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Also known as elzovantinib (TPX-0022)
elzovantinib · 1 trial · 3 indications
Evaluate the safety and tolerability of elzovantinib
Determine the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of elzovantinib
| Arm | Type | Description |
|---|---|---|
| Phase 1 elzovantinib | EXPERIMENTAL | The dose-escalation part of the study will determine the safety, tolerability, MTD, and RP2D of elzovantinib. The dose-expansion part of the study will determine the safety, tolerability, PK, and preliminary efficacy in specific cohorts. Dose expansion cohorts: Cohort I (NSCLC, METΔex14, treatment Naive) Enrollment Closed; Cohort II (NSCLC with METΔex14, MET therapy pre-treated) Enrollment closed; Cohort III (MET amplified NSCLC, GCN≥10); Cohort IV (MET amplified GI cancer GC/GEJ, CRC/HCC, GCN≥10); Cohort V (NSCLC or GI MET amplified, GCN≥5 and \< 10); Cohort VI (Solid tumors with MET fusions, or oncogenic MET mutations or MET amplified other than GI/NSCLC |
| Name | Type | Description |
|---|---|---|
| elzovantinib (TPX-0022) | DRUG | Oral elzovantinib (TPX-0022) capsules |
Inclusion Criteria: 1. Age ≥ 18 (or age ≥ 20 as required by local regulation). 2. Histological or cytological confirmation of advanced/metastatic MET exon 14 skipping mutation (METΔex14) NSCLC, MET amplified NSCLC, or MET amplified gastric cancers as determined by FISH, qPCR or NGS by local liquid ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Elzovantinib is an investigational small molecule being studied for advanced solid tumors, including metastatic solid tumors and cancers harboring MET gene alterations. Its clinical program includes patients with advanced non-small cell lung cancer and gastric cancer. It is not approved for any indication and remains in clinical development.
Elzovantinib is a kinase inhibitor, a small molecule in the -tinib class. It is designed to target genetic alterations in MET, which is why the clinical program selects patients whose tumors harbor MET gene alterations. Targeting MET is intended to interfere with signaling that drives tumor growth in these biomarker-selected cancers.
Elzovantinib is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is the sponsor of the drug's clinical program in advanced solid tumors, including non-small cell lung cancer and gastric cancer.
Elzovantinib is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. The Phase 1 program is evaluating the drug in patients with advanced solid tumors, including those with MET gene alterations.
Elzovantinib is being studied in one active clinical trial, NCT03993873, titled Study of TPX-0022 in Patients With Advanced NSCLC, Gastric Cancer or Solid Tumors Harboring Genetic Alterations in MET. The trial is Phase 1, active but not recruiting, and has enrolled 95 patients across the United States, France, Spain, North Korea, and South Korea.
Yes, elzovantinib is also known as TPX-0022. The two names refer to the same investigational kinase inhibitor, and the clinical trial listing uses the TPX-0022 designation. Readers searching for either name will find the same Phase 1 program in advanced solid tumors with MET gene alterations.