Study of Alintegimod with Ipilimumab and Nivolumab for Advanced Cancer
This study is testing a new oral medicine called Alintegimod, first by itself, and then in combination with two IV (intravenous) medicines, ipilimumab (Yervoy) and nivolumab (Opdivo). It's for adults aged 18 and older with advanced solid tumors like melanoma, pleural mesothelioma, or certain other cancers. The main goals are to see how safe Alintegimod is, both alone and in combination, and to find the right dose. Researchers will also look at how well the treatment works. The study plans to enroll 126 participants.
- Study design
- This is an open-label Phase 1b study, meaning you and your doctors will know what treatments you are receiving. It will enroll 126 participants.
- What's involved
- You will receive Alintegimod by mouth, and ipilimumab and nivolumab through an IV. Nivolumab treatment will continue for up to 12 months unless your condition worsens or side effects become too severe.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess side effects for up to 1 year for Alintegimod alone and in combination, and define the recommended dose within 18 months.
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NCT06362369
A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy
Recruiting
PHASE1Ages 18+InterventionalTreatment7 Hills Pharma, LLC
~126 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:AlintegimodIpilimumabNivolumab
At a glance
Recruiting sites
4 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants treated with Alintegimod monotherapy with treatment related adverse events as assessed by CTCAEv5.0
Measured over 1 year
+2 more outcomes measured
Conditions
Where it's being run
5 sites across 5 statesColorado1
Florida1
New Hampshire1
Rhode Island1
Texas1
Study leadership
- Lionel Lewis, MA, MB.Bch, MD · STUDY_CHAIR · 7 Hills Pharma
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
a. Renal function with either an eCrCL ≥ 60 mL/min (modified Cockcroft-Gault) or eGFR ≥ 60 mL/min/1.73 m2 (using MDRD or CKD-EPI or similar equations).
b. Hepatic function with ALT/AST ≤ 3 x ULN, total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert Syndrome). If patients have hepatic metastases, then AST/ALT≤ 5 x ULN will be allowed.
Exclusion
a) myocarditis;
b) uncontrolled hypertension (blood pressure \> 160/100) despite optimal therapy;
c) uncontrolled angina; ventricular arrhythmias; congestive heart failure (New York Heart Association Class II or above);
d) prior or current cardiomyopathy;
e) uncontrolled atrial fibrillation with heart rate \> 100 beats per minute (bpm); unstable ischemic heart disease (myocardial infarction within 6 months prior to starting treatment or angina requiring use of nitrates more than once weekly);
f) concomitant medication with drugs known to cause Torsades de Pointes;87
g) QT interval correction for heart rate using Fridericia's formula (QTcF) ≥ 470 ms (average from 3 QTcF values on the triplicate 12-lead electrocardiogram \[ECG\]) at screening. 7. Known history of a positive test for HIV, or positive test for hepatitis B (positive for HBsAg) or hepatitis C (HCV RNA). 8. Concurrent malignancies are permitted if they were previously treated, and all treatment of that malignancy was completed at least 2 years before enrollment and no evidence of disease exists, or with agreement from the Principal Investigator (PI), patients who have a concurrent malignancy that is clinically stable and does not require tumor-directed treatment are eligible to participate if the risk of the prior malignancy interfering with either safety or efficacy endpoints is very low, or with agreement from the PI, other malignancies may be permitted if the risk of the prior malignancy interfering with either safety or efficacy end points is very low. Adequately treated basal or squamous cell carcinoma or carcinoma in situ is allowed.
a) Topical, intranasal, inhaled, ocular, intra-articular corticosteroids;
b) Physiological doses of replacement corticosteroids (e.g., for adrenal insufficiency) are not to exceed 10 mg/day of prednisone or equivalent.
c) Corticosteroid premedication for infusion and/or hypersensitivity reactions.
d) Patients may be treated with a short (\<24h) pulse course of corticosteroids to mitigate infusion or hypersensitivity reactions to radiocontrast agents. 12. Receipt of live attenuated vaccine within 28 days of the first dose of Alintegimod. 13. Serious autoimmune disease at the discretion of the treating Investigator: patients with a history of active serious inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus or autoimmune vasculitis (e.g., Wegener's Granulomatosis) are excluded from participation in this study 14. Active or history of pneumonitis (drug-induced), idiopathic pulmonary fibrosis, Interstitial Lung Disease (ILD), or lung disease that may interfere with assessment of pneumonitis. History of radiation pneumonitis in a previous radiation field is permitted. 15. Previous participation in a study of any investigational agent within 21 days of enrollment or within 5 half-lives of the study treatment, whichever is the least. 16. Use of mechanical ventilation or having a resting O2 saturation \< 90% (on room air) by pulse-oximetry, require renal dialysis, require vasopressors, and/or severe hepatic sinusoidal obstruction syndrome. 17. Proven or suspected ongoing systemic infection requiring IV antibiotics. 18. Women who are pregnant or lactating.
a) Postmenopausal with \> 1 year since last menses and:
1\. If ≥ 65 years old, follicle-stimulating hormone (FSH) \> 40 mIU/mL.
2\. If ≥ 65 years old and not on hormone replacement therapy (HRT), FSH \> 30 mIU/mL.
3\. If ≥ 65 years old and on HRT, the FSH requirement is not applicable. Postmenopausal females on HRT will be allowed if HRT has been stable for ≥ 6 months prior to dosing of study drug(s).
b) Written medical documentation of being sterilized (e.g., hysterectomy, double oophorectomy, bilateral salpingectomy) with the procedure performed ≥ 6 months prior to dosing study drug(s).
What this trial measures
- Number of participants treated with Alintegimod monotherapy with treatment related adverse events as assessed by CTCAEv5.01 year
To evaluate the safety and tolerability of Alintegimod administered as monotherapy, in the patients with adverse events as assessed by CTCAE v5.0 and coded by System Organ Class (SOC) using MedDRA coding dictionary
- Number of participants treated with Alintegimod in combination with treatment related adverse events as assessed by CTCAEv5.01 year
To evaluate the safety and tolerability of Alintegimod administered in combination with ipilimumab followed by sequential nivolumab monotherapy, in the number of patients with adverse events as assessed by CTCAE v5.0 and coded by System Organ Class (SOC) using MedDRA coding dictionary
- Define RPTDs for Alintegimod18 months
To define two doses of the Alintegimod + ipilimumab followed by nivolumab cohorts that will be used in the Phase 2a (Part B) study.