Trials / Recruiting
RecruitingNCT06362369
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
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 126 (estimated)
- Sponsor
- 7 Hills Pharma, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Detailed 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.
Conditions
- Advanced Cancer
- Advanced Solid Tumor
- Melanoma
- Metastasis
- Pleural Mesothelioma
- Renal Cell Carcinoma
- MSI-High
- Mismatch Repair Deficiency
- Colorectal Cancer
- Hepatocellular Carcinoma
- Hepatocellular Cancer
- Renal Cell Cancer
- Kidney Cancer
- Skin Cancer
- Non Small Cell Lung Cancer
- NSCLC
- Anaplastic Lymphoma Kinase Genomic Tumor Aberrations
- ALK Genomic Tumor Aberrations
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2024-08-23
- Primary completion
- 2027-12-31
- Completion
- 2028-12-31
- First posted
- 2024-04-12
- Last updated
- 2026-04-13
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06362369. Inclusion in this directory is not an endorsement.