Study of TPX-0022 in Patients With Advanced NSCLC, Gastric Cancer or Solid Tumors Harboring Genetic Alterations in MET
A phase 1/2, first-in-human, open-label study of the safety, tolerability, PK, and efficacy of the novel MET/CSF1R/SRC inhibitor TPX-0022 in adult subjects with advanced or metastatic NSCLC, Gastric Cancer, or solid tumors harboring genetic alterations in MET. (SHIELD-I)
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 1, 2025 · Source: ClinicalTrials.gov
The study is underway but is not accepting new participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Turning Point Therapeutics, Inc.
- Interventions being studied
- Drug: elzovantinib (TPX-0022)
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
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 biopsy or tissue, solid tumors with MET fusions or oncogenic MET mutations or MET amplified other than GI/NSCLC. 3. ECOG performance status ≤ 1. 4. Existence of measurable or evaluable disease (according to Response evaluation criteria in solid tumors \[RECIST v1.1\] criteria). 5. Subjects with asymptomatic primary CNS tumors or brain metastases are eligible for the study if they meet protocol specified criteria. 6. Adequate organ function. 7. Life expectancy ≥ 12 weeks.
1. Locally advanced solid tumor that is a candidate for curative treatment through radical surgery and/or radiotherapy, or chemotherapy. 2. Presence or history of any other primary malignancy within the past 3 years other than a history of adequately treated basal or squamous cell carcinoma of the skin, or any adequately treated in situ carcinoma. 3. Major surgery within four weeks of the start of therapy. 4. Additional
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Local Institution - 2102La Jolla, California
- Local Institution - 2108Orange, California
- Local Institution - 2105Denver, Colorado
- Local Institution - 2111Chicago, Illinois
- Local Institution - 2107Boston, Massachusetts
- Local Institution - 2109Boston, Massachusetts
- Local Institution - 2106Ann Arbor, Michigan
- Local Institution - 2113Detroit, Michigan
- Local Institution - 2103St Louis, Missouri
- Local Institution - 2104Toledo, Ohio
- Local Institution - 2101Houston, Texas
- Local Institution - 2112Fairfax, Virginia
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 1, 2025. Always confirm current availability with the study team.