A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy
A Phase 1b/2a Multi-Center, Dose Escalation and Reference Regimen-Controlled, Multi-Cohort Study to Determine the Safety and Efficacy of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy in Patients With Locally Advanced or Metastatic Cancers Following One or More Prior Therapies
Phase
PHASE1, PHASE2
Enrollment
126 (est.)
Age range
18 Years to —
Sex
ALL
Summary
An open-label Phase 1b dose escalation followed by a randomized Phase 2a comparison, evaluating oral alintegimod alone and combined with ipilimumab, followed by nivolumab monotherapy, in locally advanced or metastatic solid tumors.
Conditions studied
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Aug 23, 2024 – est. completion Dec 31, 2027
Sponsors
Study locations
University of Colorado Cancer Center
Aurora, Colorado
Florida Cancer Specialists
Lake Mary, Florida
Dartmouth Hitchcock
Lebanon, New Hampshire
Brown University Health Cancer Institute
Providence, Rhode Island
MD Anderson Cancer Center
Houston, Texas