Elzovantinib for Solid Tumors
(SHIELD-1 Trial)

Recruiting in Palo Alto (17 mi)

+52 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Turning Point Therapeutics, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?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)

Eligibility Criteria

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.

Inclusion Criteria

My cancer has a specific MET mutation or amplification.

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

Life expectancy ≥ 12 weeks

+4 more

Exclusion Criteria

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

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

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

+6 more

Participant Groups

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.

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