A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors

Who cannot join

• Prior treatment with PI3K/AKT/mTOR inhibitors, prior treatment with fulvestrant and other SERDs (applicable to phase II of group A and phase II of group B);
• Patients with known hypersensitivity to JS105 and/or the corresponding group of combination drug components;
• Received the following treatments before the first dose of the study drug:
• 1) Major surgery or radiotherapy within 4 weeks, or anticipated major surgery (except tumor biopsy) or radiotherapy during the study; 2) Systemic chemotherapy within 4 weeks (6 weeks for nitrosourea or mitomycin; oral fluorouracil can be shortened to 2 weeks or 5 half-lives of the drug, whichever is longer), targeted therapy (small molecule targeted drugs can be shortened to 2 weeks or 5 half-lives of the drug, whichever is longer), immunotherapy or biological therapy; 3) Receiving endocrine therapy or proprietary Chinese medicine preparations with anti-tumor indications within 2 weeks.
• 4) Other clinical investigational drugs (without placebo) within 4 weeks; 5) Vaccination with live attenuated vaccine within 4 weeks; 6) Received drug treatment with a known strong inhibitor or inducer of the isoenzyme CYP3A4 within 7 days (see Appendix 4 for a strong inhibitor or inducer of the isoenzyme CYP3A4); 7) Need for long-term use or use of ≥10mg/day prednisone and equivalent doses of systemic corticosteroids or immunosuppressive drugs within 2 weeks before the first dose; 4. Previous allogeneic bone marrow transplantation or solid organ transplantation; 5. Other malignancies other than study disease within 5 years before the first dose, except for malignancies that can be expected to heal after treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with radical surgery); 6. Patients with symptomatic, untreated, or ongoing central nervous system metastases requiring ongoing treatment (previously treated patients who have been stable for at least 3 months, have no disease progression as determined by imaging within 4 weeks before the first dose of the study, and all neurological symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and have stopped using radiation, surgery, or steroids at least 4 weeks before the first dose of study treatment, may be enrolled); 7. Pleural effusion, pericardial effusion, or ascites effusion (once a month or more frequent) that is uncontrolled or requires repeated drainage. Patients who need to be stable for at least 1 week before enrollment after drainage can be enrolled (stable is defined as no clear increase in pleural effusion without any intervention); 8. Concomitant and uncontrollable concomitant diseases, including but not limited to:
• History of acute pancreatitis, history of chronic pancreatitis, or presence of pancreatic metastases within one year before screening;