Phase I Study of SPGL008 Treatment for Adults With Advanced Malignant Tumors Evaluating Safety and Early Effects via Intravenous and Subcutaneous Methods

What this Trial Is About

Researchers are evaluating SPGL008, a biological product, for its safety, tolerability, and early effectiveness in patients with advanced malignant tumors. This phase I study involves two groups to assess intravenous and subcutaneous administration methods. The study uses a dose-escalation design to carefully examine how different doses affect patients. There are two main groups in the study one receives SPGL008 through intravenous infusions, and the other through subcutaneous injections. Both groups undergo dose escalation, starting from lower doses and increasing to higher ones to find the safest and most tolerable dose levels. The treatment cycles last 21 days, during which safety and tolerability are closely monitored. Participants will be observed for dose-limiting toxicities and the maximum tolerated dose during the first 21-day cycle. Researchers will also measure responses to treatment, drug concentration levels, and how the drug is processed in the body over up to two years. Throughout the study, patients will have regular assessments including laboratory tests and monitoring to track safety and treatment effects. The total participation time may extend up to two years depending on outcomes.

A Phase I Study of SPGL008 in Subjects With Advanced Malignant Tumors