Clinical Trials /

A Study of ICP-192 in Patients With Advanced Solid Tumors

NCT04565275

Description:

This is a multi-center, open-label, phase I/II clinical study to evaluate ICP-192 in patients with advanced solid tumors and FGFR gene alterations. It consists of two parts: Part I (Phase I), dose escalation and Part II (Phase II), dose expansion.

Related Conditions:
  • Cholangiocarcinoma
  • Malignant Solid Tumor
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of ICP-192 in Patients With Advanced Solid Tumors
  • Official Title: 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 Tumors and FGFR Gene Alterations

Clinical Trial IDs

  • ORG STUDY ID: ICP-CL-00303
  • NCT ID: NCT04565275

Conditions

  • Advanced Solid Tumors
  • Urothelial Carcinoma
  • Cholangiocarcinoma

Interventions

DrugSynonymsArms
Drug ICP-192ICP-192

Purpose

This is a multi-center, open-label, phase I/II clinical study to evaluate ICP-192 in patients with advanced solid tumors and FGFR gene alterations. It consists of two parts: Part I (Phase I), dose escalation and Part II (Phase II), dose expansion.

Detailed Description

      Part I (Phase I) of the study enrolls patients with advanced solid tumors (9-15 patients);
      Part II (Phase II) of the study enrolls patients with urothelial carcinoma or
      cholangiocarcinoma with FGFR genetic alterations (30 patients).
    

Trial Arms

NameTypeDescriptionInterventions
ICP-192ExperimentalDose Escalation Phase ICP-192 Dose Expansion Phase ICP-192
  • Drug ICP-192

Eligibility Criteria

        Major Inclusion Criteria

        Participants are eligible to be included in the study only if all of the following criteria
        apply:

          1. Participate voluntarily, sign informed consent, and follow the study treatment plan
             and scheduled visits;

          2. Phase I: Patients with histologically or cytologically confirmed unresectable or
             metastatic advanced malignant solid tumors who have progressed under standard
             treatment or recurred after or were intolerant to all standard treatment regimens, or
             have no standard treatment available;

          3. 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;

          4. Phase II: Existing test reports have confirmed the FGFR gene alteration or the central
             laboratory has detected the FGFR gene alteration.

          5. Age ≥18 years old;

          6. At least one measurable lesion according to the Response Evaluation Criteria of Solid
             Tumor, version 1.1 (RECIST 1.1);

          7. ECOG performance status of 0-1;

          8. Life expectancy for more than 3 months; Must have adequate organ function Major
             Exclusion Criteria

        Participants are excluded from the study if any of the following criteria apply:

          1. Have previously been treated with selective pan-FGFR molecular inhibitors or antibody
             drugs, except for the FGFR4 selective inhibitors;

          2. Within 2 weeks before the first dose of study drug, the subject's phosphate level
             continuing to exceed the ULN despite medical treatment;

          3. Patients with clinically significant gastrointestinal dysfunction

          4. Has known central nervous system metastases;

          5. Has a history of or currently uncontrolled cardiovascular diseases

          6. History of organ transplantation or a history of allogeneic hematopoietic stem cell
             transplantation;

          7. Current evidence of corneal or retinal abnormalities that may increase eye toxicity;

          8. Active hepatitis B virus active hepatitis C, or HIV infection;

          9. Has not recovered from reversible toxicity of prior anti-tumor therapy

         10. Pregnant or lactating women, as well as women with childbearing potential who are
             unwilling or unable to perform contraception from the screening to 6 months after the
             last study drug administration; and fertile men who are unwilling or unable to perform
             contraception from screening to 3months after the last study drug administration

         11. Other conditions considered by the investigator to be inappropriate for participation
             in this study.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame:Up to 3 years
Safety Issue:
Description:Phase I: Dose Escalation & Phase II: Dose Expansion To evaluate the safety and tolerability of different doses of ICP-192 in patients with advanced solid tumors

Secondary Outcome Measures

Measure:Peak concentration (Cmax)
Time Frame:Up to 3 years
Safety Issue:
Description:Phase I: Dose Escalation Peak concentration (Cmax)
Measure:AUC
Time Frame:Up to 3 years
Safety Issue:
Description:Phase I: Dose Escalation AUC
Measure:DCR
Time Frame:Up to 3 years
Safety Issue:
Description:Phase II: Dose Expansion disease control rate
Measure:DOR
Time Frame:Up to 3 years
Safety Issue:
Description:Phase II: Dose Expansion duration of response
Measure:PFS
Time Frame:Up to 3 years
Safety Issue:
Description:Phase II: Dose Expansion progression-free survival
Measure:OS
Time Frame:Up to 3 years
Safety Issue:
Description:Phase II: Dose Expansion overall survival

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Beijing InnoCare Pharma Tech Co., Ltd.

Last Updated

September 21, 2020