A Phase I Study of RGT-419B in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer or Other Solid Tumors
This is a Phase 1 dose escalation and dose expansion phase I study to evaluate the safety, tolerability, pharmacokinetic profile and preliminary efficacy of RGT-419B as monotherapy in Chinese patients with HR+/HER2- advanced/metastatic breast cancer and other advanced solid tumors.
- EligibilityCriteria: Inclusion Criteria:  Male or female ≥ 18 years of age Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Subjects with pathologically confirmed advanced solid tumors who have failed standard-of-care therapy, or have no standard-of-care therapy available, or are currently not eligible for standard-of-care therapy; Subjects with HR+/ HER2- advanced or metastatic breast cancer are preferred. Estimated life expectancy of at least 12 weeks  Exclusion Criteria:  Presence of visceral metastases with severe organ dysfunction Known active hepatitis B or C infection Prior irradiation to >25% of the bone marrow and/or inadequate bone marrow function or evidence of clinicallysignificant end-organ damage History of allergic reactions attributed to compounds of similar chemical or biologic composition to the drugs usedin the study - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult