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Checkpoint Inhibitor

Dose Escalation - Open Label Phase 1b for Melanoma

Phase 1 & 2
Waitlist Available
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

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 more

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
Ipilimumab
2014
Completed Phase 3
~2620
Nivolumab
2014
Completed Phase 3
~4750

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients to participate in this clinical trial?

"According to clinicaltrials.gov, this particular research project is not actively seeking volunteers. The trial was first listed on April 30th, 2024 and last updated on April 11th, 2024. However, with over five thousand three hundred other trials currently open for enrollment worldwide, there are plenty of opportunities for potential participants."

Answered by AI

What are the main goals and purposes of this investigation?

"The primary aim of this clinical investigation, to be monitored over a span of 12 months, is the assessment of patients treated with Alintegimod in conjunction with treatment-related adverse events as evaluated by CTCAEv5.0 criteria. Secondary objectives comprise understanding the pharmacokinetics of Alintegimod monotherapy through Area Under the Curve (AUC) analysis, characterizing the pharmacokinetics of Alintegimod combined with ipilimumab also via AUC measurements, and evaluating Progression Free Survival (PFS) response in individuals who receive both Alintegimod plus ipilimumab followed by"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy
2024. "A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06362369.
~84 spots leftby Dec 2027
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