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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 | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Elzovantinib is an investigational small molecule being developed for the treatment of advanced solid tumors, including metastatic solid tumors with MET gene alterations. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Elzovantinib is a kinase inhibitor, as indicated by its '-tinib' suffix. It is being studied in patients with genetic alterations in MET, a receptor tyrosine kinase involved in tumor growth and metastasis. The drug is designed to target MET-driven cancers.
Elzovantinib is being developed by Bristol-Myers Squibb Company, a global biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
Elzovantinib is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is active but not recruiting participants.
Elzovantinib is being evaluated in a single Phase 1 clinical trial with the identifier NCT03993873. This study is investigating the drug in patients with advanced NSCLC, gastric cancer, or solid tumors harboring genetic alterations in MET. The trial is active but not recruiting and has an enrollment of 95 participants.
Yes, elzovantinib is also known as TPX-0022. The drug is being studied under this alternative name in clinical trials, including the Phase 1 study NCT03993873, which evaluates TPX-0022 in patients with advanced solid tumors and MET gene alterations.