A Study of VRN101099 in Patients With HER2-Positive Solid Tumors
ConditionHER2-positive Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorVoronoi, Inc
About this trial
This FIH open-label study aims to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor effect of VRN101099 in patients with HER2-positive solid tumors for whom no standard therapies are available.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥ 18 years (patients in Korea must be aged ≥ 19 years).
Able to comprehend and willing to sign an informed consent form and to abide by the study requirements and restrictions.
Has at least 1 evaluable lesion (measurable or non-measurable) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (note: metastatic brain lesions will also be assessed using the Response Assessment in Neuro-Oncology - Brain Metastases [RANO-BM] as an exploratory objective).
Has confirmed HER2-positive or mutated cancer as determined by immunohistochemistry (IHC) staining (IHC 1+, 2+, 3+) or next-generation sequencing (NGS) of tissue or circulating tumor DNA (i.e., evaluation of HER2 copy numbers or mutations) (note: documentation of HER2 status is required prior to Screening;
Disqualifiers
Has a confirmed HER2 exon 20 mutation (in the documented NGS test result).
Received any IP, cytotoxic chemotherapy, or other anticancer drugs from a previous treatment regimen or clinical study within 3 weeks of the first dose of the study IP (note: Rescreening will be permitted after a washout period of 3 weeks).
Has been previously treated with systemic anticancer treatment of more than 6 regimens for breast cancer or 3 regimens for other solid tumors (note: local administration of rituximab is allowed but intrathecal methotrexate or concurrent chemoradiotherapy is regarded as systemic therapy).
Has any AEs from previous chemotherapy that have not recovered to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade ≤ 1 (note: Grade ≤ 2 peripheral neuropathy or hair loss is acceptable).
Trial design
Design model
Single group
Treatments tested in this trial
VRN101099
DrugOral capsules
Treatment groups
72 Participants
are divided into 1 treatment groupGroup A: VRN101099Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Estimate of Maximum tolerated dose (MTD) of VRN101099
This will be based on dose limiting toxicities (DLT) observed during the DLT evaluation period.
Time frame
Up to 2 years post first dose administration2
Number of participants with Adverse events (AEs) and Serious Adverse events (SAE) as assessed by Medical Dictionary for Regulatory Activities (MedDRA®).
Time frame
Up to 2 years post first dose administration3
Number of patients with changes in ECOG performance status from baseline following treatment with VRN101099
Time frame
From Screening to 14 days post last dose4
Number of patients with changes in physical/ophthalmic examination from baseline following treatment with VRN101099
Time frame
From Screening to 14 days post last doseSecondary outcomes
1
Plasma PK of VRN101099 and Cycle1 Day 1- Cmax
Cmax- Maximum plasma concentration
Time frame
Blood sampling from pre dose to 24 hours post dose administration on Cycle1 Day 1 and Day 15 (C1D1, C1D15) and pre dose on Cycle 1 Day 8 (C1D8). Each Cycle-28 days. Additionally, on Predose on Cycle 2 Day 1, Cycle 2 Day 8 and Day 1 of subsequent cycles.2
Plasma PK of VRN101099 and Cycle1 Day 1-AUC0-last
AUC- Area under curve at time 0 to last
Time frame
Blood sampling from pre dose to 24 hours post dose administration on Cycle1 Day 1 and Day 15 (C1D1, C1D15) and pre dose on Cycle 1 Day 8 (C1D8). Each Cycle-28 days. Additionally, on Predose on Cycle 2 Day 1, Cycle 2 Day 8 and Day 1 of subsequent cycles.3
Plasma PK of VRN101099 and Cycle1 Day 1-AUC0-Inf
AUC- Area under curve at time 0 to Infinity
Time frame
Blood sampling from pre dose to 24 hours post dose administration on Cycle1 Day 1 and Day 15 (C1D1, C1D15) and pre dose on Cycle 1 Day 8 (C1D8). Each Cycle-28 days. Additionally, on Predose on Cycle 2 Day 1, Cycle 2 Day 8 and Day 1 of subsequent cycles.4
Plasma PK of VRN101099 and Cycle1 Day 1-Tmax
Tmax- Time for maximum concentration
Time frame
Blood sampling from pre dose to 24 hours post dose administration on Cycle1 Day 1 and Day 15 (C1D1, C1D15) and pre dose on Cycle 1 Day 8 (C1D8). Each Cycle-28 days. Additionally, on Predose on Cycle 2 Day 1, Cycle 2 Day 8 and Day 1 of subsequent cycles.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov