Advanced Solid TumorPhase 2NCT05372120
A Clinical Trial of ICP-192 in Treated Patients With Advanced Solid Tumors With FGF/FGFR Gene Alterations
A Phase 2 study testing ICP-192 in people with Advanced Solid Tumor, run by Beijing InnoCare Pharma Tech Co., Ltd. at 37 sites in China.
Trial summary
This is a phase II clinical trial in treated patients with advanced solid tumors with FGF/FGFR gene alterations. The purpose of this study is to evaluate the efficacy and safety of ICP-192. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- ICP-192
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 37 sitesChina
- Study dates
- 15 Dec 2021to 30 Jun 2024
- 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.
- Part 1 (head and neck cancer cohort): Patients with HNC cancer who have failed or cannot tolerate standard therapy, and with FGF/FGFR gene alteration
- Part 2 (other solid tumor cohorts): Patients with other solid tumor who have failed or cannot tolerate standard therapy, and with FGF/FGFR gene alteration
- At least one measurable lesion as the target lesion at screening assessed according to RECIST V1.1 criteria.
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.
- Previously or currently endocrine alterations affecting the regulation of calcium-phosphorus homeostasis. History and/or current evidence of extensive tissue calcification.
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
China37 sites, 36 recruiting
- Active, not recruiting
Cancer Hospital.Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Yan Sun
- Recruiting
The first affiliated hospital of bengbu medical college
Bengbu, Anhui, 233000
Jiang Hao
- Recruiting
The first hospital of jilin University
Changchun, Jilin, 130000
Jiujiang Cui
- Not yet recruiting
Xiangya Hospital Central South University
Changsha, Hunan, 410008
Liaoyang Shen
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Zhenyang Liu
- Recruiting
Hunan Tumor Hospital
Changsha, Hunan, 410013
Cuihong Jiang
- Recruiting
Sichuan Tumor Hospital
Chengdu, Sichuan, 610000
Shichuan Zhang
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610000
Nianyong Chen
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Shaojun Lin
- Recruiting
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong, 510000
Weidong Li
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Qingqing Cai
- Not yet recruiting
Shaoyifu Hospital of Zhejiang University Medical College
Hangzhou, Zhejiang, 310000
Hongming Pan
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000
Meiyu Fang
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014
Minghua Ge
- Not yet recruiting
Harbin Medical University cancer hospital
Harbin, Heilongjiang, 150081
Tongsen Zheng
- Recruiting
Anhui Provincal Cancer Hospital
Hefei, Anhui, 230031
Yifu He
- Recruiting
Shandong Provincial Institute of Cancer Prevention and Treatment
Jinan, Shandong, 250000
Man Hu
- Recruiting
QiLu Hospital of Shandong University
Jinan, Shandong, 250012
Yufeng Cheng
- Not yet recruiting
The First Affiliated Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Juntao Ran
Ting Wang
- Recruiting
Linyi Cancer Hospital
Linyi, Shandong, 276000
Jianhua Shi
- Recruiting
Nantong Cancer Hospital
Nantong, Jiangsu, 226361
Lei Yang
- Recruiting
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School Medicine
Shanghai, Shanghai Municipality, 20000
Guipei Zhu
- Not yet recruiting
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032
Tianshu Liu
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200135
Ye Guo
- Recruiting
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110801
Bin Hu
- Not yet recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 50000
Xiaoying Xue
- Recruiting
Tianjin medical university cancer institute&hospital
Tianjin, Tianjin Municipality, 300060
Peiguo Wang
- Recruiting
Union Hospital Toji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Kunyu Yang
- Not yet recruiting
Tongji Hospital Tongji Medical College of HUST
Wuhan, Hubei, 430030
Hu Guangyuan
- Recruiting
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, 214122
Yong Mao
- Recruiting
The First Affiliated Hospital of Xi An Jiaotong University
Xi’an, Shanxi, 710061
Shaoqiang Zhang
- Recruiting
Second People's Hospital of Yibin City
Yibin, Sichuan, 644000
Kaijian Lei
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Shundong Cang
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450003
Xingya Li
- Not yet recruiting
Henan Tumor Hospital
Zhengzhou, Henan, 450008
Suxia Luo
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Yanru Qin
About this study
Official title: A Phase II Clinical Trial to Evaluate the Efficacy and Safety of ICP-192 in Treated Patients With Advanced Solid Tumors With FGF/FGFR Gene Alterations
This is a phase II clinical trial in treated patients with advanced solid tumors with FGF/FGFR gene alterations. The purpose of this study is to evaluate the efficacy and safety of ICP-192.
- Conditions
- Advanced Solid Tumor
- 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 round, uncoated tablet, 4mg, 5mg. It is administered orally at the dose of 20 mg/day from day 1 to day 21 of each cycle until progression
| Study group | Role | What they receive |
|---|---|---|
| ICP-192 | Experimental | 20 mg once daily Receives: Drug: ICP-192 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
ORR based on assessment of confirmed Complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST).
Measured: From the time of first dose until objective disease progression, an average of 6 months
Secondary outcomes (2)
Duration of response (DOR)
DOR 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: From the time of first dose until objective disease progression, an average of 6 months
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: From the time of first dose until objective disease progression, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start15 Dec 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ye Guo, Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372120
- Sponsor's protocol ID
- ICP-CL-00304
- Status last verified
- Dec 2022
- First submitted
- 8 May 2022
- Last updated
- 4 Jan 2023
- 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial to Evaluate the Efficacy and Safety of ICP-192 in Treated Patients With Advanced Solid Tumors With FGF/FGFR Gene Alterations
- ClinicalTrials.gov ID
- NCT05372120
- Acronym / sponsor ID
- ICP-CL-00304
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 12 May 2022 (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 II clinical trial in treated patients with advanced solid tumors with FGF/FGFR gene alterations. The purpose of this study is to evaluate the efficacy and safety of ICP-192.
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-19220 mg once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed the ICF and Age ≥ 18 years old, either sex.
- ECOG ≤ 1.
- Life expectancy of at least 3 months.
- Part 1 (head and neck cancer cohort): Patients with HNC cancer who have failed or cannot tolerate standard therapy, and with FGF/FGFR gene alteration
- Part 2 (other solid tumor cohorts): Patients with other solid tumor who have failed or cannot tolerate standard therapy, and with FGF/FGFR gene alteration
Key exclusion criteria (3 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.
- Previously or currently endocrine alterations affecting the regulation of calcium-phosphorus homeostasis. History and/or current evidence of extensive tissue calcification.
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 round, uncoated tablet, 4mg, 5mg. It is administered orally at the dose of 20 mg/day from day 1 to day 21 of each cycle until progression | Drug | ICP-192 |
Primary outcome
Objective response rate (ORR)
Time frame: From the time of first dose until objective disease progression, an average of 6 months
ORR based on assessment of confirmed Complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST).
2 secondary outcomes
Duration of response (DOR)
Time frame: From the time of first dose until objective disease progression, an average of 6 months
Disease Control Rate (DCR)
Time frame: From the time of first dose until objective disease progression, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Derived from this study: PubMed 42542997Xue 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.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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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.
Ye Guo principal investigator
Shanghai East Hospital
37 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 Advanced Solid Tumor, run by Beijing InnoCare Pharma Tech Co., Ltd. at 37 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 6 inclusion and 3 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 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 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 Ye Guo (13501678472, pattrickguo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (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?
On the ClinicalTrials.gov record for NCT05372120, 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 4 Jan 2023.