Phase I Study Evaluating Safety and Effects of AWT020 Alone or With Other Cancer Treatments in Adults with Advanced Cancers

What this Trial Is About

Researchers are evaluating the safety and tolerability of AWT020 alone and in combination with other antitumor therapies in patients with advanced cancers such as non-small cell lung cancer, colorectal cancer, renal cell carcinoma, melanoma, and other solid tumors. This phase I clinical study aims to assess these treatments in patients who have failed or are intolerant to standard therapies or have no standard treatment options. The study also explores pharmacokinetics and efficacy outcomes. Participants receive AWT020 either alone or combined with drugs including Taxol, Cisplatin or Carboplatin, Pemetrexed, Oxaliplatin, Capecitabine, Bevacizumab, or Renvastinib. Dosing schedules vary by drug, for example, Taxol is given every three weeks at 135-175 mgm, while AWT020 is administered intravenously every two or three weeks. The study includes single-agent dose escalation and expansion phases, as well as combination treatment phases, tailored to specific cancer types and prior treatment histories. During the study, participants undergo regular monitoring for dose-limiting toxicities, adverse events, and serious adverse events for up to 12 months. Pharmacokinetics and immunogenicity are evaluated for up to 24 months, while response rates, duration of response, disease control, progression-free survival, and overall survival are assessed up to approximately 32 months. Patients have scheduled visits for treatment administration and safety assessments, with adherence to contraception requirements for fertile participants. The total study duration extends until April 2028.

A Clinical Study to Evaluate the Safety and Tolerability of AWT020 in Patients With Advanced Malignancies