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Advanced Solid TumorsPhase 1/2NCT04565275

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

A Phase 1/2 study testing Drug ICP-192 in people with Advanced Solid Tumors and Urothelial Carcinoma, run by Beijing InnoCare Pharma Tech Co., Ltd. at 16 sites in 2 countries.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Drug ICP-192
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
16 sitesin 2 countries
Study dates
1 Feb 2021to 15 Apr 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

16 sites in 2 countries.

Olivia Yang contact

+1 (609) 524-0684

olivia.yang@INNOCAREPHARMA.COM

16 sites in 2 countries

United States9 sites, 9 recruiting

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012

    Manojkumar Bupathi

    Recruiting

  • The Ohio State University

    Columbus, Ohio, 43210

    Sameek Roychowdhury

    Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77001

    Neal Akhave

    Recruiting

  • University of California, San Diego (UCSD) - Moores Cancer Center

    La Jolla, California, 92037

    Shumei Kato

    Recruiting

  • Clinical Research Alliance

    Lake Success, New York, 11042

    James D'Olimpio

    Recruiting

  • Minnesota Oncology Hematology

    Minneapolis, Minnesota, 55404

    Timothy Larson

    Recruiting

  • Mid Florida Hematology and Oncology

    Orange City, Florida, 32763

    Santosh Nair, MD

    Not yet recruiting

  • Rutgers Cancer Institute of New Jersey

    The Bronx, New York, 10462

    Sanjay Goel

    Recruiting

  • Arizona Oncology

    Tucson, Arizona, 85711

    Sudhir Manda, MD, 520-886-0206

    Recruiting

Other trials in United States

Australia7 sites, 7 recruiting

  • Pindara Private Hospital

    Benowa, Queensland, 4217

    Marco Matos

    Recruiting

  • Monash Medical Centre Clayton

    Clayton, Victoria, 3168

    Elizabeth Ahern

    Recruiting

  • Peninsula & South Eastern Haematology & Oncology Group

    Frankston, Victoria, 3199

    Vinod Ganju

    Recruiting

  • Macquarie University Hospital

    Macquarie Park, New South Wales, 2109

    Alison Zhang

    Recruiting

  • Olivia Newton-John Cancer Research Institute

    Melbourne, Victoria, 3084

    Andrew Weickhardt

    Recruiting

  • GenesisCare - North Shore

    St Leonards, New South Wales, 1590

    Adrian Lee

    Recruiting

  • Westmead Hospital

    Westmead, New South Wales, 2145

    Ka Yeung Mark Wong

    Recruiting

Other trials in Australia

About this study

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

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.

Read the 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).

Being tested
Drug ICP-192
Medical subject headings
Carcinoma, Transitional Cell, Cholangiocarcinoma

What participants receive

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

  • Drug ICP-192Drug

    1. Dose Escalation Phase ICP-192 will be taken by patients with advanced solid tumor and will be treated follow the "3+3" dose escalation scheme
    2. Dose Expansion Phase ICP-192 will be taken by patients with urothelial carcinoma or cholangiocarcinoma with FGFR gene alterations and will be treated at a single dose defined from the Dose Escalation Phase.
Study groups in NCT04565275
Study groupRoleWhat they receive
ICP-192Experimental1. Dose Escalation Phase ICP-192 2. Dose Expansion Phase ICP-192
Receives: Drug: Drug ICP-192

What is being measured

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

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    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

    Measured: Up to 3 years

  2. MTD

    Phase I: Dose Escalation To determine Maximum Tolerated Dose（MTD) for ICP-192

    Measured: Up to 3 years

  3. OBD

    Phase I: Dose Escalation To determine Optimal Biological Dose (OBD) for ICP-192

    Measured: Up to 3 years

  4. RP2D

    Phase I: Dose Escalation To determine Recommended Phase 2 Dose (RP2D) for ICP-192

    Measured: Up to 3 years

  5. ORR

    Phase II: Dose Expansion Objective Response Rate

    Measured: Up to 3 years

Secondary outcomes (6)

  1. Peak concentration (Cmax)

    Phase I: Dose Escalation Peak concentration (Cmax)

    Measured: Up to 3 years

  2. AUC

    Phase I: Dose Escalation AUC

    Measured: Up to 3 years

  3. DCR

    Phase II: Dose Expansion disease control rate

    Measured: Up to 3 years

  4. DOR

    Phase II: Dose Expansion duration of response

    Measured: Up to 3 years

  5. PFS

    Phase II: Dose Expansion progression-free survival

    Measured: Up to 3 years

  6. OS

    Phase II: Dose Expansion overall survival

    Measured: Up to 3 years

Timeline

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

  1. First posted25 Sep 2020
  2. Study start1 Feb 2021
  3. Primary completion30 Nov 2023 (estimated)
  4. Study completion15 Apr 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
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04565275
Sponsor's protocol ID
ICP-CL-00303
Status last verified
Mar 2023
First submitted
1 Sep 2020
Last updated
14 Mar 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Drug ICP-192 in people with Advanced Solid Tumors and Urothelial Carcinoma, run by Beijing InnoCare Pharma Tech Co., Ltd. at 16 sites in 2 countries.

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

Who may be eligible to take part?

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 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, Australia. 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 Olivia Yang (+1 (609) 524-0684, olivia.yang@INNOCAREPHARMA.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Up to 3 years). The study lists 5 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 NCT04565275.

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 14 Mar 2023.

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