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
1 other identifier
interventional
153
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2022
Longer than P75 for phase_1
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2022
CompletedFirst Posted
Study publicly available on registry
July 26, 2022
CompletedStudy Start
First participant enrolled
August 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
April 15, 2025
April 1, 2025
4.4 years
July 13, 2022
April 11, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
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
AEs+SAEs
from the first drug administration to within 30 days for the last treatment dose
up to 24 months
Secondary Outcomes (7)
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)
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)
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)
Objective Response Rate (ORR)
up to 24 months
Disease control rate (DCR)
up to 24 months
- +2 more secondary outcomes
Study Arms (1)
HRS-1167
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
Guangxi Medical University Affiliated Tumor Hosipital
Nanning, Guangxi, 530021, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangzhou, 510120, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330209, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Liaoning Cancer Hospital
Shenyang, Liaoning, 110042, China
Qilu Hospital of Shandong University
Jinan, Shangdong, 250062, China
Shandong Cancer Hospital
Jinan, Shangdong, 250117, China
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646099, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China
Zhejiang Cancer Hospital
Hangzhou, Zhengjiang, 310022, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2022
First Posted
July 26, 2022
Study Start
August 23, 2022
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
April 15, 2025
Record last verified: 2025-04