjiang, China, 310022
      • Recruiting
      • Zhejiang Cancer Hospital
      • Principal Investigator: Xiaojia Wang, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRS-1167	Drug: HRS-1167; Participants will receive HRS-1167.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AEs+SAEs	from the first drug administration to within 30 days for the last treatment dose	up to 24 months
Dose-limiting toxicity (DLT) of HRS-1167		up to 24 days
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

Outcome Measure	Measure Description	Time Frame
Evaluation of pharmacokinetic parameter of HRS-1167: Cmax	The concentration of HRS-1167 in plasma will be determined (Cmax will be derived).	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)
Evaluation of pharmacokinetic parameter of HRS-1167: Tmax	The concentration of HRS-1167 in plasma will be determined (Tmax will be derived).	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)
Evaluation of pharmacokinetic parameter of HRS-1167: AUC	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.	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)
Objective Response Rate (ORR)	Complete response + Partial response (CR+PR) based on RECIST 1.1.	up to 24 months
Disease control rate (DCR)	Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1.	up to 24 months
Duration of response (DoR)	Time from documentation of tumor response to disease progression assessed among patients who had an objective response.	up to 24 months
Progression Free Survival (PFS)	Time from C1D1 to first assessment of disease progression or death, whichever is earlier.	up to 24 months

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 13, 2022
• First Submitted That Met QC Criteria: July 24, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: HRS-1167-I-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No