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An Open-label, Multi-center, and Dose-escalation, Phase 1/2a Clinical Trial to Assess the Maximum Tolerated Dose(MTD), Safety, and the Anti-tumor Effect of TB511 Monotherapy in Patients With Advanced Solid Tumors Refractory or Intolerant to Standard of Care(SoC) and Pembrolizumab Combination Therapy in Patients With Advanced Solid Tumors Relapsed or Refractory

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Trial Profile

An Open-label, Multi-center, and Dose-escalation, Phase 1/2a Clinical Trial to Assess the Maximum Tolerated Dose(MTD), Safety, and the Anti-tumor Effect of TB511 Monotherapy in Patients With Advanced Solid Tumors Refractory or Intolerant to Standard of Care(SoC) and Pembrolizumab Combination Therapy in Patients With Advanced Solid Tumors Relapsed or Refractory

Status: Not yet recruiting
Phase of Trial: Phase I/II

Latest Information Update: 23 Apr 2025

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At a glance

  • Drugs Pembrolizumab (Primary) ; TB 511 (Primary)
  • Indications Biliary cancer; Carcinoma; Cervical cancer; Colorectal cancer; Endometrial cancer; Gastric cancer; Head and neck cancer; Hodgkin's disease; Liver cancer; Male breast cancer; Malignant melanoma; Non-small cell lung cancer; Oesophageal cancer; Renal cell carcinoma; Solid tumours; Triple negative breast cancer; Urogenital cancer
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Twinpig Biolab

Most Recent Events

  • 18 Apr 2025 Trial protocol amended with new indications melanoma, non-small cell lung cancer, head and neck cancer, classical Hodgkin lymphoma, urothelial carcinoma, gastric cancer, esophageal cancer, renal cell carcinoma, endometrial cancer, microsatellite instability-high (MSI-H) cancer, MSI-H colorectal cancer, triple-negative breast cancer, cervical cancer, biliary tract cancer, and hepatocellular carcinoma.
  • 18 Apr 2025 Planned End Date changed from 1 Oct 2025 to 1 May 2027.
  • 18 Apr 2025 Planned primary completion date changed from 1 Mar 2025 to 1 May 2026.

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