Gastric CancerPhase 2NCT06206278
Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma
A Phase 2 study testing Infigratinib in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by LianBio LLC at 30 sites in China.
Trial summary
This is a multicenter, open-label, single arm phase II study to evaluate the efficacy and safety of Infigratinib in patients with locally advanced or metastatic GC or GEJ patient with FGFR2 gene amplification, who have failed at least 2 lines of previous standard systemic treatment . Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Infigratinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 30 sitesChina
- Study dates
- 19 Oct 2023to 31 May 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older
- Histologically or cytologically confirmed locally advanced or metastatic gastric adenocarcinoma, or gastroesophageal junction adenocarcinoma.
- Failed at least 2 lines of prior systemic therapy
- Willing to undergo tumor biopsy or provide FFPE samples for central lab testing.
- At least one measurable tumor lesion by RECIST v1.1
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1.
- Life expectancy ≥3 months.
- Willing to participate in this study and sign informed consent form, able to read and understand the study, follow the procedures.
Who cannot join
- History of other primary malignancies within 3 years except adequately treated in situ carcinoma of the cervix or non-melanoma carcinoma of the skin or any other curatively treated malignancy that is not expected to require treatment for recurrence during the study.
- Previous or current treatment of a mitogen-activated protein kinase (MAPK-MEK) or selective FGFR inhibitor.
- Any known hypersensitivity to infigratinib or its excipients.
- History and/or current evidence of extensive tissue calcification.
- Current evidence of endocrine alterations of calcium/phosphate homeostasis.
- Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral infigratinib (such as, ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).14. Laboratory abnormality as defined in protocol.
- Considered unsuitable to participate in the study by Investigator
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
China30 sites
Affiliated Hospital of Hebei University
Baoding, Hebei, 071030
Beijing Cancer Center
Beijing, Beijing Municipality, 100142
Jilin Cancer Hospital
Changchun, Jilin, 130012
Hunan Provincial People's Hospital
Changsha, Hunan, 410002
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Sichuan Cancer Hospital
Chengdu, Sichuan, 610042
Dongguan City People's Hospital
Dongguan, Guangdong, 523059
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, 541199
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310013
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230031
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601
Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250013
Shandong Provincial Cancer Hosptial
Jinan, Shandong, 250117
Yunnan Cancer Hospital
Kunming, Yunnan, 650118
The Second Hospital Lanzhou University
Lanzhou, Gansu, 730030
Liuzhou People's Hospital
Liuzhou, Guangxi, 545006
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
The First Hospital of China Medical University
Shenyang, Liaoning, 110002
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013
Tianjin Medical University Cancer Institute&Hospital
Tianjin, Tianjin Municipality, 300060
Tongji Hospital, Tongji Medical College of HUST
Wuhan, Hubei, 430030
Hubei Cancer Hospital
Wuhan, Hubei, 430079
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: A Phase II, Multicenter, Open-Label, Single Arm Study of Oral Infigratinib Monotherapy in Patients With Locally Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma, Who Harboring FGFR2 Gene Amplification
This is a multicenter, open-label, single arm phase II study to evaluate the efficacy and safety of Infigratinib in patients with locally advanced or metastatic GC or GEJ patient with FGFR2 gene amplification, who have failed at least 2 lines of previous standard systemic treatment .
- Being tested
- Infigratinib
- Keywords
- Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, FGFR2
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfigratinibDrug
Also called BGJ398, BBP-831
Infigratinib is a selective ATP-competitive inhibitor of fibroblast growth factor receptor (FGFR) 1-3 that inhibits FGFR downstream signaling and proliferation in human cancer cell lines with FGFR genetic alterations, significantly inhibiting the growth of several types of cancers driven by FGFR amplification, fusion and mutation.
| Study group | Role | What they receive |
|---|---|---|
| Infigratinib | Experimental | Infigratinib 125 mg orally daily, 3 weeks on, 1 week off. . In patients with mild liver function abnormalities or mild renal impairment, the starting dose is 100 mg. Receives: Drug: Infigratinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
ORR: the proportion of patients with confirmed complete response (CR) or partial response (PR), assessed by the independent review committee (IRC) according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1.
Measured: Week9/17/25/33 and every 12 weeks after (up to 2 years)
Duration of response (DoR)
DoR: the duration from the first evaluation as CR or PR to the first evaluation as progressive disease (PD) or death of any cause, per RECIST v1.1 assessed by investigator (INV) and IRC.
Measured: Week9/17/25/33 and every 12 weeks after (up to 2 years)
Disease control rate (DCR)
DCR: the proportion of patients whose overall response is confirmed to be CR or PR or stable disease (SD) per RECIST v1.1, assessed by INV and IRC.
Measured: Week9/17/25/33 and every 12 weeks after (up to 2 years)
Investigator evaluated ORR
the proportion of patients with confirmed CR or PR assessed by INV according to RECIST v1.1
Measured: Week9/17/25/33 and every 12 weeks after (up to 2 years)
Progression-free survival (PFS)
the duration from the first date of treatment to the date of progression or death due to any cause, assessed by INV and IRC
Measured: Week9/17/25/33 and every 12 weeks after (up to 2 years)
Overall survival (OS)
from the first date of Infigratinib treatment until date of death.
Measured: from the first date of Infigratinib treatment until date of death.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start19 Oct 2023
- Primary completion31 May 2024
- Study completion31 May 2024
Why it stopped: Business Reason
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- LianBio LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206278
- Sponsor's protocol ID
- LB1001-203
- Status last verified
- Aug 2024
- First submitted
- 29 Nov 2023
- Last updated
- 14 Aug 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 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Open-Label, Single Arm Study of Oral Infigratinib Monotherapy in Patients With Locally Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma, Who Harboring FGFR2 Gene Amplification
- ClinicalTrials.gov ID
- NCT06206278
- Acronym / sponsor ID
- LB1001-203
- Keywords
- Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, FGFR2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Reason
- Enrolment
- 6 participants (actual)
- Lead sponsor
- LianBio LLCIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 16 Jan 2024 (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 multicenter, open-label, single arm phase II study to evaluate the efficacy and safety of Infigratinib in patients with locally advanced or metastatic GC or GEJ patient with FGFR2 gene amplification, who have failed at least 2 lines of previous standard systemic treatment .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infigratinib | Experimental | Drug: InfigratinibInfigratinib 125 mg orally daily, 3 weeks on, 1 week off. . In patients with mild liver function abnormalities or mild renal impairment, the starting dose is 100 mg. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years and older
- Histologically or cytologically confirmed locally advanced or metastatic gastric adenocarcinoma, or gastroesophageal junction adenocarcinoma.
- Failed at least 2 lines of prior systemic therapy
- Willing to undergo tumor biopsy or provide FFPE samples for central lab testing.
- At least one measurable tumor lesion by RECIST v1.1
Key exclusion criteria (7 listed)
- History of other primary malignancies within 3 years except adequately treated in situ carcinoma of the cervix or non-melanoma carcinoma of the skin or any other curatively treated malignancy that is not expected to require treatment for recurrence during the study.
- Previous or current treatment of a mitogen-activated protein kinase (MAPK-MEK) or selective FGFR inhibitor.
- Any known hypersensitivity to infigratinib or its excipients.
- History and/or current evidence of extensive tissue calcification.
- Current evidence of endocrine alterations of calcium/phosphate homeostasis.
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 |
|---|---|---|
| InfigratinibAlso: BGJ398, BBP-831Infigratinib is a selective ATP-competitive inhibitor of fibroblast growth factor receptor (FGFR) 1-3 that inhibits FGFR downstream signaling and proliferation in human cancer cell lines with FGFR genetic alterations, significantly inhibiting the growth of several types of cancers driven by FGFR amplification, fusion and mutation. | Drug | Infigratinib |
Primary outcome
Objective response rate (ORR)
Time frame: Week9/17/25/33 and every 12 weeks after (up to 2 years)
ORR: the proportion of patients with confirmed complete response (CR) or partial response (PR), assessed by the independent review committee (IRC) according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1.
Duration of response (DoR)
Time frame: Week9/17/25/33 and every 12 weeks after (up to 2 years)
DoR: the duration from the first evaluation as CR or PR to the first evaluation as progressive disease (PD) or death of any cause, per RECIST v1.1 assessed by investigator (INV) and IRC.
Disease control rate (DCR)
Time frame: Week9/17/25/33 and every 12 weeks after (up to 2 years)
DCR: the proportion of patients whose overall response is confirmed to be CR or PR or stable disease (SD) per RECIST v1.1, assessed by INV and IRC.
Investigator evaluated ORR
Time frame: Week9/17/25/33 and every 12 weeks after (up to 2 years)
the proportion of patients with confirmed CR or PR assessed by INV according to RECIST v1.1
Progression-free survival (PFS)
Time frame: Week9/17/25/33 and every 12 weeks after (up to 2 years)
the duration from the first date of treatment to the date of progression or death due to any cause, assessed by INV and IRC
Overall survival (OS)
Time frame: from the first date of Infigratinib treatment until date of death.
from the first date of Infigratinib treatment until date of death.
Results and safety
The study was stopped early (reason given: Business Reason). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
30 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 Infigratinib in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by LianBio LLC at 30 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 8 inclusion and 7 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: stopped early, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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?
The study was stopped early (reason given: Business Reason). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Week9/17/25/33 and every 12 weeks after (up to 2 years)). The study lists 6 primary outcomes in all. 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 14 Aug 2024.