A Phase I Clinical Study of Recombinant Humanized Monoclonal Antibody MIL95 Injection in the Treatment of Lymphomas and Advanced Malignant Solid Tumors

What this Trial Is About

Researchers are evaluating the recombinant humanized monoclonal antibody MIL95 in adults with refractory or relapsed lymphomas and advanced malignant solid tumors. This Phase I clinical trial uses a classical 3+3 dose escalation design in two parts: Part A focuses on initial dose escalation, and Part B on maintenance dose escalation. The study aims to assess safety and adverse events, along with pharmacokinetics, response rates, and immunogenicity over up to one year after enrollment. In Part A, participants receive weekly intravenous infusions of MIL95 at increasing doses starting from 0.1 mg/kg, progressing through 0.3 mg/kg, 0.8 mg/kg, and 1 mg/kg for up to twelve weeks. In Part B, a recommended priming dose from Part A is followed by maintenance doses at higher levels (3 mg/kg to 45 mg/kg) given on specific days across 28-day cycles. Dose limiting toxicity is monitored for 14 days in Part A and 28 days in Part B, with cohort sizes adjusted based on enrollment. Participants will undergo regular assessments including monitoring for adverse events, pharmacokinetic blood tests, and evaluation of tumor response using established criteria. Safety follow-up will continue for up to one year. The study collects data on progression-free survival and duration of response, with participants expected to comply with the treatment schedule and study protocol throughout the trial duration.

A Clinical Study of MIL95 in Advanced Malignancies.