Testing HRS-1167 for advanced solid tumors
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
Run by Jiangsu HengRui Medicine Co., Ltd. · NCT05473624 · Data updated 2026-11-12
This study is testing a new drug called HRS-1167 to see if it can help people with advanced solid tumors, like ovarian, breast, pancreatic, and prostate cancers, who haven't had success with other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 153 (estimated) |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 20 sites (Beijing, Beijing Municipality and 19 other locations) |
| Status | Recruiting |
| Started | August 23, 2022 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | April 15, 2025 |
| Trial ID | NCT05473624 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with advanced solid tumors that are refractory to standard therapies or have no available standard treatment.
✕Probably not a fit
Patients with untreated or uncontrolled brain metastases or those who have undergone recent surgery or chemotherapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the safety, tolerability, and anti-cancer activity of HRS-1167 as a standalone treatment for patients with advanced solid tumors. It includes a dose escalation phase and an efficacy expansion phase focusing on specific cancer types such as ovarian, breast, pancreatic, and prostate cancers with HRR gene mutations. Participants must have advanced malignancies that are resistant to standard therapies or for which no standard treatment exists. The study aims to gather data on the drug's effectiveness and side effects in this patient population.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment choices.
How similar studies have gone: While this approach is being explored in this specific context, similar studies have shown promise in evaluating novel treatments for advanced solid tumors.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China Recruiting -
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China Recruiting -
Guangxi Medical University Affiliated Tumor Hosipital
Nanning, Guangxi, China Recruiting -
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangzhou, China Recruiting -
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China Recruiting -
Henan Cancer Hospital
Zhengzhou, Henan, China Recruiting
Show 14 more locations
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Hunan Cancer Hospital
Changsha, Hunan, China Recruiting -
Hunan Cancer Hospital
Changsha, Hunan, China Recruiting -
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China Recruiting -
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China Recruiting -
The First Hospital of Jilin University
Changchun, Jilin, China Recruiting -
The First Hospital of China Medical University
Shenyang, Liaoning, China Recruiting -
Liaoning Cancer Hospital
Shenyang, Liaoning, China Recruiting -
Qilu Hospital of Shandong University
Jinan, Shangdong, China Recruiting -
Shandong Cancer Hospital
Jinan, Shangdong, China Recruiting -
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China Recruiting -
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China Recruiting -
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China Recruiting -
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China Recruiting -
Zhejiang Cancer Hospital
Hangzhou, Zhengjiang, China Recruiting
Study contacts
- Study coordinator: Quanren Wang, M.D
- Email: quanren.wang@hengrui.com
- Phone: +86 18036618570
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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CG-7321: a first-in-human test in advanced solid tumors
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-
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ABBV-253 in adults with advanced solid tumors
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MK-2010 alone or with other treatments for advanced solid tumors
This trial tests MK-2010, by itself or with other cancer medicines, to see if it helps people with advanced solid tumors.
-
Whole-Body Infrared Heating for Advanced Solid Tumors
This study looks at how ET-SPACE whole-body infrared hyperthermia affects people with advanced solid tumors to see if it changes biology, symptoms, and safety.
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MK-2010 with Sac-TMT in advanced solid tumors
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.