This study will evaluate the safety, of SIM0689 and how the body processes it, how it affects the body, and its early signs of activity against tumors when given alone to Adult Participants with Locally Advanced or Metastatic Solid Tumors. The study has a dose escalation part to find the highest dose that can be given safely, or recommended dose (RD) for SIM0689 when given alone, and a dose expansion part in subjects with specific tumor types treated with SIM0689 as a single agent at RD.
In dose-escalation cohorts (Part 1), histologically or cytologically documented advanced or metastatic solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject refuses standard therapy.
In the dose-expansion cohorts (Part 2), histologically or cytologically confirmed selected advanced solid tumors.
Subjects must have at least one measurable lesion according to RECIST Version1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
Symptomatic brain metastases.
Serious non-healing wounds, ulcers or fractures.
Toxicity from previous treatment has to restore to ≤ grade 1.
Major surgery (excluding biopsy) or significant trauma within 4 weeks prior to enrollment.
Jiangsu Simcere Pharmaceutical Co., Ltd.
Lead sponsor
Shanghai Xianwei Medical Technology Co., Ltd.
Collaborator