Study on Oral Alintegimod with Ipilimumab and Nivolumab for Cancer Treatment

Sponsor: 7 Hills Pharma, LLC

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06362369

Provider View

This clinical trial is testing a new treatment approach using oral Alintegimod combined with ipilimumab, followed by nivolumab alone, to evaluate its safety and effectiveness in treating cancer.

Patient Parameters

Program Overview

This study is exploring a new cancer treatment that starts with oral Alintegimod, combined with ipilimumab, and then continues with nivolumab alone. The goal is to assess how safe and effective this combination is for patients. Initially, the study will focus on determining the right dose and safety in Phase 1b, and later compare different treatment regimens in Phase 2a.

Description

The trial is designed to test the safety and initial effectiveness of a new treatment plan for cancer. It begins with taking Alintegimod by mouth, combined with the drug ipilimumab, and then continues with nivolumab alone. Patients will receive nivolumab after completing the combination treatment with Alintegimod and ipilimumab, continuing for up to 12 months unless the cancer progresses or side effects occur. The study aims to find out if this treatment plan can help manage cancer effectively.

Eligibility Criteria

Exclusion Criteria

  • No prior cancer treatment or radiation therapy within the last 3 weeks, and no major surgery within 4 weeks before starting the study treatment. Palliative radiation is allowed.
  • No active brain cancer or cancer in the membranes covering the brain and spinal cord. Treated brain cancer must be stable for at least 4 weeks, with no steroid use for 2 weeks before starting the study drug.
  • No history of severe immune-related side effects from previous treatments, except for stable conditions like hypothyroidism or diabetes.
  • No ongoing severe side effects from previous treatments, except for manageable conditions like mild nerve damage or controlled diabetes.
  • No use of certain medications or foods that affect liver enzymes within 2 weeks before starting the study.
  • No serious heart conditions, such as myocarditis, uncontrolled high blood pressure, or recent heart attack.
  • No positive tests for HIV, hepatitis B, or hepatitis C.
  • No other active cancers unless they were treated over 2 years ago or are stable and not requiring treatment.
  • Men and women of childbearing potential must use contraception during and after treatment.
  • No severe or uncontrolled medical conditions that could affect participation, like uncontrolled diabetes or severe infections.
  • No use of steroids or immunosuppressive drugs within 14 days before starting Alintegimod, except for certain low-dose or topical steroids.
  • No recent live vaccines within 28 days before starting Alintegimod.
  • No serious autoimmune diseases like Crohn's disease or lupus.
  • No history of lung diseases that could interfere with the study.
  • No participation in other investigational drug studies within 21 days before starting this study.
  • No need for mechanical ventilation or low oxygen levels.
  • No ongoing infections requiring IV antibiotics.
  • Not pregnant or breastfeeding, and women must have a negative pregnancy test before starting treatment.
  • No psychiatric or social issues that could affect study participation.
  • No history of organ transplants, but prior T cell therapy is allowed.
  • No use of high-dose biotin supplements.
  • No conditions that could affect participation, as judged by the investigator.
  • No active stomach or intestinal diseases that could affect drug absorption.
  • No known soy allergy.

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