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New treatment option for Advanced Cancer
Official title A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy
ClinicalTrials.gov ID: NCT06362369
What this study is testing
What is Alintegimod?
Alintegimod is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced cancer.
Also referred to as 7HP349.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Inclusion and
You likely can't join if
- for Phase 1b Inclusion Criteria
- Adult patients (age 18 or older)
- Patient has a histologically confirmed diagnosis of any of the following locally advanced or metastatic solid tumors: melanoma, pleural mesothelioma...
- 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...
- ECOG performance status of 0 or 1.
- Has a life expectancy of \> 12 weeks.
See the full eligibility criteria
Who can join
- Inclusion and
What rules you out
- for Phase 1b Inclusion Criteria
- Adult patients (age 18 or older)
- Patient has a histologically confirmed diagnosis of any of the following locally advanced or metastatic solid tumors: melanoma, pleural mesothelioma, renal cell carcinoma, MSI-high or mismatch repair-deficient...
- 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...
- ECOG performance status of 0 or 1.
- Has a life expectancy of \> 12 weeks.
- Renal and hepatic function requirements:
- 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.
- Men receiving the investigational drug and are sexually active with women of child-bearing potential (WCBP) must use contraception during treatment and for 5 half-lives after the last dose of the investigational drug or...
- All Grade 3 AEs related to prior therapies have returned to Grade 1 or resolved to baseline (this includes with appropriate therapy in the case of thyroid dysfunction).
- All patients must have measurable disease by applicable RECIST criteria.
- Willing to allow blood samples to be used for research. Exclusion Criteria:
- 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. Palliative...
- Active brain metastasis or leptomeningeal disease. Patients with treated brain metastasis must have stable disease, evidenced by MRI brain imaging for at least 4 weeks, and the patient must have been off steroids for at...
- Previous episodes of ≥ Grade 3 (G3) immune-related toxicity that includes G3 colitis, G3 pneumonitis, G3 skin rash, G3 increase in liver enzymes (with the exception of symptoms that in the opinion of the investigator...
- Persistent toxicity of NCI CTCAE version 5 Grade \> 1 severity that is related to prior therapy. Note: Sensory neuropathy, hypothyroidism or alopecia of Grade ≤ 2 are acceptable. Other Grade 2 toxicities of prior...
- Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome p450 3A (CYP3A) within 2 weeks before study intervention. Alintegimod may increase exposure to CYP3A4 substrates...
- The patient has cardiac conditions as follows:
- 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...
- 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.
- Known history of a positive test for HIV, or positive test for hepatitis B (positive for HBsAg) or hepatitis C (HCV RNA).
- 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...
- Men receiving the investigational drug and are sexually active with women of child-bearing potential (WOCBP) must use contraception during treatment and for 5 half-lives after the last dose of the investigational drug...
- The patient has concurrent severe and/or uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes, severe infection requiring active treatment, severe malnutrition...
- Use of corticosteroids or other immunosuppressive medication, current or within 14 days of administration of Alintegimod with the following exceptions:
- 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.
- Receipt of live attenuated vaccine within 28 days of the first dose of Alintegimod.
- 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...
- 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 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.
- 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.
- Proven or suspected ongoing systemic infection requiring IV antibiotics.
- Women who are pregnant or lactating. Note: Women of childbearing potential (WOCBP) must have a "negative" serum pregnancy test within 1 week prior to treatment. Non-childbearing potential is defined as 1 of the...
- 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). Note: Tubal ligation is not...
- Psychiatric illness/social circumstances that would limit compliance with study requirements and substantially increase the risk of adverse events or have compromised ability to provide written informed consent.
- Patients who have had allogeneic tissue or solid organ transplantation. Prior T cell therapy is allowed
- Use of biotin (i.e., Vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 µg (NIH-ODS 2022; Section 5.9.2.1). Note: Patients who switch from a high dose to a dose of ≤30 µg/day are...
- Any condition that is in the opinion of the investigator may compromise patient's participation in the trial.
- Active peptic ulcer disease or gastritis, active diverticulitis, or other serious gastrointestinal disease associated with diarrhea within the past 2 years before the start of therapy or GI disease which affects oral...
- Patients with known soy allergy.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Lake Mary, Florida, United States
- Lebanon, New Hampshire, United States
- Providence, Rhode Island, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Lake Mary, Florida, United States; Lebanon, New Hampshire, United States; Providence, Rhode Island, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.