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A First-in-Human, Open-label, Multicenter, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PYX-201 in Participants With Advanced Solid Tumors

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Trial Profile

A First-in-Human, Open-label, Multicenter, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PYX-201 in Participants With Advanced Solid Tumors

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 13 Aug 2025

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At a glance

  • Drugs Micvotabart-pelidotin (Primary)
  • Indications Adenocarcinoma; Advanced breast cancer; Head and neck cancer; HER2 positive breast cancer; Liver cancer; Non-small cell lung cancer; Ovarian cancer; Pancreatic cancer; Pancreatic ductal carcinoma; Renal cancer; Soft tissue sarcoma; Solid tumours; Squamous cell cancer; Thyroid cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Pyxis Oncology

Most Recent Events

  • 01 Aug 2025 Planned number of patients changed from 120 to 330.
  • 25 Mar 2025 According to a Pyxis Oncology media release, the company announced that data from this trial will be presented in two poster sessions at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, Illinois, held from April 25 to 30, 2025.
  • 25 Mar 2025 According to a Pyxis Oncology media release, the company announced that preliminary data from patients who have received prior platinum and PD-1 inhibitor therapy are expected in the second half of 2025 and preliminary data from patients who have received prior EGFRi and PD-1 inhibitor therapy are expected in the first half of 2026.

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