drugset / Trial / NCT06362369

A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy

NCT06362369 ↗

Phase 1/2 Recruiting 126 enrolled 7 Hills Pharma, LLC
NaSequentialOpen-labelTreatment

Summary

This study is an open-label Phase Ib (Part A) dose escalation followed by a blinded, randomized, multi cohort Phase 2a (Part B) comparison of combination vs. reference regimens. Currently study will only be enrolling the Phase 1b and the Phase 2a protocol requirements will be added to the study near completion of the Phase 1b

Timeline

Start
2024-08-23
Primary completion
2027-12-31
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Alintegimod Small molecule — Oral
Subject Ipilimumab Monoclonal antibody — Intravenous
Subject Nivolumab Monoclonal antibody — Intravenous