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

NCT ID: NCT05473624

Last Updated: 2025-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-23

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HRS-1167

Group Type EXPERIMENTAL

HRS-1167

Intervention Type DRUG

Participants will receive HRS-1167.

Interventions

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HRS-1167

Participants will receive HRS-1167.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Guangxi Medical University Affiliated Tumor Hosipital

Nanning, Guangxi, China

Site Status RECRUITING

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

Guangzhou, Guangzhou, China

Site Status RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Site Status RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

Site Status RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

Site Status RECRUITING

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Site Status RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, China

Site Status RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status RECRUITING

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Site Status RECRUITING

Qilu Hospital of Shandong University

Jinan, Shangdong, China

Site Status RECRUITING

Shandong Cancer Hospital

Jinan, Shangdong, China

Site Status RECRUITING

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Site Status RECRUITING

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, China

Site Status RECRUITING

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

Site Status RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhengjiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Quanren Wang, M.D

Role: CONTACT

+86 18036618570

Facility Contacts

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Lingying Wu, Doctor

Role: primary

+86-010-87788996

Other Identifiers

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HRS-1167-I-101

Identifier Type: -

Identifier Source: org_study_id

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