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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05473624
- Acronym / sponsor ID
- HRS-1167-I-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRS-1167 | Experimental | Drug: HRS-1167 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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；
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-1167Participants will receive HRS-1167. | Drug | HRS-1167 |
Primary outcome
Dose-limiting toxicity (DLT) of HRS-1167
Time frame: up to 24 days
Maximum tolerated dose (MTD) of HRS-1167
Time frame: up to 24 months
Recommended Phase II Dose (RP2D) of HRS-1167
Time frame: up to 24 months
AEs+SAEs
Time frame: up to 24 months
from the first drug administration to within 30 days for the last treatment dose
7 secondary outcomes
Evaluation of pharmacokinetic parameter of HRS-1167: Cmax
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: up to 24 months
Disease control rate (DCR)
Time frame: up to 24 months
Duration of response (DoR)
Time frame: up to 24 months
Progression Free Survival (PFS)
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Quanren Wang, M.D (+86 18036618570, quanren.wang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) of HRS-1167 (time frame: up to 24 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.