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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
7 Hills Pharma, LLC
Study ID
NCT06362369
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Alintegimod — DRUG
    Alintegimod will be provided in bottles of 30 softgel capsules for oral administration
  • Ipilimumab — DRUG
    Ipilimumab (Yervoy) will be administered via IV
  • Nivolumab — DRUG
    Nivolumab (Opdivo) will be administered via IV

Study Details

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

Key Dates

Start date
Aug 23, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
126 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation - Open Label Phase 1b
    Alintegimod dose escalation, 4 cohorts Alintegimod monotherapy 1 cycle Alintegimod + Ipilimumab - 4 cycles Nivolumab - 11 cycles

Primary Outcome Measure

Number of participants treated with Alintegimod monotherapy with treatment related adverse events as assessed by CTCAEv5.0 [ Time Frame: 1 year ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of Colorado Cancer CenterAuroraColorado84005
Kathy P Clinical Research Coordinator IV
[email protected]
303.724.9815
Sapna Patel, MD (PRINCIPAL_INVESTIGATOR)
Florida Cancer SpecialistsLake MaryFlorida32746-
Dartmouth HitchcockLebanonNew Hampshire03756
Study Coordinator
603.650.6345
Konstantin H Dragnev, MD (PRINCIPAL_INVESTIGATOR)
Brown University Health Cancer InstituteProvidenceRhode Island02906
Cancer Institutre Clinical Research Nurse
[email protected]
312-583-8700
MD Anderson Cancer CenterHoustonTexas77030
Study Coordinator
713.792.4259
Apostolia-Maria Tsimberidou, MD, PhD (PRINCIPAL_INVESTIGATOR)

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