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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
Sponsor7 Hills Pharma, LLC

About this trial

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

Eligibility criteria

Qualifiers

None

Disqualifiers

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 mesothelioma, renal cell carcinoma, MSI-high or mismatch repair-deficient colorectal cancer, hepatocellular carcinoma, and non-small cell lung cancer with no EGFR or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, or tumor types for which the combination of ipilimumab and nivolumab has been FDA approved. Patients may have received treatment with anti PD-1/PD-L1.

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 platelet count ≥ 75,000/µL without transfusions for at least 5 days prior to pretreatment baseline.

ECOG performance status of 0 or 1.

Trial design

Treatments tested in this trial

  • Alintegimod
  • Ipilimumab
  • Nivolumab

Treatment groups

126 Participants
are divided into 1 treatment group

Locations

5
University of Colorado Cancer Center84005, AuroraColorado, United States
Florida Cancer Specialists32746, Lake MaryFlorida, United States
Dartmouth Hitchcock03756, LebanonNew Hampshire, United States
Brown University Health Cancer Institute02906, ProvidenceRhode Island, United States

Sponsors and collaborators

7 Hills Pharma, LLC

Lead sponsor