Cancer

ICP-CL-003030

A multi-center open-label, phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ICP-192 in patients with advanced solid tumours and FGFR gene alterations

Trial overview

Topic

Basket – Solid Tumours

Eligibility criteria

  • Participate voluntarily, sign informed consent, and follow the study treatment plan
    and scheduled visits.
  • Phase I: Patients with histologically or cytologically confirmed unresectable or
    metastatic advanced malignant solid tumours who have progressed under standard
    treatment or recurred after or were intolerant to all standard treatment regimens, or
    have no standard treatment available.
  • Phase II: patients with histologically or cytologically confirmed unresectable or
    metastatic urothelial carcinoma or cholangiocarcinoma, who have progressed or recurred
    after or were intolerant to first-line chemotherapy, or have progressed/relapsed
    within 12 months after neoadjuvant /adjuvant chemotherapy.
  • Phase II: Existing test reports have confirmed the FGFR gene alteration or the central
    laboratory has detected the FGFR gene alteration.
    • Age =18 years old
    • At least one measurable lesion according to the Response Evaluation Criteria of Solid
      Tumour, version 1.1 (RECIST 1.1)
    • ECOG performance status of 0-1
    • Life expectancy for more than 3 months; Must have adequate organ function Major

Study details

A multi-center open-label, phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ICP-192 in patients with advanced solid tumours and FGFR gene alterations

Further information

Please click here for more information

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