This study is an open-label, multicenter, Phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of JS105 in combination with other anti-tumor therapies in patients with advanced solid tumors. Patients will be enrolled in two stages: a dose-escalation stage and a dose-expansion stage.
Understand and voluntarily sign the informed consent form;
18≤ age ≤ 75 years old, male or female;
Patients with histologically or cytologically confirmed recurrent/metastatic HR-positive and HER2-negative breast cancer;
HER2 negative must meet one of the following: IHC 0, IHC 1+; IHC2+ should be further confirmed by in situ hybridization (ISH) to determine HER2 negative, and different tissue blocks can also be selected for re-testing;
At least one measurable lesion (only for Phase II cohort expansion phase) or non-measurable osteolytic or mixed bone lesion (for breast cancer patients only) that meets the requirements of RECIST v1.1;
Eastern Cooperative Oncology (ECOG) performance status score: 0 or 1;
Expected survival ≥ 12 weeks;
Ability to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening, or otherwise altering the dosage form of the product;
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Treatment groupsSee each treatment group below.