OncoMatch/Clinical Trials/NCT06362369
A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy
Is NCT06362369 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Alintegimod and Ipilimumab for advanced cancer.
Treatment: Alintegimod · Ipilimumab · Nivolumab — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Melanoma
Mesothelioma
Renal Cell Carcinoma
Colorectal Cancer
Hepatocellular Carcinoma
Small Cell Lung Cancer
Non-Small Cell Lung Carcinoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: ALK wild-type
Required: EGFR wild-type
Disease stage
Metastatic disease required
locally advanced or metastatic solid tumors
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anticancer therapy
Exception: Palliative radiation therapy is allowed. For small molecules (MW < 0.9 kDA), the washout period is 3 weeks or 5 half-lives, whatever comes first.
Patients must not have received prior anticancer therapy or radiation therapy within the 3 weeks and must not have undergone major surgery within 4 weeks prior to initiation of treatment on protocol.
Cannot have received: major surgery
must not have undergone major surgery within 4 weeks prior to initiation of treatment on protocol
Cannot have received: investigational agent
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.
Lab requirements
Blood counts
ANC ≥ 1000/µL without use of G-CSF, Hgb ≥ 9 g/dL without required blood transfusion for at least 5 days prior to pretreatment baseline, and platelet count ≥ 75,000/µL without transfusions for at least 5 days prior to pretreatment baseline.
Kidney function
eCrCL ≥ 60 mL/min (modified Cockcroft-Gault) or eGFR ≥ 60 mL/min/1.73 m2 (using MDRD or CKD-EPI or similar equations)
Liver function
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.
Cardiac function
QTcF ≥ 470 ms (average from 3 QTcF values on the triplicate 12-lead ECG) at screening; myocarditis; uncontrolled hypertension (blood pressure > 160/100) despite optimal therapy; uncontrolled angina; ventricular arrhythmias; congestive heart failure (NYHA Class II or above); prior or current cardiomyopathy; uncontrolled atrial fibrillation with heart rate > 100 bpm; unstable ischemic heart disease (myocardial infarction within 6 months prior to starting treatment or angina requiring use of nitrates more than once weekly); concomitant medication with drugs known to cause Torsades de Pointes.
Renal and hepatic function requirements: ... Cardiac conditions as follows: myocarditis; uncontrolled hypertension (blood pressure > 160/100) despite optimal therapy; uncontrolled angina; ventricular arrhythmias; congestive heart failure (NYHA Class II or above); prior or current cardiomyopathy; uncontrolled atrial fibrillation with heart rate > 100 bpm; unstable ischemic heart disease (myocardial infarction within 6 months prior to starting treatment or angina requiring use of nitrates more than once weekly); concomitant medication with drugs known to cause Torsades de Pointes; QTcF ≥ 470 ms (average from 3 QTcF values on the triplicate 12-lead ECG) at screening.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Florida Cancer Specialists · Lake Mary, Florida
- Dartmouth Hitchcock · Lebanon, New Hampshire
- Brown University Health Cancer Institute · Providence, Rhode Island
- MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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