RecruitingPhase 1Phase 2NCT05439993

Tepotinib Plus Paclitaxel in MET Amplified or MET Exon 14 Alterated Gastric and GEJ Carcinoma

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


Sponsor

Hallym University Medical Center

Enrollment

42 participants

Start Date

Mar 1, 2022

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of tepotinib (a targeted drug blocking a cancer growth signal called MET) and paclitaxel (a standard chemotherapy) in patients with advanced stomach or gastroesophageal junction (GEJ) cancer that has a specific genetic change — MET amplification or MET exon 14 skipping mutation. These genetic changes make some cancers dependent on the MET pathway for growth. **You may be eligible if:** - You are 19 or older - You have advanced or metastatic stomach or GEJ cancer confirmed by biopsy - Your cancer has a MET amplification or MET exon 14 mutation (confirmed by testing) - Your cancer has progressed after first-line fluoropyrimidine-based chemotherapy **You may NOT be eligible if:** - Your cancer does not have the MET alteration required for the study - You have not yet tried first-line chemotherapy (for the Phase 2 portion) - Your health is too poor to tolerate the treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTepotinib plus paclitaxel

Paclitaxel 80mg/m2 on D1, 8, 15 tepotinib 250mg or 500mg daily on D1-28 Q 4weeks


Locations(1)

Hallym University Medical Center

Gyeonggi-do, South Korea

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NCT05439993


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