Testing HRS-1167 for advanced solid tumors

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 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
• Enrollment: 153 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 20 sites (Beijing, Beijing Municipality and 19 other locations)
• Trial ID: NCT05473624 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: While this approach is being explored in this specific context, similar studies have shown promise in evaluating novel treatments for advanced solid tumors.

Eligibility 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 this trial is running

Beijing, Beijing Municipality and 19 other locations

• 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)
• 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

Conditions Advanced Solid Tumors