A Phase 1/2 Study of Oncobax4-AK with Immunotherapy in Patients with Advanced Non-Small-Cell Lung and Renal Cell Carcinomas

What this Trial Is About

Researchers are evaluating the oral administration of Oncobax4-AK, a live bacterial product containing Akkermansia muciniphila, in patients with advanced non-small-cell lung carcinoma (NSCLC) or renal cell carcinoma (RCC). This phase 2 study explores whether restoring Akkermansia levels in the gut microbiota of patients deficient in this bacterium can improve the efficacy of immunotherapy. The presence of Akkermansia has been linked to better clinical responses in previous analyses, and preclinical models suggest Oncobax4-AK may help overcome resistance to immunotherapy. Participants receive Oncobax4-AK as one capsule daily until disease progression, excessive toxicity, or withdrawal of consent. The study includes two experimental groups for NSCLC and RCC patients, focusing on those whose gut microbiota lack Akkermansia as confirmed by stool PCR testing. Treatment is combined with ongoing immunotherapy, and the oral administration continues throughout the study period. During the study, participants undergo assessments including tumor response evaluation by iRECIST criteria and measurement of immunotherapy response rates over nine months. Researchers monitor progression-free survival and safety outcomes throughout. Participants must meet specific health criteria and provide informed consent, with ongoing monitoring for adverse events and compliance with protocol assessments. The study duration and follow-up align with the nine-month primary outcome evaluation.

A Study of Oncobax®-AK in Patients With Advanced Solid Tumors