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Multi-kinase inhibitor

Elzovantinib for Solid Tumors (SHIELD-1 Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Turning Point Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Peripheral neuropathy ≥ Grade 2

Additional exclusion criteria for subjects with HCC with MET alterations: liver dysfunction greater than Child-Pugh Class A

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 48 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer drug to see if it is safe and effective. The study will first test increasing doses of the drug to see what the safe range is. Then, the study will expand to test the drug's effectiveness against different types of cancer.

Who is the study for?

Adults over 18 with advanced or metastatic lung (NSCLC), stomach cancer, or solid tumors with specific genetic changes in MET. They must have a good performance status, measurable disease, and adequate organ function. Not for those with certain heart conditions, other recent cancers, severe infections, significant neuropathy or who are candidates for curative surgery/radiotherapy.

What is being tested?

The trial is testing TPX-0022 (elzovantinib), a new drug targeting MET/CSF1R/SRC proteins in tumors. It's an early-stage study to check safety and how well it works against different types of advanced cancers that have alterations in the MET gene.

What are the potential side effects?

While not specified here, drugs like TPX-0022 may cause side effects such as fatigue, nausea, diarrhea; liver enzyme elevation; blood count changes; and possibly affect heart rhythm due to its mechanism on cellular signaling pathways.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has a specific MET mutation or amplification.

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I am fully active and can carry on all pre-disease activities without restriction.

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I am at least 18 years old, or 20 if required by local laws.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have moderate to severe numbness, pain, or weakness in my hands or feet.

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My liver function is better than or equal to Child-Pugh Class A.

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My heart may not be functioning properly, or I have a history of heart issues.

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My solid tumor can potentially be cured with surgery, radiation, or chemotherapy.

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I have had serious heart problems or strokes within the last 6 months.

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I do not have any uncontrolled infections.

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My NSCLC does not have mutations like ALK, ROS1, KRAS, EGFR that can be treated with approved drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Define the Recommended Phase 2 Dose

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

Secondary study objectives

AUC (area under plasma concentration time curve) of elzovantinib

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

Adverse events (AEs)

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Phase 1 elzovantinibExperimental Treatment1 Intervention

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

0 / 10Eligibility criteria met