An international, multicenter, open-label, Phase 1/2 clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of GenSci145, as monotherapy or in combination therapy, in participants with PIK3CA-mutated, locally advanced or metastatic solid tumors.
Ability to understand and voluntarily provide written ICF.
Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other protocol-specified procedures.
Age 18-75 years (inclusive) at the time of providing informed consent.
Histologically or cytologically confirmed locally advanced or metastatic solid tumors.
History of any active malignancy within ≤2 years prior to the first dose of GenSci145, except for the malignancy under investigation in this study and any curatively treated locally recurrent malignancies
Disease stable for at least 3 months, with no evidence of progression on imaging within 4 weeks prior to first dose of study treatment, all neurologic symptoms recovered to baseline, and no evidence of new or enlarging brain metastases.
At least 4 weeks have elapsed since completion of CNS-directed radiotherapy, surgery, or corticosteroid therapy prior to the first dose of study treatment.
History of leptomeningeal metastases, spinal cord compression, or leptomeningeal disease.