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A global, multi-center Phase 1b/2a clinical trial to evaluate Pidnarulex (CX-5461) in combination with tislelizumab in patients with advanced solid tumors, including pancreatic ductal adenocarcinoma (PDAC) and immune checkpoint inhibitor (ICI)-refractory melanoma.

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Trial Profile

A global, multi-center Phase 1b/2a clinical trial to evaluate Pidnarulex (CX-5461) in combination with tislelizumab in patients with advanced solid tumors, including pancreatic ductal adenocarcinoma (PDAC) and immune checkpoint inhibitor (ICI)-refractory melanoma.

Status: Planning
Phase of Trial: Phase I/II

Latest Information Update: 22 Dec 2025

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At a glance

  • Drugs Pidnarulex (Primary) ; Tislelizumab (Primary)
  • Indications Adenocarcinoma; Malignant melanoma; Pancreatic ductal carcinoma; Solid tumours
  • Focus Adverse reactions; Therapeutic Use

Most Recent Events

  • 22 Dec 2025 New trial record
  • 10 Dec 2025 According to Senhwa Biosciences media release, company announced a clinical supply agreement with BeOne Medicines. This agreement will supply a global, multi-center Phase 1b/2a clinical trial to evaluate Senhwas lead compound Pidnarulex (CX-5461) in combination with BeOne's tislelizumab, a PD-1 inhibitor, in patients with advanced solid tumors, including pancreatic ductal adenocarcinoma (PDAC) and immune checkpoint inhibitor (ICI)-refractory melanoma.

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