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A Phase I/II, multi-centre, open-label, adaptive design, umbrella study assessing the safety, tolerability, immunogenicity and efficacy of IN01 in combination with small-molecule inhibitors in two cohort of patients with either constitutively RAS or BRAF mutated unresectable metastatic colorectal cancer eligible for second line treatment.

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Trial Profile

A Phase I/II, multi-centre, open-label, adaptive design, umbrella study assessing the safety, tolerability, immunogenicity and efficacy of IN01 in combination with small-molecule inhibitors in two cohort of patients with either constitutively RAS or BRAF mutated unresectable metastatic colorectal cancer eligible for second line treatment.

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 11 Mar 2022

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At a glance

  • Drugs Encorafenib (Primary) ; IN 01 (Primary) ; Trametinib (Primary)
  • Indications Adenocarcinoma; Colon cancer; Rectal cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms CRAcIm 1
  • Sponsors In3Bio

    • Most Recent Events

    • 09 Mar 2022 According to an In3Bio media release, the company is in the process of a Series A financing round for this trial.
    • 09 Mar 2022 According to an In3Bio media release, the company has received Clinical Trial Application approval from the British Medicines & Healthcare Products Regulatory Agency (MHRA) to initiate this trial. This is the company's second global regulatory approval for the trial.
    • 08 Jun 2021 According to an In3Bio media release, the company has received the Clinical Trial Application approval from the Bulgarian Drug Agency and Ethical Committee to initiate a Phase I/II clinical trial of its colorectal cancer vaccine in Bulgaria.
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