Active Not RecruitingPhase 1NCT03993873
Official study title

Study of TPX-0022 in Patients With Advanced NSCLC, Gastric Cancer or Solid Tumors Harboring Genetic Alterations in MET

Study summary

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)

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedelzovantinib (TPX-0022)

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · MET · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 1, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 1

Interventional

Where is it offered?24 U.S. locations

Locations may change over time.

Who runs it?Turning Point Therapeutics, Inc.

Study sponsor

01
Study overview

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)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

Requirements people may need to meetInclusion 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 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.

Reasons someone may not be able to joinExclusion criteria

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.

04
Study sites

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.

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