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Phase 1/2 Dose Escalation and Cohort Expansion Study Evaluating MCLA-158 (Petosemtamab) as Single Agent or in Combination in Advanced Solid Tumors

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Trial Profile

Phase 1/2 Dose Escalation and Cohort Expansion Study Evaluating MCLA-158 (Petosemtamab) as Single Agent or in Combination in Advanced Solid Tumors

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 12 Mar 2025

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At a glance

  • Drugs Pembrolizumab (Primary) ; Petosemtamab (Primary)
  • Indications Adenocarcinoma; Colorectal cancer; Gastric cancer; Head and neck cancer; Hypopharyngeal cancer; Laryngeal cancer; Mouth neoplasm; Non-small cell lung cancer; Oesophageal cancer; Oropharyngeal cancer; Solid tumours; Squamous cell cancer
  • Focus Adverse reactions; First in man; Registrational; Therapeutic Use
  • Sponsors Merus

    • Most Recent Events

    • 27 Feb 2025 According to a Merus media release, clinical update on phase 2 trial in combination with pembrolizumab in 1L PD-L1+ r/m HNSCC planned for 1H25; phase 2 trial in 1L, 2L and 3L+ metastatic colorectal cancer (mCRC) enrolling; mCRC initial clinical data planned for 2H25.
    • 18 Feb 2025 According to a Merus media release, the company announced that the U.S. FDA has granted second Breakthrough Therapy designation (BTD) to petosemtamab in combination with pembrolizumab for the 1L treatment of adult patients with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma with combined positive score = 1. This second BTD designation follows the initial receipt of BTD and Fast Track designation for petosemtamab. BTD is supported by updated data from this study.
    • 29 Jan 2025 Planned number of patients changed from 567 to 523.

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