Study of TPX-0022 in Patients With Advanced NSCLC, Gastric Cancer or Solid Tumors Harboring Genetic Alterations in MET
NCT ID: NCT03993873
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
95 participants
INTERVENTIONAL
2019-09-05
2027-03-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phase 1 elzovantinib
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
elzovantinib (TPX-0022)
Oral elzovantinib (TPX-0022) capsules
Interventions
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elzovantinib (TPX-0022)
Oral elzovantinib (TPX-0022) capsules
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
6. 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.
7. 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
8. Known clinically significant active infections not controlled with systemic treatment (bacterial, fungal, viral including HIV positivity).
9. Peripheral neuropathy ≥ Grade 2.
18 Years
ALL
No
Sponsors
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Turning Point Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 2102
La Jolla, California, United States
Local Institution - 2108
Orange, California, United States
Local Institution - 2105
Denver, Colorado, United States
Local Institution - 2111
Chicago, Illinois, United States
Local Institution - 2107
Boston, Massachusetts, United States
Local Institution - 2109
Boston, Massachusetts, United States
Local Institution - 2106
Ann Arbor, Michigan, United States
Local Institution - 2113
Detroit, Michigan, United States
Local Institution - 2103
St Louis, Missouri, United States
Local Institution - 2104
Toledo, Ohio, United States
Local Institution - 2101
Houston, Texas, United States
Local Institution - 2112
Fairfax, Virginia, United States
Local Institution - 4202
La Tronche, Auvergne-Rhône-Alpes, France
Local Institution - 4203
Saint-Mandé, Val-de-Marne, France
Local Institution - 4204
Villejuif, Val-de-Marne, France
Local Institution - 4201
Lyon, , France
Local Institution - 6304
Seoul, , North Korea
Local Institution - 6301
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 6303
Seoul, , South Korea
Local Institution - 6302
Seoul, , South Korea
Local Institution - 4104
Madrid, , Spain
Local Institution - 4103
Madrid, , Spain
Local Institution - 4101
Madrid, , Spain
Local Institution - 4102
Pamplona, , Spain
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CA177-1036
Identifier Type: OTHER
Identifier Source: secondary_id
TPX-0022-01
Identifier Type: OTHER
Identifier Source: secondary_id
CA177-1036
Identifier Type: -
Identifier Source: org_study_id
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