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A Phase 1b/2a Multi-Center, Dose Escalation and Reference Regimen-Controlled, Multi-Cohort Study to Determine the Safety and Efficacy of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy in Patients With Anti-PD-1-Resistant Locally Advanced or Metastatic Cancers

Trial Profile

A Phase 1b/2a Multi-Center, Dose Escalation and Reference Regimen-Controlled, Multi-Cohort Study to Determine the Safety and Efficacy of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy in Patients With Anti-PD-1-Resistant Locally Advanced or Metastatic Cancers

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 27 Nov 2024

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At a glance

  • Drugs Alintegmod (Primary) ; Ipilimumab (Primary) ; Nivolumab (Primary)
  • Indications Colorectal cancer; Liver cancer; Malignant melanoma; Mesothelioma; Non-small cell lung cancer; Renal cell carcinoma; Solid tumours
  • Focus Adverse reactions
  • Sponsors 7 Hills Pharma
  • Most Recent Events

    • 03 Sep 2024 According to a 7 Hills Pharma media release, this study is supported by a $13.4 million award from the Cancer Prevention and Research Institute of Texas (DP230062) and a $2.0 million award from the National Cancer Institute (R44CA285207).
    • 03 Sep 2024 According to a 7 Hills Pharma media release, first cancer patient has been safely dosed with alintegimod in this study.
    • 29 Jul 2024 Planned initiation date changed from 30 Apr 2024 to 1 Aug 2024.

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