Gastric CancerPhase 1/2NCT05439993
Tepotinib Plus Paclitaxel in MET Amplified or MET Exon 14 Alterated Gastric and GEJ Carcinoma
A Phase 1/2 study testing Tepotinib plus paclitaxel in people with Gastric Cancer and Gastroesophageal-junction Cancer, run by Hallym University Medical Center at 1 site in South Korea.
Trial summary
Purpose of this study is to define the maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) of paclitaxel and tepotinib combination therapy in patients with advanced tumors and to evaluate the efficacy of paclitaxel and tepotinib combination treatment as second-line therapy in patients with advanced… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Cancer, Gastroesophageal-junction Cancer
- What is being tested?
- Tepotinib plus paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2022to 30 Jun 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have the willingness to sign a written informed consent document prior to any study specific precedures
- Age ≥ 19 years of male and female
- At each phase of the trial, subjects who meet the following requirements in the appropriate phase will be enrolled.
- Phase 1b: Subjects with a histologically confirmed metastatic solid tumor that have progressed after treatment with approved therapies or for which there is no standard effective therapy available.
- Phase 2b: Subjects with histologically confirmed locally advanced or metastatic gastric and gastroesophageal carcinoma that have progressed after treatment with first-line fluoropyrimidine-based chemotherapy, with MET amplified (copy number gain ≥3) or MET exon 14 skipping mutation in the archival or fresh tumor tissue specimen identified in study customized targeted DNA deep sequencing (NGS by gastric cancer panel). If the subject received adjuvant chemotherapy after curative gastric resection and lymph node dissection, adjuvant chemotherapy is considered to be the first-line palliative chemotherapy if the disease recurred during adjuvant chemotherapy or within 6 months after the completion of adjuvant chemotherapy.
- Patients must have measurable disease based on RECIST 1.1 (Phase 2 part only) Measurable disease will not be required for enrollment in the phase1b part. Patients with evaluable lesion only (without measurable lesion) can be enrolled in the phase 1b part.
- ECOG performance status 0-1
- Patients must have adequate organ and marrow function as defined below:
Who cannot join
- Active central nervous system (CNS) lesions (ie, those with radiologically unstable or symptomatic brain lesions). For those who receive radiation or surgical treatment, the subject can be enrolled if the subject is maintained without evidence of CNS disease progression for more than 4 weeks. However, patients with a leptomeningeal metastasis are excluded.
- Treatment with any of the following:
- Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment
- Any cytotoxic chemotherapy from a previous treatment regimen within 14 days. If the subject received an investigational drug from another clinical trial, the subejct can be enrolled after 2 weeks of last administration and more than 5 x half-life of the investigational drug. If monoclonal antibody therapy was given, the subject can be enrolled after four weeks after the last does.
- Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment. If acute symptoms of radiation have fully resolved, the extent and timing of radiotherapy for eligibility can be discussed between the local investigator and principal investigator.
- Any previous exposure to a c-MET inhibitor
Show all 21Show fewer
- History of allogeneic bone marrow transplantation or organ transplantation
- History of another primary cancer (excluding gastric cancer):
- Clinically significant cardiovascular disease including but not limited to:
- Acute coronary syndome within the 6 months prior to the initiation of study drug (including myocardial infarction or unstable angina, Coronary Artery Bypass Graft surgery, percuatneous coronary intervention and stenting)
- Current heart failure or past history of heart failure
- Left ventricle ejection fraction (LVEF) < 50%; if there is no past history of heart failure, screening with echocardiography to confirm EF is not required.
- Current or past history of clinically significant cardiac arrhythmia (eg, complete left bundle branch block, third degree heart block)
- Any risk factors that prolong QTc or increase the probability of arrhythmia, including medication (eg: heart failure, hypokalemia, congenital long QT syndrome, history of Torsades de Pointes)
- Persistent uncontrolled hypertension as defined by: systolic >180 mmHg or diastolic >100 mmHg despite medical treatment
- Seropositivity of HIV or known active hepatitis B and/or active hepatitis C infection. Hepatitis B carriers may be enrolled if prophylactic use of an antiviral agent with minimal interaction with CYP3A4 is administered to inhibit HBV activation (eg. Entecavir, adefovir)
- Impairment of gastrointestinal function or gastrointestinal disorders (eg. untreated ulcerative disorders; uncontrolled nausea, vomiting, or diarrhea; absorption disorder syndrome; small bowel resection; ileostomy). Patients with ileostomcy will not allowed to be enrolled, but patients with colostomy can be enrolled to this study.
- As judged by the Investigator, all other symptoms and associated disease for which the investigator determined that participation in this study is contraindicated (e.g. Infection/inflammation; severe liver dysfunction; bilateral diffuse interstitial lung disease; uncontrolled renal disease; unstable heart and lung disease; hemorrhagic disease; intestinal obstruction; unable to swallow oral pills; social and psychological problems, etc)
- Pregnant or lactating women. Pregnancy is defined as the state from conception confirmed by HCG clinical laboratory test to termination of pregnancy.
- Medical, psychiatric, cognitive, or other conditions that may interfere with the ability of the subject to understand the subject information, provide the informed consent, follow the protocol process, or complete the clinical trial
- Hypersensitivity to paclitaxel
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hallym University Medical Center
Gyeonggi-do
Bum Jun Kim, Dr, 82-10-7140-6753, getwisdom1025@gmail.com
About this study
Official title: A Phase 1b/2 Study of Tepotinib in Combination With Paclitaxel in Patients With MET Amplified or MET Exon 14 Alterated Advanced Gastric and Gastroesophageal Junction Carcinoma
Purpose of this study is to define the maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) of paclitaxel and tepotinib combination therapy in patients with advanced tumors and to evaluate the efficacy of paclitaxel and tepotinib combination treatment as second-line therapy in patients with advanced gastric and gastroesophageal junction carcinomas (AGC/GEJCs) with MET amplification or MET exon 14 alterations. This study is devided into Phase 1b and Phase 2 study.
- Conditions
- Gastric Cancer, Gastroesophageal-junction Cancer
- Being tested
- Tepotinib plus paclitaxel
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tepotinib plus paclitaxelDrug
Paclitaxel 80mg/m2 on D1, 8, 15 tepotinib 250mg or 500mg daily on D1-28 Q 4weeks
| Study group | Role | What they receive |
|---|---|---|
| Tepotinib plus paclitaxel arm | Experimental | Not described Receives: Drug: Tepotinib plus paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival rate (PFSR) at 4 months
Measured: PFSR at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start1 Mar 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (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 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hallym University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zang, Dae Young, Hallym University Medical Center
- Investigators
- Dae Young Zang, Dr, Principal investigator, Hally University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439993
- Sponsor's protocol ID
- Tepotinib in GC
- Status last verified
- Jun 2022
- First submitted
- 27 Jun 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanchez Garcia D, Grau Mirete B, Rodriguez Paya P, Ferrandez-Arias A, Borregon-Rivilla M, Lazaro-Sanchez AD, Benitez-Fuentes JD. Adding Docetaxel to Tepotinib to Overcome Oligoprogression in MET Exon 14 Skipping-Mutated NSCLC When Local Therapy Is Unfeasible: A Case Report. Case Rep Oncol Med. 2025 Aug 19;2025:4483379. doi: 10.1155/crom/4483379. eCollection 2025.
PubMed 40880848
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Study of Tepotinib in Combination With Paclitaxel in Patients With MET Amplified or MET Exon 14 Alterated Advanced Gastric and Gastroesophageal Junction Carcinoma
- ClinicalTrials.gov ID
- NCT05439993
- Acronym / sponsor ID
- Tepotinib in GC
- Conditions
- Gastric Cancer, Gastroesophageal-junction Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Hallym University Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 30 Jun 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.
Purpose of this study is to define the maximal tolerated dose (MTD) and recommended phase 2 dose (RP2D) of paclitaxel and tepotinib combination therapy in patients with advanced tumors and to evaluate the efficacy of paclitaxel and tepotinib combination treatment as second-line therapy in patients with advanced gastric and gastroesophageal junction carcinomas (AGC/GEJCs) with MET amplification or MET exon 14 alterations. This study is devided into Phase 1b and Phase 2 study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tepotinib plus paclitaxel arm | Experimental | Drug: Tepotinib plus paclitaxel |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Have the willingness to sign a written informed consent document prior to any study specific precedures
- Age ≥ 19 years of male and female
- At each phase of the trial, subjects who meet the following requirements in the appropriate phase will be enrolled.
- Patients must have measurable disease based on RECIST 1.1 (Phase 2 part only) Measurable disease will not be required for enrollment in the phase1b part. Patients with evaluable lesion only (without measurable lesion) can be enrolled in the phase 1b part.
- ECOG performance status 0-1
Key exclusion criteria (21 listed)
- Active central nervous system (CNS) lesions (ie, those with radiologically unstable or symptomatic brain lesions). For those who receive radiation or surgical treatment, the subject can be enrolled if the subject is maintained without evidence of CNS disease progression for more than 4 weeks. However, patients with a leptomeningeal metastasis are excluded.
- Treatment with any of the following:
- History of allogeneic bone marrow transplantation or organ transplantation
- History of another primary cancer (excluding gastric cancer):
- Clinically significant cardiovascular disease including but not limited to:
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 |
|---|---|---|
| Tepotinib plus paclitaxelPaclitaxel 80mg/m2 on D1, 8, 15 tepotinib 250mg or 500mg daily on D1-28 Q 4weeks | Drug | Tepotinib plus paclitaxel arm |
Primary outcome
Progression-free survival rate (PFSR) at 4 months
Time frame: PFSR at 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Derived from this study: PubMed 40880848Sanchez Garcia D, Grau Mirete B, Rodriguez Paya P, Ferrandez-Arias A, Borregon-Rivilla M, Lazaro-Sanchez AD, Benitez-Fuentes JD. Adding Docetaxel to Tepotinib to Overcome Oligoprogression in MET Exon 14 Skipping-Mutated NSCLC When Local Therapy Is Unfeasible: A Case Report. Case Rep Oncol Med. 2025 Aug 19;2025:4483379. doi: 10.1155/crom/4483379. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
Dae Young Zang, Dr principal investigator
Hally University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tepotinib plus paclitaxel in people with Gastric Cancer and Gastroesophageal-junction Cancer, run by Hallym University Medical Center at 1 site in South Korea.
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 21 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 5 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 1 site in South Korea. 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 Bum Jun Kim, Dr (82-10-7140-6753, getwisdom1025@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival rate (PFSR) at 4 months (time frame: PFSR at 4 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 NCT05439993, 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 5 Jul 2022.