RecruitingPhase 1NCT05473624
Study of HRS-1167 as Monotherapy in Patients With 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
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Enrollment
153 participants
Start Date
Aug 23, 2022
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria7
- Age ≥ 18；
- ECOG performance status 0-1;
- Life expectancy is not less than 12 weeks;
- 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；
- Efficacy expansion part：Ovarian Cancer、Breast Cancer、Pancreatic Cancer、Prostate Cancer or other cancer types with HRR gene mutation；
- At least one target lesion (except maintenance therapy);
- Adequate organ and marrow function as defined by the protocol.
Exclusion Criteria4
- Surgery or chemotherapy within 4 weeks of the first dose of study treatment；
- Subjects that are unable to swallow, or dysfunction of gastrointestinal absorption；
- Active HBV/HCV/HIV infection;
- Untreated and/or uncontrolled brain metastases.
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Interventions
DRUGHRS-1167
Participants will receive HRS-1167.
Locations(20)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05473624
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