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An Open-label, Multicenter, Dose Escalation Phase 1b Study to Assess the Safety and Pharmacokinetics of Subcutaneous Delivery of Amivantamab, a Human Bispecific EGFR and cMet Antibody for the Treatment of Advanced Solid Malignancies

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Trial Profile

An Open-label, Multicenter, Dose Escalation Phase 1b Study to Assess the Safety and Pharmacokinetics of Subcutaneous Delivery of Amivantamab, a Human Bispecific EGFR and cMet Antibody for the Treatment of Advanced Solid Malignancies

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 11 Mar 2026

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At a glance

  • Drugs Amivantamab (Primary) ; Hyaluronidase (Primary) ; Lazertinib (Primary)
  • Indications Advanced breast cancer; Colorectal cancer; Gastric cancer; Head and neck cancer; Liver cancer; Mesothelioma; Non-small cell lung cancer; Oesophageal cancer; Ovarian cancer; Renal cell carcinoma; Solid tumours; Squamous cell cancer; Thyroid cancer
  • Focus Adverse reactions; Pharmacokinetics
  • Acronyms PALOMA
  • Sponsors Janssen Research & Development

Most Recent Events

  • 23 Feb 2026 According to Johnson & Johnson media release, the company announced that the European Commission (EC) has approved an extension of the RYBREVANT marketing authorisation to include additional subcutaneous (SC) dosing regimens. The approval is supported by results from the Phase 2 PALOMA-2 and Phase 1 PALOMA studies.
  • 12 Sep 2025 Planned End Date changed from 30 Apr 2027 to 31 Dec 2026.
  • 22 Jun 2025 Planned number of patients changed from 166 to 192.

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