Advanced Solid TumorsPhase 1NCT05473624
Study of HRS-1167 as Monotherapy in Patients With Advanced Solid Tumors
A Phase 1 study testing HRS-1167 in people with Advanced Solid Tumors, run by Jiangsu HengRui Medicine Co., Ltd. at 20 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- HRS-1167
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 20 sitesChina
- Study dates
- 23 Aug 2022to 31 Dec 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
China20 sites, 20 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Lingying Wu, Doctor, +86-010-87788996, wulingying@csco.org.cn
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
Jiuwei Cui, Doctor
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Jing Wang, Doctor
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Shusuan Jiang, Doctor
- Recruiting
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Yongsheng Li, Doctor
- Recruiting
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangzhou, 510120
Ying Wang, Doctor
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhengjiang, 310022
Xiaojia Wang, Doctor
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Hui Chen, Doctor
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shangdong, 250062
Shuwen Yu, Doctor
- Recruiting
Shandong Cancer Hospital
Jinan, Shangdong, 250117
Yuping Sun, Doctor
- Recruiting
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646099
Qinglian Wen, Doctor
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330209
Bin Fu, Doctor
- Recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
Yongmei Yin, Doctor
- Recruiting
Guangxi Medical University Affiliated Tumor Hosipital
Nanning, Guangxi, 530021
He Wang, Doctor
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Funan Liu, Doctor
- Recruiting
Liaoning Cancer Hospital
Shenyang, Liaoning, 110042
Danbo Wang, Doctor
- Recruiting
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Wei Wang, Doctor
- Recruiting
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013
Hongwei Zhao, Doctor
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Xu Wang, Doctor
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Min Yan, Doctor
About this study
Official title: 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.
- Conditions
- Advanced Solid Tumors
- Being tested
- HRS-1167
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-1167Drug
Participants will receive HRS-1167.
| Study group | Role | What they receive |
|---|---|---|
| HRS-1167 | Experimental | Not described Receives: Drug: HRS-1167 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT) of HRS-1167
Measured: up to 24 days
Maximum tolerated dose (MTD) of HRS-1167
Measured: up to 24 months
Recommended Phase II Dose (RP2D) of HRS-1167
Measured: up to 24 months
AEs+SAEs
from the first drug administration to within 30 days for the last treatment dose
Measured: up to 24 months
Secondary outcomes (7)
Evaluation of pharmacokinetic parameter of HRS-1167: Cmax
The concentration of HRS-1167 in plasma will be determined (Cmax will be derived).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: up to 24 months
Disease control rate (DCR)
Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1.
Measured: 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.
Measured: up to 24 months
Progression Free Survival (PFS)
Time from C1D1 to first assessment of disease progression or death, whichever is earlier.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start23 Aug 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473624
- Sponsor's protocol ID
- HRS-1167-I-101
- Status last verified
- Apr 2025
- First submitted
- 13 Jul 2022
- Last updated
- 15 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided