Phase 1 Study of CRD3874-SI, a STING Agonist, for Adults with Advanced or Metastatic Solid Tumors including Sarcoma and Merkel Cell Carcinoma

What this Trial Is About

Researchers are evaluating the safety and effects of a study drug called CRD3874-SI in adults with advanced or metastatic malignant solid tumors, including types such as sarcoma, Merkel Cell Carcinoma, head and neck squamous cell carcinoma, adenoid cystic carcinoma, uveal melanoma, mucosal and acral melanoma, and non-small cell lung cancer. The study aims to find the highest dose of CRD3874-SI that causes only mild or manageable side effects and to learn more about how the drug is processed by the body and how the immune system responds to it. Participants receive weekly intravenous infusions of CRD3874-SI starting at a dose of 0.1 mgkg, with dose levels increasing in phases to find the recommended dose for further study. The treatment cycles vary, with the first two cycles consisting of four weekly infusions each over 28 days, and later cycles providing three weekly infusions if the treatment is well tolerated. The trial also includes a dose expansion phase where the recommended dose and one additional active dose are tested in selected tumor types. Blood tests and tumor biopsies are performed during the study to help assess the drugs effects. During the trial, participants undergo regular evaluations including tumor biopsies when feasible, blood tests for immune cells, and assessments of tumor response. Safety is closely monitored through side effect tracking and organ function tests. The studys main outcomes include determining the maximum tolerated dose over one year and measuring tumor response rates during dose expansion up to 48 weeks. Participation may last several months depending on treatment tolerance and disease progression, with ongoing monitoring to understand the drugs safety and activity.

A Study of CRD3874-SI in People With Solid Tumors