Trial Parameters
Brief Summary
This is a Phase 1, first-in-human (FIH), open-label, multicenter, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of XKH002 in patients with advanced or metastatic solid tumors.
Eligibility Criteria
Inclusion Criteria: 1. Age 18 years or older; 2. Life expectancy at least 3 months. 3. Histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumor. Patient has had disease progression on one or more standard treatment regimens, or could not tolerate the treatment, or has no available treatment options. 4 The physical status score of "Eastern Cancer Collaboration Group (ECOG)" (see Appendix 5) was 0-1; 5 According to RECIST v1.1, all patients must have at least one evaluable lesion at baseline. 6 For patients with stable BMS, all of the following criteria must be met: * At least 28 days after receiving specialist treatment for central nervous system disorders and at least 14 days after the last corticosteroid treatment. * Clinical symptoms were stable after the last treatment: no new central nervous system metastases or radiotherapy complications. Note: Patients who developed new progressive clinical symptoms or spinal cord compression or pIA diseas