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

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

Trial Details

NCT ID
NCT06362369
Phase
PHASE1 / PHASE2
Sponsor
7 Hills Pharma, LLC
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Alintegimod
  • Ipilimumab
  • Nivolumab
Locations (sample)
  • Aurora, Colorado, United States|39.72943,-104.83192
  • Lake Mary, Florida, United States|28.75888,-81.31784
  • Lebanon, New Hampshire, United States|43.64229,-72.25176
  • Providence, Rhode Island, United States|41.82399,-71.41283
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • Inclusion Criteria
  • Adult patients (age 18 or older)
  • Patient has a histologically confirmed diagnosis of any of the following locally advanced or metastatic solid tumors: melanoma, pleural mesotheliom…
  • ANC ≥ 1000/µL without use of G-CSF, Hgb ≥ 9 g/dL without required blood transfusion for at least 5 days prior to pretreatment baseline, and platele…

For full eligibility, visit ClinicalTrials.gov.

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