Clinical Study of ICP-192 in Solid Tumors Patients

July 5, 2022 updated by: Beijing InnoCare Pharma Tech Co., Ltd.

A Phase I/IIa, Multicenter, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics of ICP-192 in Patients With Advanced Solid Malignancies

Open-label, non-randomized, Phase I/IIa, dose-escalating, dose-extension, first-in-man study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study consisted of a screening period, a treatment period with 21 days of repeated treatment per cycle (duration treatment with ICP-192), and a follow-up period (28 days after last dose). The recruited patients receive a single dose on day 1, then after a 3-day washout period, repeated dosing will be followed. The starting dose is 2 mg, QD, and dose escalation will follow accelerated titration and modified 3+3 dose-finding schema. The dose-limiting toxicity (DLT) assessment period consisted of Cycle 0 (single dose and washout period) and Cycle 1 (21-day cycle).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Not yet recruiting
        • Zhujiang Hospital of Southern Medical University
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Not yet recruiting
        • Henan cancer hospital & Affiliated Tumor Hospital of Zhengzhou University
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410006
        • Not yet recruiting
        • Hunan cancer hospital & the affiliated cancer hospital of xiangya school of medicine ,central south university
        • Contact:
    • Jiangsu
      • Suzhou, Jiangsu, China, 215004
        • Not yet recruiting
        • The Second Affiliated Hospital of Soochow University
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130021
        • Not yet recruiting
        • The First Bethune Hospital of Jilin University
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200120
        • Recruiting
        • Shanghai East Hospital
        • Contact:
          • Jin Li, PhD
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Not yet recruiting
        • Cancer Hospital of The University of Chinese Academy of Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. An unresectable or metastatic advanced malignant solid tumor confirmed by histopathology that has failed to respond to known treatment or has recurred;Subjects who progress under standard treatment, are intolerant to standard treatment, or do not have standard treatment (dose escalation phase)
  2. Tissue or cell pathology confirmed unresectable, recurrent or metastatic (AJCC version 8 TNM staging IV (2017), biliary tract malignant tumor, or intolerance to first-line chemotherapy failure (twice (defined as reduction still cannot tolerate) first-line chemotherapy, neoadjuvant/progress/adjuvant chemotherapy after 6 months recurrence can be selected (dose extension stage); - At least one evaluable disease according to RECIST1.1
  3. FGFR2 translocation/fusion has been reported or FGFR2 translocation/fusion has been detected in central laboratory (dose extension phase);
  4. Age ≥18 and ≤75
  5. There is at least one evaluable lesion according to RECIST1.1 criteria
  6. ECOG strength score is 0-1 (dose escalation stage), and ECOG strength score is 0-2 (dose expansion stage).
  7. The expected survival time is more than 3 months

  8. The organ function level must meet the following requirements (subject to the upper limit of normal value in the clinical trial center):

    A) bone marrow: absolute count of neutrophils (ANC)≥1.5*109/L (1500/mm3), platelet ≥75*109/L, hemoglobin ≥9g/dL; B) coagulation function: international standardized ratio of prothrombin time and partial thrombin time <1.5 times the upper limit of normal value; C) liver: serum bilirubin ≤1.5 times the upper limit of normal value (tumor involvement in the liver ≤2.5 times the upper limit of normal value), aspartic aminotransferase (AST) and alanine aminotransferase (ALT)≤3 times the upper limit of normal value (AST and ALT≤5 times the upper limit of normal value in the case of liver metastasis); D) serum creatinine ≤1.5 times the upper limit of normal value, or creatinine clearance ≥70mL/min (calculated according to the Cockroft-gult formula).

  9. Volunteer to enroll and sign informed consent to follow the treatment protocol and visit plan.

Exclusion Criteria:

  • Previous treatment with FGFR small molecule inhibitors or antibody drugs.
  • Anti-cancer therapy, such as chemotherapy (except for oral fluorouracil), immunotherapy, hormonal, targeted therapy, or investigational agents within four weeks of the first dose of ICP-192, oral fluorouracil agents within two weeks of the first dose of ICP-192.
  • Major surgery within 6 weeks of the first dose of ICP-192.
  • Blood phosphate persistently above ULN with intervene therapy within two weeks of the first dose of ICP-192.
  • Significant GI disorder(s) that could interfere with the absorption, metabolism, or excretion of ICP-192.
  • Central nervous system (CNS) metastasis
  • Current clinically significant cardiovascular disease including:
  • Any class 3 or 4 cardiac disease such as arrhythmia, congestive heart failure or myocardial infarction defined by the New York Heart Association Functional Classification, or left ventricular ejection fraction (LVEF) < 50%, Primary cardiomyopathy, clinical significant QTc prolong history or QTc>470ms (female) QTc>450ms (male)
  • Known active bleeding within 2 months of screening or 6 months of bleeding history.
  • According to the investigator's judgement, there are evidences of a serious or uncontrollable systemic disease (such as unstable or uncompensated respiratory, liver or kidney disease); or any unstable systemic disease (including active clinically serious infections, uncontrolled hypertension, liver and kidney or metabolic diseases)
  • History of interstitial pneumonia, deep vein thrombosis, pulmonary embolism. Stroke or intracranial hemorrhage within 6 months before the first dose of ICP-192.
  • History of organ transplantation and allogeneic hematopoietic stem cell transplantation.
  • Any corneal or retinal abnormalities that may increase ocular toxicity, including but not limited to:
  • History of central serous retinopathy (CSR) or retinal vein occlusion (RVO) disease or has related diseases;
  • Active age-related macular degeneration (AMD);
  • Diabetic retinopathy with macular edema;
  • Uncontrollable glaucoma;
  • Keratonosus, such as Keratitis, keratoconjunctivitis, keratopathy, corneal wear, inflammation or ulceration.
  • Known active infection with HBV, HCV or HIV or any uncontrolled active systemic infection
  • Any toxicities must recover to ≤ Grade 1 from prior anti-cancer therapy (excluding alopecia, nausea and vomiting).
  • Lactating or pregnant women, or women who will not use contraception during the study and for 180 days after the last dose of study drug if sexually active and able to bear children.
  • Investigators believe that the patients are not eligible for enrollment for the other reasons.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: ICP-192
The initial dose of ICP-192 is 2 mg, QD, and dose escalation schedule may be modified based on the safety and PK from the previous dose. Tentatively seven dose levels will be evaluated.
Drug: ICP-192
Drug: ICP-192 Dose levels will be escalated following accelerated titration and modified "3+3" dose escalation scheme,

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse events(Phase 1 dose escalation)
Time Frame: From the time a signed and dated ICF until 28 days after last dose of study drug
Adverse events graded by CTCAE V5.0 as a measurement of the safety and tolerability profile of ICP-192
From the time a signed and dated ICF until 28 days after last dose of study drug
Objective Response Rate(ORR)(Phase 2a dose expansion)
Time Frame: At the end of Cycle 4(each cycle is 21 days)
Objective response based on assessment of confirmed Complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST).
At the end of Cycle 4(each cycle is 21 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: At the end of Cycle 1(each cycle is 21 days)
Single dose PK parameters include the peak plasma concentration (Cmax)
At the end of Cycle 1(each cycle is 21 days)
AUC
Time Frame: At the end of Cycle 1(each cycle is 21 days)
Area under the plasma concentration vs. time curve (AUC)
At the end of Cycle 1(each cycle is 21 days)
Apparent half-life for designated elimination phases (t½)
Time Frame: At the end of Cycle 1(each cycle is 21 days)
will be measured and calculated with noncompartmental analysis using WinNonlin
At the end of Cycle 1(each cycle is 21 days)
Food effect
Time Frame: Day 1 - 6 after single dose
ICP-192 concentrations in plasma and urine after dosing in fed and fasted condition
Day 1 - 6 after single dose
Objective Response Rate(ORR) (Phase 1 dose escalation)
Time Frame: At the end of Cycle 4(each cycle is 21 days)
Objective response based on assessment of confirmed Complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST).
At the end of Cycle 4(each cycle is 21 days)
Disease control rate(DCR)
Time Frame: At the end of Cycle 4(each cycle is 21 days)
DCR based on assessment of confirmed Complete response (CR), partial response (PR) or stable disease(SD) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST).
At the end of Cycle 4(each cycle is 21 days)
Duration of Objective Response (DOR)
Time Frame: At the end of Cycle 4(each cycle is 21 days)
Duration of objective response is time interval from the first date that criteria for complete response or partial response are met to the first date of progression of disease
At the end of Cycle 4(each cycle is 21 days)
Progression Free Survival (PFS)
Time Frame: At the end of Cycle 4(each cycle is 21 days)
Progression free survival is the time period from start of study medication till the disease progression or death, whichever occurs first.
At the end of Cycle 4(each cycle is 21 days)
Correlationship between FGFR aberrations with efficacy. (Phase 2a dose expansion)
Time Frame: At the end of Cycle 4(each cycle is 21 days)
Correlationship between FGFR mutation/refusion with ORR
At the end of Cycle 4(each cycle is 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing InnoCare Pharma Tech Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 19, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ICP-CL-00301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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