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

Sponsor
Hallym University Medical Center
Study ID
NCT05439993
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 1, 2022
Status verified
Jun 2022
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tepotinib plus paclitaxel arm

Primary Outcome Measure

Progression-free survival rate (PFSR) at 4 months [ Time Frame: PFSR at 4 months ]

Central Contacts

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