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A Phase 1a/1b, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of IMGS-001 in Patients with Relapsed or Refractory Advanced Solid Tumors

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Trial Profile

A Phase 1a/1b, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of IMGS-001 in Patients with Relapsed or Refractory Advanced Solid Tumors

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 26 Dec 2025

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At a glance

  • Drugs IMGS-001 (Primary)
  • Indications Adenocarcinoma; Colorectal cancer; Gastric cancer; Head and neck cancer; Nasopharyngeal cancer; Non-small cell lung cancer; Oesophageal cancer; Ovarian cancer; Prostate cancer; Solid tumours
  • Focus Adverse reactions; First in man; Proof of concept
  • Sponsors IMMUNOGENESIS

Most Recent Events

  • 04 Dec 2025 event According to an IMMUNOGENESIS media release, the company has received $10.8 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT) to support the the phase 1b dose-expansion portion of the trial across multiple solid tumor cohorts.
  • 10 Sep 2025 Protocol amended to increase maximum dose form 15 mg/kg to 20 mg/kg. Inclusion criteria updated to include microsatellite stable colorectal cancer, small cell lung cancer, nasopharyngeal and Head and neck cancer.
  • 01 Jul 2025 According to an IMMUNOGENESIS media release, the company has announced appointment of a six-member of Scientific Advisory Board (SAB) Initial meeting to discuss clinical data and provide input on the IMGS-001 Phase 1a/1b study.

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