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A Phase 1b/2, Open-Label, Dose Escalation and Expansion Study of ADG126 in Combination With Pembrolizumab (Anti PD-1 Antibody) in Patients With Advanced/Metastatic Solid Tumors

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Trial Profile

A Phase 1b/2, Open-Label, Dose Escalation and Expansion Study of ADG126 in Combination With Pembrolizumab (Anti PD-1 Antibody) in Patients With Advanced/Metastatic Solid Tumors

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 29 Feb 2024

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At a glance

  • Drugs Muzastotug (Primary) ; Pembrolizumab (Primary)
  • Indications Colorectal cancer; Solid tumours
  • Focus Adverse reactions; Proof of concept
  • Sponsors Adagene
  • Most Recent Events

    • 23 Feb 2024 Planned number of patients changed from 72 to 131.
    • 09 Feb 2024 According to an Adagene media release, Follow up of Part 1 evaluable patients at 10 mg/kg Q3W (n=12) and 10 mg/kg Q6W (n=10), data from Part 2 patients at 10 mg/kg Q3W (n=12), evaluation of 20 mg/kg loading doses for Project Optimus requirements: Safety data with repeat doses, dose expansion in MSS CRC (n=10) and additional patients in China (n>-10) are anticipated in 2024.
    • 09 Feb 2024 According to an Adagene media release, company has also received clearance from the CDE in China to initiate clinical evaluation of ADG126 in combination with pembrolizumab.
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