Study of HRS-1167 as Monotherapy in Patients With Advanced Solid Tumors

Last updated: April 11, 2025
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

HRS-1167

Clinical Study ID

NCT05473624
HRS-1167-I-101
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 solidmalignancies who are refractory to standard therapies or for which no standardtherapy exists;

  5. Efficacy expansion part:Ovarian Cancer、Breast Cancer、Pancreatic Cancer、ProstateCancer 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

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.

Study Design

Total Participants: 153
Treatment Group(s): 1
Primary Treatment: HRS-1167
Phase: 1
Study Start date:
August 23, 2022
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing 100021
    China

    Active - Recruiting

  • Chongqing Cancer Hospital

    Chongqing, Chongqing 400030
    China

    Active - Recruiting

  • Guangxi Medical University Affiliated Tumor Hosipital

    Nanning, Guangxi 530021
    China

    Active - Recruiting

  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

    Guangzhou, Guangzhou 510120
    China

    Active - Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150081
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan 450008
    China

    Active - Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan 410013
    China

    Active - Recruiting

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jiangsu 210029
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330209
    China

    Active - Recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Active - Recruiting

  • Liaoning Cancer Hospital

    Shenyang, Liaoning 110042
    China

    Active - Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning 110001
    China

    Active - Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shangdong 250062
    China

    Active - Recruiting

  • Shandong Cancer Hospital

    Jinan, Shangdong 250117
    China

    Active - Recruiting

  • Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi 030001
    China

    Active - Recruiting

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi 030013
    China

    Active - Recruiting

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan 646099
    China

    Active - Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin 300060
    China

    Active - Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhengjiang 310022
    China

    Active - Recruiting

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