Phase 12 Study of INBRX-106 Alone or With Pembrolizumab for Adults With Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating the safety and proper dosing of INBRX-106, a hexavalent OX40 agonist antibody, alone or combined with pembrolizumab Keytruda in adults with locally advanced or metastatic solid tumors. This Phase 12, open-label, non-randomized study aims to find the maximum tolerated dose and recommended Phase 2 dose of INBRX-106 while monitoring its effects in various solid tumor types, including non-small cell lung cancer, melanoma, head and neck cancer, renal cell carcinoma, urothelial carcinoma, and others. Participants receive INBRX-106 either alone or in combination with pembrolizumab, with some groups also receiving chemotherapy drugs like carboplatin, pemetrexed, cisplatin, paclitaxel, nab-paclitaxel, or gemcitabine. Treatments are given through intravenous infusions in cycles typically lasting 3 weeks, with some dosing schedules alternating every 6 weeks or involving priming doses. The study includes multiple parts and cohorts focusing on different tumor types, treatment combinations, and disease stages, such as neoadjuvant and adjuvant therapies for resectable non-small cell lung cancer. During the study, participants undergo regular clinical assessments to monitor safety, including tracking adverse events and determining dose tolerance, as well as evaluating antitumor activity. Blood samples are collected for drug levels and immune response measurements over about two years. Participants may have imaging and other tests as needed, and safety monitoring continues throughout treatment. The study lasts until July 2033, with ongoing evaluations of how participants respond and tolerate the treatments administered.

Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)