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

NCT06362369 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2026-04-13

No results posted yet for this study

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

Conditions

Interventions

DRUG

Alintegimod

Alintegimod will be provided in bottles of 30 softgel capsules for oral administration

DRUG

Ipilimumab

Ipilimumab (Yervoy) will be administered via IV

DRUG

Nivolumab

Nivolumab (Opdivo) will be administered via IV

Sponsors & Collaborators

  • 7 Hills Pharma, LLC

    lead INDUSTRY

Principal Investigators

  • Lionel Lewis, MA, MB.Bch, MD · 7 Hills Pharma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-23
Primary Completion
2027-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06362369 on ClinicalTrials.gov