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Solid TumorPhase 1/2NCT03758664

Clinical Study of ICP-192 in Solid Tumors Patients

A Phase 1/2 study testing ICP-192 in people with Solid Tumor, run by Beijing InnoCare Pharma Tech Co., Ltd. at 7 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Solid Tumor
What is being tested?
ICP-192
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
7 sitesChina
Study dates
19 Dec 2018to 31 Dec 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
  • 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
  • FGFR2 translocation/fusion has been reported or FGFR2 translocation/fusion has been detected in central laboratory (dose extension phase);
  • Age ≥18 and ≤75
  • There is at least one evaluable lesion according to RECIST1.1 criteria
  • ECOG strength score is 0-1 (dose escalation stage), and ECOG strength score is 0-2 (dose expansion stage).
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  • The expected survival time is more than 3 months
  • The organ function level must meet the following requirements (subject to the upper limit of normal value in the clinical trial center):
  • 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).
  • Volunteer to enroll and sign informed consent to follow the treatment protocol and visit plan.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

7 sites in 1 country.

Jin Li, PhD contact

8621-38804518 ext. 22132

lijin@csco.org.cn

7 sites in 1 country

China7 sites, 7 recruiting

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin, 130021

    Wei Li, 0431-88782291, jdyylw@163.com

    Not yet recruiting

  • Hunan cancer hospital & the affiliated cancer hospital of xiangya school of medicine ,central south university

    Changsha, Hunan, 410006

    Shan Zhi Gu, 0731-89762041, gushanzhi@hnszlyy.com

    Not yet recruiting

  • ZhuJiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510000

    Min Wei Ding, 020-62782364, DWM-2001@163.com

    Not yet recruiting

  • Cancer hospital of the university of Chinese academy of sciences

    Hangzhou, Zhejiang, 310022

    Er Jie Ying, 88122502, jieerying01@163.com

    Not yet recruiting

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200120

    Jin Li, PhD

    Recruiting

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004

    Xiang Zhi Zhuang, 68282030, 13951106391@139.com

    Not yet recruiting

  • Henan cancer hospital & Affiliated Tumor Hospital of Zhengzhou University

    Zhengzhou, Henan, 450008

    Fang Xin Hou, 15136130286, zlyyhouxinfang1465@zzu.edu.cn

    Not yet recruiting

Other trials in China

About this study

Official title: 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.

Read the 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).

Conditions
Solid Tumor
Being tested
ICP-192
Keywords
FGFR gene abnormalities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ICP-192Drug

    Drug: ICP-192 Dose levels will be escalated following accelerated titration and modified "3+3" dose escalation scheme,

Study groups in NCT03758664
Study groupRoleWhat they receive
ICP-192ExperimentalThe 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.
Receives: Drug: ICP-192

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events(Phase 1 dose escalation)

    Adverse events graded by CTCAE V5.0 as a measurement of the safety and tolerability profile of ICP-192

    Measured: From the time a signed and dated ICF until 28 days after last dose of study drug

  2. Objective Response Rate(ORR)(Phase 2a dose expansion)

    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).

    Measured: At the end of Cycle 4(each cycle is 21 days)

Secondary outcomes (9)

  1. Cmax

    Single dose PK parameters include the peak plasma concentration (Cmax)

    Measured: At the end of Cycle 1(each cycle is 21 days)

  2. AUC

    Area under the plasma concentration vs. time curve (AUC)

    Measured: At the end of Cycle 1(each cycle is 21 days)

  3. Apparent half-life for designated elimination phases (t½)

    will be measured and calculated with noncompartmental analysis using WinNonlin

    Measured: At the end of Cycle 1(each cycle is 21 days)

  4. Food effect

    ICP-192 concentrations in plasma and urine after dosing in fed and fasted condition

    Measured: Day 1 - 6 after single dose

  5. Objective Response Rate(ORR) (Phase 1 dose escalation)

    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).

    Measured: At the end of Cycle 4(each cycle is 21 days)

  6. Disease control rate(DCR)

    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).

    Measured: At the end of Cycle 4(each cycle is 21 days)

  7. Duration of Objective Response (DOR)

    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

    Measured: At the end of Cycle 4(each cycle is 21 days)

  8. Progression Free Survival (PFS)

    Progression free survival is the time period from start of study medication till the disease progression or death, whichever occurs first.

    Measured: At the end of Cycle 4(each cycle is 21 days)

  9. Correlationship between FGFR aberrations with efficacy. (Phase 2a dose expansion)

    Correlationship between FGFR mutation/refusion with ORR

    Measured: At the end of Cycle 4(each cycle is 21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2018
  2. Study start19 Dec 2018
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03758664
Sponsor's protocol ID
ICP-CL-00301
Status last verified
Jun 2022
First submitted
22 Nov 2018
Last updated
6 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Xue L, Zhu G, Wang P, Yang K, Sun Y, Li W, Li Z, Jiang C, Cai Q, Fang M, Hu M, Ge M, Zhou W, Li S, Guo Y. FGF/FGFR Alteration Type as a Candidate Enrichment Biomarker for Gunagratinib in Recurrent or Metastatic Head and Neck Cancer: An Exploratory Analysis of Two Early-Phase Trials. Target Oncol. 2026 Aug 2. doi: 10.1007/s11523-026-01243-y. Online ahead of print.

    PubMed 42542997

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ICP-192 in people with Solid Tumor, run by Beijing InnoCare Pharma Tech Co., Ltd. at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jin Li, PhD (8621-38804518 ext. 22132, lijin@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03758664, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.

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