← Back to Search

Multi-kinase inhibitor

Elzovantinib for Solid Tumors (SHIELD-1 Trial)

Q: What is the primary goal of this research endeavor?

The principal outcome of this trial is to ascertain the Recommended Phase 2 Dose within 28 days from when a patient first takes TPX-0022. Secondary objectives include establishing Clinical benefit rate (CBR) for TPX-0022, appraising Cmax in relation to varying food intake conditions and preliminarily assessing Objective Response Rates (ORR) using Blinded Independent Central Review (BICR).

Q: What is the enrollment capacity for this medical experiment?

A total of 330 individuals matching the predetermined criteria are necessary to complete this medical experiment. The trial is being conducted in multiple locations, including Dana Farber <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Institute and University of <a href="https://www.withpower.com/clinical-trials/texas">Texas</a> MD Anderson Cancer Center.

Q: Does the eligibility window remain open for participation in this experiment?

Yes, the information hosted on clinicaltrials.gov confirms that recruitment is in progress for this medical trial. It was initially posted online on August 20th 2019 and last revised on March 30th 2022, with 330 patients expected to participate at 9 distinct sites.

Q: How many venues are supporting this clinical examination?

This research is actively recruiting patients from Dana Farber <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Institute in Boston, the University of <a href="https://www.withpower.com/clinical-trials/texas">Texas</a> MD Anderson Cancer Center located in Houston, and additionally at the University of <a href="https://www.withpower.com/clinical-trials/california">California</a> Irvine Chao Family Comprehensive Cancer Centre situated in Irvine. There are a further 9 sites available nationally.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 48 months

Awards & highlights

SHIELD-1 Trial 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.Check my eligibility

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.See study design

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.

SHIELD-1 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My cancer has a specific MET mutation or amplification.

Select...

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

Select...

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

SHIELD-1 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Define the Recommended Phase 2 Dose

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

Secondary outcome measures

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

SHIELD-1 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Turning Point Therapeutics, Inc.Lead Sponsor

9 Previous Clinical Trials

722 Total Patients Enrolled

Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb

1,506 Previous Clinical Trials

3,369,350 Total Patients Enrolled

Zach Zimmerman, MD, PhDStudy DirectorTurning Point Therapeutics, Inc.

Media Library

TPX-0022 (Multi-kinase inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03993873 — Phase 1 & 2

Mutations Research Study Groups: Phase 1 elzovantinib

Mutations Clinical Trial 2023: TPX-0022 Highlights & Side Effects. Trial Name: NCT03993873 — Phase 1 & 2

TPX-0022 (Multi-kinase inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03993873 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary goal of this research endeavor?

"The principal outcome of this trial is to ascertain the Recommended Phase 2 Dose within 28 days from when a patient first takes TPX-0022. Secondary objectives include establishing Clinical benefit rate (CBR) for TPX-0022, appraising Cmax in relation to varying food intake conditions and preliminarily assessing Objective Response Rates (ORR) using Blinded Independent Central Review (BICR)."

Answered by AI

What is the enrollment capacity for this medical experiment?

"A total of 330 individuals matching the predetermined criteria are necessary to complete this medical experiment. The trial is being conducted in multiple locations, including Dana Farber Cancer Institute and University of Texas MD Anderson Cancer Center."

Answered by AI

Does the eligibility window remain open for participation in this experiment?

"Yes, the information hosted on clinicaltrials.gov confirms that recruitment is in progress for this medical trial. It was initially posted online on August 20th 2019 and last revised on March 30th 2022, with 330 patients expected to participate at 9 distinct sites."

Answered by AI

How many venues are supporting this clinical examination?

"This research is actively recruiting patients from Dana Farber Cancer Institute in Boston, the University of Texas MD Anderson Cancer Center located in Houston, and additionally at the University of California Irvine Chao Family Comprehensive Cancer Centre situated in Irvine. There are a further 9 sites available nationally."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "Study of TPX-0022 in Patients With Advanced NSCLC, Gastric Cancer or Solid Tumors Harboring Genetic Alterations in MET". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03993873.

All > Lung Adenocarcinoma > Gastric Cancer