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

RECRUITINGPhase 1Sponsored by Jiangsu HengRui Medicine Co., Ltd.
Actively Recruiting
PhasePhase 1
SponsorJiangsu HengRui Medicine Co., Ltd.
Started2022-08-23
Est. completion2026-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions2

Advanced Solid TumorsCancer

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