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Clinical Trial Summary

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


Clinical Trial Description

This Phase study is designed to evaluate the safety, tolerability, and preliminary efficacy of oral Alintegimod (Alintegimod) alone, and then in combination with ipilimumab for, followed by nivolumab monotherapy cycles. All patients will receive nivolumab after completion of treatment with Alintegimod plus ipilimumab combination therapy to continue nivolumab treatment until the end of study (12 months) unless progression or toxicity result in early termination. ;


Study Design


Related Conditions & MeSH terms

  • Advanced Cancer
  • Advanced Solid Tumor
  • Carcinoma
  • Carcinoma, Hepatocellular
  • Carcinoma, Renal Cell
  • Colorectal Cancer
  • Hepatocellular Cancer
  • Hepatocellular Carcinoma
  • Kidney Cancer
  • Kidney Neoplasms
  • Liver Neoplasms
  • Melanoma
  • Mesothelioma
  • Metastasis
  • Mismatch Repair Deficiency
  • Non Small Cell Lung Cancer
  • NSCLC
  • Pleural Mesothelioma
  • Renal Cell Cancer
  • Renal Cell Carcinoma
  • Skin Cancer

NCT number NCT06362369
Study type Interventional
Source 7 Hills Pharma, LLC
Contact Sr. Director Clinical Affairs
Phone 1.210.279.1998
Email nicole@7hillspharma.com
Status Recruiting
Phase Phase 1/Phase 2
Start date May 20, 2024
Completion date December 31, 2028

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