Actively Recruiting
A Phase 1b/2a Multi-Center Study Evaluating Safety and Efficacy of Oral 7HP349 (Alintegimod) Combined With Ipilimumab Followed by Nivolumab Monotherapy in Patients With Locally Advanced or Metastatic Cancers After Prior Therapies
Led by 7 Hills Pharma, LLC · Updated on 2026-04-13
126
Participants Needed
5
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating oral Alintegimod (7HP349) alone and in combination with ipilimumab, followed by nivolumab monotherapy, in patients with locally advanced or metastatic cancers who have received one or more prior therapies. This open-label Phase Ib dose escalation study is followed by a blinded, randomized multi-cohort Phase 2a comparison of combination versus reference regimens, aiming to assess safety, tolerability, and preliminary efficacy. Participants will receive Alintegimod monotherapy in escalating doses for one cycle, then Alintegimod combined with ipilimumab for four cycles, followed by nivolumab monotherapy for eleven cycles. Alintegimod is given orally as softgel capsules, while ipilimumab and nivolumab are administered intravenously. The treatment continues until the end of the study period, lasting 12 months, unless disease progression or toxicity requires early termination. Throughout the study, participants will undergo assessments including adverse event monitoring, pharmacokinetic testing, and tumor response evaluations using RECIST criteria. Researchers will measure treatment-related side effects, drug levels in the blood, progression-free survival, and overall response rates. Safety will be closely monitored over 18 months, with participants expected to attend regular visits for clinical evaluations and laboratory tests during the study duration.
CONDITIONS
Brief Title
A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 or older
- Histologically confirmed diagnosis of specified locally advanced or metastatic solid tumors including melanoma, pleural mesothelioma, renal cell carcinoma, MSI-high or mismatch repair-deficient colorectal cancer, hepatocellular carcinoma, and non-small cell lung cancer without EGFR or ALK genomic tumor aberrations, or tumor types with FDA-approved ipilimumab and nivolumab combination
- Absolute neutrophil count (ANC) of at least 1000/µL without G-CSF use
- Hemoglobin level of at least 9 g/dL without blood transfusion for at least 5 days before baseline
- Platelet count of at least 75,000/µL without transfusions for at least 5 days before baseline
- ECOG performance status of 0 or 1
- Life expectancy greater than 12 weeks
- Renal function with estimated creatinine clearance or glomerular filtration rate at least 60 mL/min
- Hepatic function with ALT/AST less than or equal to 3 times upper limit of normal, total bilirubin less than or equal to 1.5 times upper limit of normal (exceptions for Gilbert Syndrome and hepatic metastases)
- Use of contraception for men and women of child-bearing potential during and after treatment as specified
- All Grade 3 adverse events from prior therapies resolved to Grade 1 or baseline
- Presence of measurable disease by applicable RECIST criteria
- Willingness to allow blood samples for research
You will not qualify if you...
- Received anticancer therapy or radiation therapy within 3 weeks before starting treatment, or major surgery within 4 weeks prior
- Active brain metastasis or leptomeningeal disease, unless stable and off steroids for required periods
- Previous Grade 3 or higher immune-related toxicities (with some exceptions)
- Persistent toxicity greater than Grade 1 related to prior therapy, except certain controlled conditions
- Use of strong CYP3A inhibitors or inducers within 2 weeks before study intervention
- Certain cardiac conditions including uncontrolled hypertension, myocarditis, arrhythmias, heart failure, or prolonged QT interval
- Positive test for HIV, hepatitis B, or hepatitis C
- Concurrent malignancies not meeting specified stability and treatment criteria
- Severe or uncontrolled medical diseases that could affect participation
- Use of corticosteroids or immunosuppressants within 14 days except specified exceptions
- Recent live attenuated vaccine within 28 days before treatment
- Serious autoimmune diseases or active lung diseases that interfere with assessment
- Recent participation in other investigational studies
- Use of mechanical ventilation or requiring certain supportive treatments
- Active systemic infections requiring IV antibiotics
- Pregnancy or lactation
- Psychiatric or social conditions limiting compliance
- Prior allogeneic tissue or solid organ transplantation
- Use of high-dose biotin supplements
- Gastrointestinal diseases affecting drug absorption
- Known soy allergy
- Any condition that may compromise participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 12 months or until disease progression or unacceptable toxicity
Participants receive oral Alintegimod monotherapy for 1 cycle, followed by combination treatment with Alintegimod and ipilimumab for 4 cycles. Afterward, participants receive nivolumab monotherapy.
Multiple visits for treatment administration and monitoring, including IV infusions for ipilimumab and nivolumab
Trial Site Locations
Total: 5 locations
1
University of Colorado Cancer Center
Aurora, Colorado, United States, 84005
Actively Recruiting
2
Florida Cancer Specialists
Lake Mary, Florida, United States, 32746
Completed
3
Dartmouth Hitchcock
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
4
Brown University Health Cancer Institute
Providence, Rhode Island, United States, 02906
Actively Recruiting
5
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Sr. Director Clinical Affairs
V
VP Clinical Affairs and Regulatory
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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