Skip to content
DataLookout
Start free
Menu

NCT06806982

A Study of VRN101099 in Patients With HER2-Positive Solid Tumors

StatusRecruiting
PhasePhase 1
Primary completion (estimated)

At risk: Primary completion moved 10 months later.

See at-risk trials from Voronoi, Inc

Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from May 1, 2026 to Mar 1, 2027 Show 4 more changesShow less
    • Eligibility criteria expanded, about 24 words
    • Primary endpoints: details revised at 1 of 5 entries
    • Secondary endpoints: details revised at 3 of 19 entries
    • Site details revised
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Feb 11, 2025 to Feb 17, 2025
    • Study description expanded, about 17 words
    • Site details revised
    • Study title shortened, about 2 words
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Estimate of Maximum tolerated dose (MTD) of VRN101099
Timeframe: Up to 2 years post first dose administration
Number of participants with Adverse events (AEs) and Serious Adverse events (SAE) as assessed by Medical Dictionary for Regulatory Activities (MedDRA®).
Timeframe: Up to 2 years post first dose administration
Number of patients with changes in ECOG performance status from baseline following treatment with VRN101099
Timeframe: From Screening to 14 days post last dose
Number of patients with changes in physical/ophthalmic examination from baseline following treatment with VRN101099
Timeframe: From Screening to 14 days post last dose
Number of patients with changes in laboratory tests from baseline following treatment with VRN101099
Timeframe: From Screening to 14 days post last dose

Secondary (19)

Plasma PK of VRN101099 and Cycle1 Day 1- Cmax
Plasma PK of VRN101099 and Cycle1 Day 1-AUC0-last
Plasma PK of VRN101099 and Cycle1 Day 1-AUC0-Inf
Plasma PK of VRN101099 and Cycle1 Day 1-Tmax
Plasma PK of VRN101099 and Cycle1 Day 1- λz
Show 14 moreShow less
Plasma PK of VRN101099 and Cycle1 Day 1- t1/2
Plasma PK of VRN101099 and Cycle1 Day 1- CL/F
Plasma PK of VRN101099 and Cycle1 Day 15- Cmax,ss
Plasma PK of VRN101099 and Cycle1 Day 15- Cmin,ss
Plasma PK of VRN101099 and Cycle1 Day 15- Tmax,ss
Plasma PK of VRN101099 and Cycle1 Day 15- AUC 0-last
Plasma PK of VRN101099 and Cycle1 Day 15- swing
Plasma PK of VRN101099 and Cycle1 Day 15- Fluctuation
Plasma PK of VRN101099 and Cycle1 Day 15- Ctrough
To evaluate objective response rate (ORR)
Number of patients with disease Control Rate (DCR)
Number of patients with changes in duration of objective response (DOR)
To assess progression-free survival (PFS)
To assess time to progression (TTP)

Arms and interventions

VRN101099Experimental

VRN101099 capsules will be administered orally as monotherapy once daily over 21-day cycles Dose and frequency of dosing: The planned doses for dose escalation are 80 mg, 160 mg, 240 mg, 320 mg, 400 mg, and 480 mg once daily. Dosage form- Oral capsules

Drugs: VRN101099

Sites

1 site in 1 country

  • St Vincent's Hospital SydneyDarlinghurst, New South Wales, Australia