A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy
Public ClinicalTrials.gov record NCT06362369. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT06362369
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Lead sponsor
- 7 Hills Pharma, LLC
- Industry
- Enrollment
- 126 participants
Conditions and interventions
Conditions
- ALK Genomic Tumor Aberrations
- Advanced Cancer
- Advanced Solid Tumor
- Anaplastic Lymphoma Kinase Genomic Tumor Aberrations
- Colorectal Cancer
- Hepatocellular Cancer
- Hepatocellular Carcinoma
- Kidney Cancer
- MSI-High
- Melanoma
- Metastasis
- Mismatch Repair Deficiency
- NSCLC
- Non Small Cell Lung Cancer
- Pleural Mesothelioma
- Renal Cell Cancer
- Renal Cell Carcinoma
- Skin Cancer
Interventions
- Alintegimod Drug
- Ipilimumab Drug
- Nivolumab Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 22, 2024
- Primary completion
- Dec 30, 2027
- Completion
- Dec 30, 2028
- Last update posted
- Apr 12, 2026
2024 – 2028
United States locations
- U.S. sites
- 5
- U.S. states
- 5
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Colorado Cancer Center | Aurora | Colorado | 84005 | Recruiting |
| Florida Cancer Specialists | Lake Mary | Florida | 32746 | Completed |
| Dartmouth Hitchcock | Lebanon | New Hampshire | 03756 | Recruiting |
| Brown University Health Cancer Institute | Providence | Rhode Island | 02906 | Recruiting |
| MD Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06362369, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 12, 2026 · Synced May 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06362369 live on ClinicalTrials.gov.