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A Study of VRN110755 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer

ConditionEGFR-Mutant Non-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVoronoi, Inc

About this trial

This first-in-human, Phase 1/2, multicenter, open-label, non-randomized study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of VRN110755, a highly selective oral epidermal growth factor receptor (EGFR) inhibitor, in patients with EGFR-mutant non-small cell lung cancer (NSCLC).

The study includes a Phase 1a dose-escalation portion, a Phase 1b dose-expansion portion, and a Phase 2 evaluation. The study is designed to determine the maximum tolerated dose and recommended Phase 2 dose of VRN110755 and to evaluate preliminary and confirmatory antitumor activity in patients with EGFR-mutant NSCLC, including patients with acquired resistance following EGFR tyrosine kinase inhibitor therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 years or older (19 years or older in the Republic of Korea).

Able to understand, sign, and provide written informed consent.

Histologically or cytologically confirmed advanced, metastatic, or recurrent predominantly nonsquamous non-small cell lung cancer (NSCLC) with a documented epidermal growth factor receptor (EGFR) mutation.

At least one measurable extracranial lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

Disqualifiers

Received an investigational anticancer therapy within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment.

Unresolved side effects from previous anticancer therapy greater than Grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), except for Grade 2 peripheral neuropathy or alopecia.

Pregnant or breastfeeding, or planning to become pregnant during the study.

NSCLC with an EGFR or HER2 exon 20 insertion mutation.

Trial design

Design model

Sequential

Treatments tested in this trial

  • VRN110755

    Drug

    VRN110755 is an investigational highly selective oral EGFR inhibitor supplied as capsules for oral administration. The drug is designed to target activating EGFR mutations and selected resistance mutations, including C797S, in patients with EGFR-mutant NSCLC.

Treatment groups

315 Participants
are divided into 5 treatment groups
Group A: Phase 1a Dose EscalationExperimental treatment 1 intervention
Group B: Phase 1b Cohort AExperimental treatment 1 intervention
Group C: Phase 1b Cohort BExperimental treatment 1 intervention
Group D: Phase 1b Cohort CExperimental treatment 1 intervention
Group E: Phase 1b Cohort DExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Estimate of Maximum Tolerated Dose (MTD) of VRN110755

This will be based on dose-limiting toxicities (DLTs) observed during the DLT evaluation period.

Time frame
28 days
2

Number of participants with dose-limiting toxicities (DLTs) following treatment with VRN110755

Dose-limiting toxicities will be assessed according to protocol-defined DLT criteria during the DLT evaluation period.

Time frame
28 days
3

Number of participants experiencing treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events leading to discontinuation

Time frame
From first dose until end of study (up to approximately 6 years)
4

Number of participants with changes in vital signs from baseline following treatment with VRN110755

Vital signs include blood pressure, pulse rate, respiratory rate, body temperature, and oxygen saturation.

Time frame
From baseline through End of Treatment (up to approximately 6 years)

Secondary outcomes

1

Plasma PK of VRN110755 - Maximum Plasma Concentration (Cmax)

Maximum observed plasma concentration of VRN110755.

Time frame
Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.
2

Plasma PK of VRN110755 - Minimum Plasma Concentration (Cmin)

Minimum observed plasma concentration of VRN110755.

Time frame
Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.
3

Plasma PK of VRN110755 - Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast)

Area under the plasma concentration-time curve from time zero to the last measurable concentration of VRN110755.

Time frame
Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.
4

Plasma PK of VRN110755 - Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUCτ)

Area under the plasma concentration-time curve over the dosing interval at steady state for VRN110755.

Time frame
Predose and up to 24 hours postdose on protocol-specified pharmacokinetic sampling days.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Voronoi, Inc

Lead sponsor

Source ClinicalTrials.gov
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