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Checkpoint Inhibitor
Alintegimod + Ipilimumab + Nivolumab for Cancer
Phase 1 & 2
Recruiting
Research Sponsored by 7 Hills Pharma, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial will first test increasing doses of a new treatment in an open-label Phase Ib study. Then, it will compare this treatment to a standard one in a blinded, randomized Phase 2a study
Who is the study for?
This trial is for adults with various advanced cancers, including skin, kidney, liver cancer, and more. Participants must have a specific genetic feature (like Lynch Syndrome) or high levels of certain proteins. Pregnant women and those with autoimmune diseases or other conditions that could interfere with the study are excluded.
What is being tested?
The trial is testing Alintegimod combined with Ipilimumab followed by Nivolumab alone in two parts: Phase 1b to find safe doses and Phase 2a to compare this combo against standard treatments. It's an open-label study initially but will become blinded later on.
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs like the intestines or liver, fatigue, skin issues such as rash or itching, hormone gland problems (thyroid), infusion reactions from the drugs being administered intravenously.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Define RPTDs for Alintegimod
Number of participants treated with Alintegimod in combination with treatment related adverse events as assessed by CTCAEv5.0
Number of participants treated with Alintegimod monotherapy with treatment related adverse events as assessed by CTCAEv5.0
Secondary study objectives
Characterize Pharmacokinetics of Alintegimod monotherapy by measuring Area Under the Curve (AUC)
Characterize Pharmacokinetics of Alintegimod monotherapy by measuring Maximum Plasma Concentration (Cmax)
Characterize Pharmacokinetics of Alintegimod plus ipilimumab by measuring Area Under the Curve (AUC)
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dose Escalation - Open Label Phase 1bExperimental Treatment3 Interventions
Alintegimod dose escalation, 3 cohorts Alintegimod monotherapy 1 cycle Alintegimod + Ipilimumab - 4 cycles Nivolumab - 11 cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2015
Completed Phase 3
~4010
Ipilimumab
2015
Completed Phase 3
~3420
Find a Location
Who is running the clinical trial?
7 Hills Pharma, LLCLead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
Lionel Lewis, MA, MB.Bch, MDStudy Chair7 Hills Pharma