Phase III Study of RC148 Alone and in Combination to Treat Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating RC148, both alone and in combination with other therapies, in patients with locally advanced unresectable or metastatic malignant solid tumors. The study includes Phase I, which focuses on assessing safety, tolerability, and determining the maximum tolerated dose and recommended Phase II dose of RC148. Phase II primarily evaluates the effectiveness of RC148 in combination with other treatments, along with safety and pharmacokinetics, while also exploring biomarker correlations with treatment outcomes. Participants receive RC148 as an intravenous infusion either alone or combined with drugs such as docetaxel, RC48, RC88, or bevacizumab. Dosing schedules vary by treatment group, with infusions administered every 2 or 3 weeks depending on the combination. Phase I involves dose escalation with observation for dose-limiting toxicities over 28 days after the first treatment. Phase II includes multiple arms targeting different cancer types with specific combination therapies. Throughout the study, participants undergo regular assessments including monitoring for adverse events, physical exams, laboratory tests, and imaging to measure tumor response using RECIST criteria. Pharmacokinetic and pharmacodynamic evaluations, as well as immunogenicity tests, are conducted. The trial lasts up to 15 months, covering safety and efficacy outcomes. Researchers also collect tumor samples for biomarker analysis and monitor participants for long-term treatment effects and tolerability.

A Study of RC148 As a Single Agent and Combination Therapy in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors