Brief Summary
This is a multicenter, open-label, Phase 1 study. The study will enroll subjects with advancedat a late stage, far along solid tumors. It consists of three parts. Part 1 is dose-escalation part. In part 1, the safety and tolerability of YL211 in patients with selected advanced solid tumors will be evaluated and the MTD and RED will be determined.
Part 2 is backfill enrollment part. We will further estimate the safety and efficacy of YL211 in patients with selected adcance tumor to select the RED(s) of YL211.
Part 3 is dose-expansion part. In this part, we will further evaluate the safety and efficacy of YL211 at the MTD/RED(s) in patients with selected advanced solid tumors YL211 will be administered intravenously (IV) until criteria of treatment discontinuation are met.
Intervention / Treatment
- Drug: YL211
Inclusion Criteria:
- Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF.
- Aged ≥18 years.
- Be able and willing to comply with protocol visits and procedures.
- History of an advanced solid tumors who failed currently available standard therapies and are not amenable to surgical resectionsurgical removal of tissue or part/all of an organ, or for whom no available standard therapy or no other approved therapeutic options that have demonstrated clinical benefit.
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group performance status (ECOG PS) of 0 or 1.
- Adequate organ and bone marrowsoft, spongy tissue found in bones that makes blood cells function.
- Have at least 1 extracranial measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.