Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06362369

A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy

Led by 7 Hills Pharma, LLC · Updated on 2026-04-13

126

Participants Needed

5

Research Sites

227 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Histologically confirmed diagnosis of locally advanced or metastatic melanoma, pleural mesothelioma, renal cell carcinoma, MSI-high or mismatch repair-deficient colorectal cancer, hepatocellular carcinoma, or non-small cell lung cancer without EGFR or ALK tumor aberrations, or tumor types approved for ipilimumab and nivolumab
  • Absolute neutrophil count (ANC) of at least 1000/µL without G-CSF use
  • Hemoglobin (Hgb) of at least 9 g/dL without transfusion in the prior 5 days
  • Platelet count of at least 75,000/µL without transfusion in the prior 5 days
  • ECOG performance status of 0 or 1
  • Life expectancy greater than 12 weeks
  • Renal function with eCrCL or eGFR of at least 60 mL/min
  • Hepatic function with ALT/AST less than or equal to 3 times upper limit of normal (ULN), bilirubin less than or equal to 1.5 times ULN (except Gilbert Syndrome); up to 5 times ULN if hepatic metastases
  • Use of contraception for men sexually active with women of child-bearing potential and for women of child-bearing potential before and during treatment
  • All Grade 3 adverse events related to prior therapies resolved to Grade 1 or baseline
  • Measurable disease by RECIST criteria
  • Willingness to allow blood samples for research
Not Eligible

You will not qualify if you...

  • Prior anticancer or radiation therapy within 3 weeks or major surgery within 4 weeks before treatment
  • Active brain metastasis or untreated leptomeningeal disease; treated brain metastasis requires stable disease and off steroids for 2 weeks
  • Prior Grade 3 or higher immune-related toxicity except stable endocrinological adverse events
  • Persistent toxicity greater than Grade 1 from prior therapy except controlled Grade 2 sensory neuropathy, hypothyroidism, or alopecia
  • Use of strong CYP3A inhibitors or inducers within 2 weeks before study
  • Cardiac conditions including myocarditis, uncontrolled hypertension, angina, arrhythmias, heart failure, cardiomyopathy, unstable ischemic heart disease, QTcF ≥470 ms
  • Positive tests for HIV, hepatitis B or C
  • Concurrent malignancies unless previously treated and stable or approved by investigator
  • Severe or uncontrolled medical diseases compromising study participation
  • Use of corticosteroids or immunosuppressives within 14 days except specific low-dose or topical uses
  • Receipt of live attenuated vaccine within 28 days prior to first dose
  • Serious autoimmune diseases such as active inflammatory bowel disease or autoimmune vasculitis
  • Pneumonitis, idiopathic pulmonary fibrosis, interstitial lung disease, or lung disease interfering with pneumonitis assessment
  • Participation in another investigational study within 21 days or 5 half-lives
  • Use of mechanical ventilation, resting oxygen saturation below 90%, renal dialysis, vasopressors, or severe hepatic sinusoidal obstruction syndrome
  • Active systemic infection requiring intravenous antibiotics
  • Pregnant or lactating women
  • Psychiatric or social conditions limiting compliance or informed consent
  • Prior allogeneic tissue or solid organ transplantation
  • Use of biotin supplements exceeding 30 µg daily unless dose reduced
  • Active peptic ulcer disease, gastritis, diverticulitis, or serious gastrointestinal disease affecting oral drug absorption
  • Known soy allergy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

S

Sr. Director Clinical Affairs

CONTACT

V

VP Clinical Affairs and Regulatory

CONTACT

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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