Clinical trial Recruiting at 20 sites Phase 1 Interventional Ages 18 and up

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

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment153 (estimated)
SponsorJiangsu HengRui Medicine Co., Ltd.
Industry-sponsored
Drugs / interventionschemotherapy
Locations20 sites (Beijing, Beijing Municipality and 19 other locations)
StatusRecruiting
StartedAugust 23, 2022
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedApril 15, 2025
Trial IDNCT05473624 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • CG-7321: a first-in-human test in advanced solid tumors

    We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.

    Recruiting at 4 sites Phase 1 Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. · Fuzhou, Fujian and 3 other locations · NCT07923214

  • AK157D1 injection for advanced solid tumors

    A first-in-human Phase 1 study tests AK157D1 injection in adults with unresectable advanced solid tumors to see if it is safe and tolerable and to get early signs of how it behaves in the body and against tumors.

    Recruiting Phase 1 Akeso · Harbin, Heilongjiang and 2 other locations · NCT07847281

  • ABBV-253 in adults with advanced solid tumors

    This study tests ABBV-253 to see if it is safe, how it affects the cancer, and how the drug moves in the body for adults with advanced solid tumors.

    Recruiting at 3 sites Phase 1 AbbVie · Grand Rapids, Michigan and 2 other locations · NCT07807956

  • 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.

    Recruiting at 7 sites Phase 2 Merck Sharp & Dohme LLC · Belleville, New Jersey and 6 other locations · NCT07793942

  • 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.

    Recruiting Zhejiang Hospital · Hangzhou, Zhejiang · NCT07793214

  • MK-2010 with Sac-TMT in advanced solid tumors

    This study tests MK-2010 combined with sacituzumab tirumotecan (sac-TMT) to see if it can help people with advanced solid tumors.

    Recruiting at 4 sites Phase 2 Merck Sharp & Dohme LLC · San Antonio, Texas and 3 other locations · NCT07785609

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.