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Tyrosine Kinase Inhibitor

VERT-002 for Solid Tumors

Nashville, TN

Phase 1 & 2

Recruiting

Research Sponsored by Pierre Fabre Medicament

Eligibility Criteria Checklist

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

Must have

Histological confirmation of relapsed and/or refractory locally advanced or metastatic solid tumor for which no standard of care treatment is available

Histological confirmation of locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) Stage IIIB/C or IV not eligible for curative intent surgery, chemoradiation or radiotherapy

Must not have

Major surgical procedure within 14 days of the first dose of VERT-002

Live attenuated vaccine within 28 days prior to the first dose of VERT-002

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to study the safety and effectiveness of VERT-002 in people with solid tumors, including non-small cell lung cancer, to determine the best and safest dose to use."

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Who is the study for?

This trial is for individuals with advanced or widespread solid tumors, including non-small cell lung cancer, that have specific genetic changes known as MET alterations. Details on who can join are not fully provided.Check my eligibility

What is being tested?

The study is testing VERT-002 to find a safe and effective dose and see how well it works in treating certain types of cancers with genetic alterations.See study design

What are the potential side effects?

Specific side effects of VERT-002 are not listed, but common ones for cancer treatments may include fatigue, nausea, skin reactions, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has returned or didn't respond to treatment and has spread, with no standard treatment left.

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My lung cancer is advanced and cannot be treated with surgery or radiation aimed at a cure.

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I have had no more than 2 previous systemic treatments.

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I am fully active or have some restrictions but can still care for myself.

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My cancer has a specific genetic change related to MET.

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Exclusion Criteria

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

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I have not had major surgery within the last 14 days.

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I have not received a live vaccine in the last 28 days.

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I haven't taken any experimental drugs recently.

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I am allergic to VERT-002 or similar drugs.

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I do not have uncontrolled brain metastases or worsening spinal cord compression.

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I am not pregnant or breastfeeding.

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I have a history of lung conditions that needed steroid treatment.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: VERT-002Experimental Treatment1 Intervention

Part 1: Dose escalation (Phase Ia): VERT-002 will be administered via intravenous (IV) infusion every 2 weeks. 4 provisional doses are planned. An alternative regimen may be tested informed by the emerging data Part 2a: Preliminary Activity Assessment (Phase Ib): One dose \& schedule selected from Part 1 Part 2b: Dose range optimization (Phase Ib): 2 or 3 doses \& schedule selected from Part 1: From the lower limit \[Optimal Biologically Active Dose (OBD)\] \& upper limit \[Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) if MTD is not reached\] Part 3: Dose Expansion at RP2D (Phase II): To be defined later on

0 / 12Eligibility criteria met