Oral Alintegimod (7HP349) Trial Adds Mesothelioma to Its Cohorts

A clinical trial run by 7 Hills Pharma is testing an oral drug called alintegimod (7HP349) in people with advanced solid tumors, and pleural mesothelioma is one of the cancer types it accepts. The study pairs the experimental pill with two established immunotherapy drugs to see whether the combination is safe and what dose to carry forward.

The trial, listed on ClinicalTrials.gov as NCT06362369, is a Phase 1b/2a study. It started in August 2024 and is currently recruiting. The investigational agent here is alintegimod, not the checkpoint inhibitors it is combined with, so this study sits apart from the many mesothelioma trials that test nivolumab and ipilimumab on their own.

What the Trial Is Testing

The drug under investigation is alintegimod, also known by its development code 7HP349. According to its developer, 7 Hills Pharma, it is an orally delivered small molecule that activates the integrins LFA-1 and VLA-4 to augment antigen-specific immune responses. A peer-reviewed 2021 paper in npj Vaccines describes 7HP349 as a small molecule allosteric activator of the integrin cell adhesion molecules αLβ2 (LFA-1) and α4β1 (VLA-4). In plain terms, the drug is meant to strengthen the cell-to-cell contacts that immune cells use to recognize and respond to a tumor.

In this trial, alintegimod is given as softgel capsules taken by mouth. The two other drugs are familiar checkpoint inhibitors delivered by IV: ipilimumab (Yervoy), a CTLA-4 inhibitor, and nivolumab (Opdivo), a PD-1 inhibitor.

The study has a single experimental arm during the part now enrolling, a dose-escalation phase. The record describes the schedule this way: participants receive alintegimod alone for one cycle, then alintegimod combined with ipilimumab for four cycles, followed by nivolumab for eleven cycles. The dose-escalation phase moves through four cohorts to work out how much alintegimod people can tolerate.

What the Study Measures

This is an early-phase study, so its main goals are about safety and dose, not proof of benefit. The primary outcome measures listed on ClinicalTrials.gov are:

• Treatment-related adverse events with alintegimod given alone, graded by CTCAE v5.0
• Treatment-related adverse events with alintegimod given in combination, graded by CTCAE v5.0
• The recommended Phase 2 doses to carry forward

The secondary outcome measures include pharmacokinetic parameters such as Cmax and AUC, plus progression-free survival and overall response rate measured by RECIST v1.1. The trial record does not report results for any of these measures.

Which Cancers Are Eligible

The trial accepts adults 18 and older with histologically confirmed, locally advanced or metastatic solid tumors. The conditions listed include melanoma, mesothelioma, renal cell carcinoma, MSI-high colorectal cancer, hepatocellular carcinoma, and non-small cell lung cancer, among other advanced solid tumors. Pleural mesothelioma is named among the eligible cancers.

Key eligibility requirements from the record include:

• An ECOG performance status of 0 or 1
• A life expectancy of more than 12 weeks
• Measurable disease by RECIST criteria
• Adequate organ function, including renal and hepatic measures

People are excluded for active brain metastasis or leptomeningeal disease, a history of Grade 3 or higher immune-related toxicity from prior therapy (with some exceptions for stable endocrine conditions), uncontrolled cardiac conditions, HIV or hepatitis B or C infection, serious autoimmune disease, active pneumonitis or interstitial lung disease, and pregnancy or lactation. Because the capsules are softgels, the criteria also screen for relevant allergies.

Where the Trial Is Running

The ClinicalTrials.gov record lists five sites in the United States:

• University of Colorado Cancer Center, Aurora, Colorado (recruiting)
• Florida Cancer Specialists, Lake Mary, Florida (completed)
• Dartmouth Hitchcock, Lebanon, New Hampshire (recruiting)
• Brown University Health Cancer Institute, Providence, Rhode Island (recruiting)
• MD Anderson Cancer Center, Houston, Texas (recruiting)

People interested in the study can review the full eligibility criteria and contact details on the ClinicalTrials.gov listing for NCT06362369, then discuss the trial with their own oncologist.

Why This Trial Matters

Most mesothelioma immunotherapy trials work with checkpoint inhibitors that are already approved, testing them earlier in treatment, in new combinations, or against new comparators. This study takes a different angle. It puts a new kind of drug at the center, an oral integrin activator, and uses the checkpoint inhibitors as part of the regimen around it. The question the trial asks first is whether people can safely take alintegimod alongside ipilimumab and nivolumab, and at what dose.

For people with mesothelioma, the value of an early-phase study like this is not a result today. It is the chance that a different mechanism, tested carefully, could add to the options that follow. The trial is still establishing safety, so any conclusions about benefit would be premature.

Limitations to Consider

A Phase 1b dose-escalation study is small and designed to answer narrow questions about safety and dosing. With a target of 126 participants spread across several cancer types, the number of people with mesothelioma specifically will be a fraction of that total, which limits what the study can say about this cancer on its own.

The trial is open at a handful of academic and specialty centers, so geography matters for anyone considering it. And because the record reports no results, it is too early to know whether adding alintegimod changes outcomes. Meaningful efficacy data, if they come, would arrive only after the dose-escalation and later phases are complete.