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Recruiting Phase 1 NCT05473624

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

Trial Parameters

Condition Advanced Solid Tumors
Sponsor Jiangsu HengRui Medicine Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 153
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-08-23
Completion 2026-12-31
Interventions
HRS-1167

Brief 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 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.

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