RecruitingPhase 1Phase 2NCT06362369

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


Sponsor

7 Hills Pharma, LLC

Enrollment

126 participants

Start Date

Aug 23, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a new oral drug called alintegimod (7HP349) to a standard immunotherapy combination (ipilimumab and nivolumab) can improve outcomes for people with advanced solid tumors like melanoma, lung cancer, liver cancer, and others. **You may be eligible if...** - You are 18 or older - You have a confirmed advanced or metastatic solid tumor (including melanoma, kidney cancer, liver cancer, mesothelioma, certain colon cancers, or lung cancer without certain genetic mutations) - Your cancer has returned or progressed despite prior treatment - You are in good enough physical condition to tolerate treatment (ECOG performance status 0 or 1) - You have adequate kidney, liver, and blood function - Your life expectancy is more than 12 weeks **You may NOT be eligible if...** - You have serious unresolved side effects from prior cancer treatment - You have active autoimmune conditions requiring systemic treatment - You are pregnant or unwilling to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Center

Aurora, Colorado, United States

Florida Cancer Specialists

Lake Mary, Florida, United States

Dartmouth Hitchcock

Lebanon, New Hampshire, United States

Brown University Health Cancer Institute

Providence, Rhode Island, United States

MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06362369


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