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Phase 1, First-in-Human, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Patients With Advanced Solid Tumors

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Trial Profile

Phase 1, First-in-Human, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Patients With Advanced Solid Tumors

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 22 Oct 2025

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At a glance

  • Drugs TGW 101 (Primary)
  • Indications Adenocarcinoma; Breast cancer; Carcinoma; Cervical cancer; Endometrial cancer; Gastric cancer; Head and neck cancer; HER2 positive breast cancer; Male breast cancer; Non-small cell lung cancer; Oesophageal cancer; Ovarian cancer; Prostate cancer; Salivary gland cancer; Solid tumours; Triple negative breast cancer
  • Focus Adverse reactions; First in man
  • Sponsors Tagworks Pharmaceuticals

Most Recent Events

  • 09 Sep 2025 According to Tagworks Pharmaceuticals media release, company look forward to sharing preliminary data from the study, including safety, pharmacokinetics, and potential early signs of clinical activity, in early to mid-2026.
  • 09 Sep 2025 According to Tagworks Pharmaceuticals media release, To date, the trial has initiated three dose levels following favorable safety reviews by the Safety Oversight Committee (SOC). Up to seven dose levels are currently planned, and the maximum dose to be evaluated may be updated based on evolving clinical safety and pharmacokinetic data. The study aims to enroll patients across sites in the United States, with potential expansion to additional regions.
  • 22 Apr 2025 According to Tagworks Pharmaceuticals media release, Anthony Tolcher is primary investigator in this trial.

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