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

Required: MET amplification (copy number gain ≥3) (copy number gain ≥3)

MET amplified (copy number gain ≥3) ... identified in study customized targeted DNA deep sequencing (NGS by gastric cancer panel)

Required: MET exon 14 skipping mutation

MET exon 14 skipping mutation ... identified in study customized targeted DNA deep sequencing (NGS by gastric cancer panel)

Must have received: fluoropyrimidine-based chemotherapy — first-line

progressed after treatment with first-line fluoropyrimidine-based chemotherapy

Cannot have received: c-MET inhibitor

Any previous exposure to a c-MET inhibitor

Cannot have received: nitrosourea

Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment

Cannot have received: mitomycin C

Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment

Cannot have received: cytotoxic chemotherapy

Exception: within 14 days

Any cytotoxic chemotherapy from a previous treatment regimen within 14 days

Cannot have received: monoclonal antibody therapy

Exception: within 4 weeks

If monoclonal antibody therapy was given, the subject can be enrolled after four weeks after the last dose

Cannot have received: radiotherapy

Exception: wide field within 4 weeks or limited field for palliation within 2 weeks

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

Cannot have received: investigational drug

Exception: within 2 weeks and more than 5 x half-life

If the subject received an investigational drug from another clinical trial, the subject can be enrolled after 2 weeks of last administration and more than 5 x half-life of the investigational drug