Anwita Biosciences
This study is aimed at establishing the MTD and/or the RP2D for AWT020 monotherapy and to provide safety, tolerability, efficacy, PK, immunogenicity characteristics of AWT020.
This study will enroll participants who have undergone at least one systemic therapy and have progressive disease during or after most recent line of therapy, and for whom no further standard therapy (that is known to confer clinical benefit) is available, or who are intolerant of standard therapy. The study design consists of two parts: dose escalation (BOIN design) and dose optimization. Participants enrolled into this study will be assigned to one of 4 dose levels and will receive AWT020 via intravenous infusion at a regular interval. The treatment will be continued until disease progressio…
Inclusion Criteria: * Age 18 years or older; able to provide written informed consent and comply with study visits and procedures. * Pathologically confirmed, unresectable advanced solid tumor. * Disease progression after at least one systemic therapy, with no beneficial standard option available or tolerated. Disease-specific prior therapy requirements apply to urothelial and renal cell carcinoma cohorts. * At least one measurable lesion by RECIST version 1.1, ECOG performance status of 0 or 1, and life expectancy of at least 3 months. * Adequate bone marrow, renal, hepatic, coagulation, and…
Participants receiving AWT020 once every three weeks at designated dose levels
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