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
7 Hills Pharma, LLC
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
Description
This Phase study is designed to evaluate the safety, tolerability, and preliminary efficacy of oral Alintegimod (Alintegimod) alone, and then in combination with ipilimumab for, followed by nivolumab monotherapy cycles. All patients will receive nivolumab after completion of treatment with Alintegimod plus ipilimumab combination therapy to continue nivolumab treatment until the end of study (12 months) unless progression or toxicity result in early termination.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion and Exclusion Criteria for Phase 1b Inclusion Criteria 1. Adult patients (age 18 or older) 2. 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 wit…
Interventions
- DrugAlintegimod
Alintegimod will be provided in bottles of 30 softgel capsules for oral administration
- DrugIpilimumab
Ipilimumab (Yervoy) will be administered via IV
- DrugNivolumab
Nivolumab (Opdivo) will be administered via IV
Locations (5)
- University of Colorado Cancer CenterAurora, Colorado
- Florida Cancer SpecialistsLake Mary, Florida
- Dartmouth HitchcockLebanon, New Hampshire
- Brown University Health Cancer InstituteProvidence, Rhode Island
- MD Anderson Cancer CenterHouston, Texas