Evaluating Safety and Tolerability of CTX-10726 IV Infusion for Adults with Advanced or Metastatic Cancer in a Phase 1 Study

What this Trial Is About

Researchers are conducting a Phase 1, open-label study to evaluate CTX-10726 monotherapy in adults with metastatic or locally advanced cancers that are relapsed or refractory to standard treatments, or when no effective standard therapy exists. This first-in-human trial aims to assess the safety, tolerability, immune response, and how the body processes CTX-10726, while also observing preliminary anti-tumor effects. The study is sponsored by Compass Therapeutics and focuses on cancers including renal cell carcinoma, hepatocellular carcinoma, gastroesophageal cancer, and endometrial cancer. Participants will receive CTX-10726 through intravenous infusions given every two weeks. The study is divided into two parts a Dose Escalation Cohort where doses range from 0.3 to 10.0 mgkg to determine safe and tolerable levels, followed by a Dose Expansion Cohort that uses doses selected from the escalation phase. Treatments continue in cycles of two weeks, with infusions administered repeatedly based on the study design and patient response. Throughout the trial, participants will undergo safety monitoring for side effects, assessments of immune response, and tests measuring drug levels in the blood. Tumor responses will be evaluated using standard criteria, and disease progression and survival will be tracked for up to two years. Organ function tests, imaging, and other health evaluations will be performed regularly. Participants are followed closely to monitor treatment effects and safety from the first dose until after treatment ends.

A Phase 1 Study of the Safety and Tolerability of CTX-10726