Bladder Urothelial CancerPhase 2NCT04492293
An Efficacy and Safety Study of ICP-192 in Subjects With Bladder Urothelial Cancer
A Phase 2 study testing ICP-192 in people with Bladder Urothelial Cancer, run by Beijing InnoCare Pharma Tech Co., Ltd. at 22 sites in China.
Trial summary
This is a phase 2, multicenter, single arm, open-lable study of ICP-192. The purpose of this study is to evaluate efficacy of ICP-192 in subjects with surgically unresectable or metastatic bladder urothelial cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Urothelial Cancer
- What is being tested?
- ICP-192
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 22 sitesChina
- Study dates
- 27 May 2020to 30 Jun 2025
- Phase
- Phase 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
Who may be able to join
- Signed the ICF and Age ≥ 18 years old, either sex.
- ECOG ≤ 1.
- Life expectancy of at least 3 months.
- Histologically confirmed unresectable or metastatic bladder urothelial cancinoma.
- At least one measurable lesion as the target lesion at screening assessed according to RECIST V1.1
Who cannot join
- Prior treatment with selective FGFR inhibitors or FGFR antibodies.
- Any corneal or retinal abnormalities that may result in an increased risk of ocular toxicity.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
China22 sites, 22 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100035
Zisong He
- Recruiting
The fifth Medical Center of People's Liberation Army General Hospital
Beijing, Beijing Municipality, 100071
Lijun Chen
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jun Guo, 010-88196348, guoj307@126.com
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Weiqing Han
- Recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan, 610000
Liao Hong
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Weiyang He
- Recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Liping Xie
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Shaoxing Zhu
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejing, 310014
Haiying Dong
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Hui Chen
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000
Chaozhao Liang
- Recruiting
The First Hospital of JiLin University
Jilin City, Jilin, 130021
Ziling Liu
- Recruiting
Shandong University Qilu Hospital
Jinan, Shandong, 250012
Benkang Shi
- Recruiting
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030
Li Yang
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Danfeng Xu
- Recruiting
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110801
Bin Hu
- Recruiting
The First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, 215006
Yuhua Huang
- Recruiting
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Xiaoming Cao
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Xin Yao
- Recruiting
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211
Hailong Hu
- Recruiting
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Xiaoping Zhang
- Recruiting
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Shaogang Wang
About this study
Official title: A Phase 2, Multicenter, Single Arm, Open-lable Study of ICP-192 in Subjects With Surgically Unresectable or Metastatic Bladder Urothelial Cancer With FGFR Genetic Aberrations.
This is a phase 2, multicenter, single arm, open-lable study of ICP-192. The purpose of this study is to evaluate efficacy of ICP-192 in subjects with surgically unresectable or metastatic bladder urothelial cancer.
Read the detailed description
bladder urothelial cancer
- Conditions
- Bladder Urothelial Cancer
- Being tested
- ICP-192
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICP-192Drug
ICP-192 is a white, round, uncoated table
| Study group | Role | What they receive |
|---|---|---|
| ICP-192 | Experimental | ICP-192 Receives: Drug: ICP-192 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective Response Rate
Measured: From the time of first dose until objective disease progression, an average of 6 months
Secondary outcomes (4)
DOR
Duration of response
Measured: From the time of first dose until objective disease progression, an average of 6 months
DCR
Disease Control Rate
Measured: From the time of first dose until objective disease progression, an average of 6 months
PFS
Progression Free Survival
Measured: From the time of first dose until objective disease progression, an average of 6 months
OS
Overall survival
Measured: From the time of first dose until objective disease progression, an average of 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start27 May 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Urothelial CancerStudies of the same condition, open and under way.
- More trials run by Beijing InnoCare Pharma Tech Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jun Guo, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492293
- Sponsor's protocol ID
- ICP-CL-00302
- Status last verified
- Feb 2024
- First submitted
- 23 Jul 2020
- Last updated
- 26 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Single Arm, Open-lable Study of ICP-192 in Subjects With Surgically Unresectable or Metastatic Bladder Urothelial Cancer With FGFR Genetic Aberrations.
- ClinicalTrials.gov ID
- NCT04492293
- Acronym / sponsor ID
- ICP-CL-00302
- Conditions
- Bladder Urothelial Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 May 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2, multicenter, single arm, open-lable study of ICP-192. The purpose of this study is to evaluate efficacy of ICP-192 in subjects with surgically unresectable or metastatic bladder urothelial cancer.
Detailed description
bladder urothelial cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICP-192 | Experimental | Drug: ICP-192ICP-192 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed the ICF and Age ≥ 18 years old, either sex.
- ECOG ≤ 1.
- Life expectancy of at least 3 months.
- Histologically confirmed unresectable or metastatic bladder urothelial cancinoma.
- At least one measurable lesion as the target lesion at screening assessed according to RECIST V1.1
Key exclusion criteria (2 listed)
- Prior treatment with selective FGFR inhibitors or FGFR antibodies.
- Any corneal or retinal abnormalities that may result in an increased risk of ocular toxicity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICP-192ICP-192 is a white, round, uncoated table | Drug | ICP-192 |
Primary outcome
ORR
Time frame: From the time of first dose until objective disease progression, an average of 6 months
Objective Response Rate
4 secondary outcomes
DOR
Time frame: From the time of first dose until objective disease progression, an average of 6 months
DCR
Time frame: From the time of first dose until objective disease progression, an average of 6 months
PFS
Time frame: From the time of first dose until objective disease progression, an average of 6 months
OS
Time frame: From the time of first dose until objective disease progression, an average of 1 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Guo principal investigator
Peking University Cancer Hospital & Institute
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ICP-192 in people with Bladder Urothelial Cancer, run by Beijing InnoCare Pharma Tech Co., Ltd. at 22 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 5 inclusion and 2 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 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 phase mean?
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 Jun Guo (010-88196348, guoj307@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: From the time of first dose until objective disease progression, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2024.