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Advanced Solid TumorPhase 1SHIELD-1NCT03993873

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

A Phase 1 study testing elzovantinib (TPX-0022) in people with Advanced Solid Tumor and Metastatic Solid Tumors, run by Turning Point Therapeutics, Inc. at 24 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
elzovantinib (TPX-0022)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
24 sitesin 5 countries
Study dates
5 Sep 2019to 3 Mar 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 (or age ≥ 20 as required by local regulation).
  • 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.
  • ECOG performance status ≤ 1.
  • Existence of measurable or evaluable disease (according to Response evaluation criteria in solid tumors [RECIST v1.1] criteria).
  • Subjects with asymptomatic primary CNS tumors or brain metastases are eligible for the study if they meet protocol specified criteria.
  • Adequate organ function.
  • Life expectancy ≥ 12 weeks.

Who cannot join

  • Locally advanced solid tumor that is a candidate for curative treatment through radical surgery and/or radiotherapy, or chemotherapy.
  • 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.
  • Major surgery within four weeks of the start of therapy.
  • Additional exclusion criteria for subjects with NSCLC with MET alterations: known oncogene mutations (eg, ALK, ROS1, KRAS, EGFR, etc.) for which there are approved therapies.
  • Additional exclusion criteria for subjects with HCC with MET alterations: liver dysfunction greater than Child-Pugh Class A.
  • Clinically significant cardiovascular disease (either active or within six months before enrollment): myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association Classification Class ≥ II), cerebrovascular accident or transient ischemic attack, symptomatic bradycardia, requirement for anti-arrhythmic medication. Ongoing cardiac dysrhythmias of CTCAE version 5.0 grade ≥ 2.
Show all 12Show fewer
  • Any of the following cardiac criteria:
  • Mean resting corrected QT interval (ECG interval measured from the onset of the QRS complex to the end of the T wave) for heart rate (QTc) > 470 msec obtained from three ECGs, using the screening clinic ECG machine-derived QTc value
  • Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval > 250 msec)
  • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong the QT interval
  • Known clinically significant active infections not controlled with systemic treatment (bacterial, fungal, viral including HIV positivity).
  • Peripheral neuropathy ≥ Grade 2.

Trial locations and contacts

24 sites in 5 countries.

24 sites in 5 countries

United States12 sites

  • Local Institution - 2106

    Ann Arbor, Michigan, 48109

  • Local Institution - 2107

    Boston, Massachusetts, 02114

  • Local Institution - 2109

    Boston, Massachusetts, 02215

  • Local Institution - 2111

    Chicago, Illinois, 60637

  • Local Institution - 2105

    Denver, Colorado, 80218

  • Local Institution - 2113

    Detroit, Michigan, 48202

  • Local Institution - 2112

    Fairfax, Virginia, 22031

  • Local Institution - 2101

    Houston, Texas, 77030-4009

  • Local Institution - 2102

    La Jolla, California, 92093

  • Local Institution - 2108

    Orange, California, 92868

  • Local Institution - 2103

    St Louis, Missouri, 63110

  • Local Institution - 2104

    Toledo, Ohio, 43614

Other trials in United States

France4 sites

  • Local Institution - 4202

    La Tronche, Auvergne-Rhône-Alpes, 38700

  • Local Institution - 4201

    Lyon, 69008

  • Local Institution - 4203

    Saint-Mandé, Val-de-Marne, 94160

  • Local Institution - 4204

    Villejuif, Val-de-Marne, 94805

Other trials in France

Spain4 sites

  • Local Institution - 4104

    Madrid, 28036

  • Local Institution - 4103

    Madrid, 28040

  • Local Institution - 4101

    Madrid, 28050

  • Local Institution - 4102

    Pamplona, 31008

Other trials in Spain

South Korea3 sites

  • Local Institution - 6301

    Seoul, Seoul-teukbyeolsi [Seoul], 06351

  • Local Institution - 6303

    Seoul, 03080

  • Local Institution - 6302

    Seoul, 120-752

Other trials in South Korea

North Korea1 site

  • Local Institution - 6304

    Seoul, 05505

About this study

Official title: A Phase 1/2 of Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of TPX-0022 in Adult Subjects With Locally Advanced or Metastatic 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)

Read the detailed description

Dose Escalation: To evaluate the overall safety profile of TPX-0022, single and multiple dose PK profiles and preliminary efficacy in adults subjects with advanced solid tumors harboring genetic alterations in MET.

Dose Expansion: To evaluate the preliminary efficacy and overall safety profile of TPX-0022 at the RP2D in defined cohorts of adult subjects in NSCLC, Gastric Cancer and advanced solid tumors harboring genetic alterations in MET.

Being tested
elzovantinib (TPX-0022)
Keywords
Non Small Cell Lung, Non Small Cell Lung Cancer, Non-small cell lung cancer, NSCLC, TPX-0022, EGFR wild-type (wt), advanced non-small cell lung cancer, advanced/metastatic disease, Non-small cell lung carcinoma (NSCLC), treatment of lung cancer after first metastasis, treatment of gastric cancer after first metastasis, treatment of hepatocellular cancer after first metastasis, lung cancer, lung adenocarcinoma, Non small cell lung carcinoma, MET exon 14 deletion, MET exon 14 skipping, MET exon 14 mutation, MET mutation, MET amplification
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis, Lung Neoplasms, Adenocarcinoma of Lung, Stomach Neoplasms, Liver Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • elzovantinib (TPX-0022)Drug

    Oral elzovantinib (TPX-0022) capsules

Study groups in NCT03993873
Study groupRoleWhat they receive
Phase 1 elzovantinibExperimentalThe 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
Receives: Drug: elzovantinib (TPX-0022)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of first cycle dose-limiting toxicities (DLTs) of elzovantinib

    Evaluate the safety and tolerability of elzovantinib

    Measured: Within 28 days of the first elzovantinib dose for each patient

  2. Define the Recommended Phase 2 Dose

    Determine the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of elzovantinib

    Measured: Approximately 48 months

Secondary outcomes (12)

  1. Adverse events (AEs)

    Evaluate the overall safety profile of elzovantinib

    Measured: Approximately 48 months

  2. Cmax (maximum plasma concentration) of elzovantinib

    Evaluate the maximum plasma concentration of elzovantinib

    Measured: Up to 72 hours post-dose

  3. AUC (area under plasma concentration time curve) of elzovantinib

    Evaluate the AUC of elzovantinib

    Measured: Up to 72 hours post-dose

  4. Cmax (maximum plasma concentration) of TPX-0022 under different food intake conditions

    Determine the effect of food (specifically, a high-fat, high-calorie meal) on the single-dose PK (Cmax) of elzovantinib at the RP2D

    Measured: Up to 72 hours post-dose

  5. AUC (area under plasma concentration time curve) of elzovantinib under different food intake conditions

    Determine the effect of food (specifically, a high-fat, high-calorie meal) on the single-dose PK (AUC) of elzovantinib at the RP2D

    Measured: Up to 72 hours post-dose

  6. Preliminary Objective Response Rate (ORR)

    Determine the preliminary objective response rate (ORR) by Blinded Independent Central Review (BICR) of elzovantinib

    Measured: Approximately 48 months

  7. Clinical benefit rate (CBR)

    Determine the CBR of elzovantinib

    Measured: Approximately 48 months

  8. Time to response (TTR)

    Determine the TTR of elzovantinib

    Measured: Approximately 48 months

  9. Duration of Response (DOR)

    Determine the DOR of elzovantinib

    Measured: Approximately 48 months

  10. Progression free survival (PFS)

    Determine the PFS of elzovantinib

    Measured: Approximately 48 months

  11. Intracranial tumor response

    Determine the intracranial tumor response in subjects with measurable brain metastases, as determined by BICR

    Measured: Approximately 48 months

  12. Overall survival (OS)

    Determine efficacy and safety of elzovantinib

    Measured: Approximately 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2019
  2. Study start5 Sep 2019
  3. Primary completion8 Jan 2024
  4. Study completion3 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03993873
Sponsor's protocol ID
CA177-1036
Other IDs
CA177-1036, TPX-0022-01
Acronym
SHIELD-1
Status last verified
Sep 2025
First submitted
13 Jun 2019
Last updated
1 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing elzovantinib (TPX-0022) in people with Advanced Solid Tumor and Metastatic Solid Tumors, run by Turning Point Therapeutics, Inc. at 24 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, France, Spain, South Korea, North Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of first cycle dose-limiting toxicities (DLTs) of elzovantinib (time frame: Within 28 days of the first elzovantinib dose for each patient). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03993873.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.

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