HER2-positive Solid TumorsPhase 1NCT06806982
A Study of VRN101099 in Patients With HER2-Positive Solid Tumors
A Phase 1 study testing VRN101099 in people with HER2-positive Solid Tumors, run by Voronoi, Inc at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Solid Tumors
- What is being tested?
- VRN101099
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteAustralia
- Study dates
- 17 Feb 2025to 31 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- In the opinion of the Investigator, is medically confirmed to derive no clinical benefit from other standard therapies.
- In the opinion of the Investigator, has a life expectancy > 6 months.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at Screening.
- Women of childbearing potential (WOCBP) who engage in heterosexual intercourse must agree to maintain effective contraception during the study and for up to 6 months after EOT; males whose sexual partners are WOCBP must also agree to maintain effective contraceptive method and should refrain from donating sperm during the study and for up to 6 months after EOT.
Who cannot join
- 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).
- Is a female who is pregnant, breastfeeding, or (among those of childbearing potential) planning to become pregnant.
- Has a history of other active malignancy within 3 years prior to Screening (note: patients with non-melanoma skin cancer, in situ melanoma, or in situ cervical cancer are permitted to be enrolled).
Show all 40Show fewer
- Has any of the following laboratory abnormalities during Screening:
- Hematology (note: transfusion or hematopoietic growth factor administration within 14 days prior to Screening test is not allowed):
- -White blood cell (WBC) count < 2.5 × 10 power 9/L
- -Absolute neutrophil count (ANC) < 1500/µL
- -Platelets < 100000/µL
- -Hemoglobin < 9.0 g/dL.
- Clinical chemistry:
- -Creatinine clearance < 60 mL/min according to the Cockroft-Gault equation
- -Total bilirubin > 1.5 × ULN
- -Aspartate aminotransferase/transaminase (AST or SGOT) > 2.5 × ULN (> 5 × ULN with liver metastases)
- - Alanine aminotransferase/transaminase (ALT or SGPT) > 2.5 × ULN (> 5 × ULN with liver metastases).
- Currently has uncontrolled NCI-CTCAE Grade ≥ 2 hypercalcemia.
- Has undergone prior treatment with a cumulative dose of doxorubicin of > 360 mg/meter square or previous treatment with another anthracycline with a cumulative dose equivalent to > 360 mg/meter square doxorubicin.
- Has a current infection (including tuberculosis infection, among others) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to the first dose of the IP (note: antiviral therapy is permitted for patients with hepatocellular carcinoma or chronic hepatitis B virus [HBV] or hepatitis C virus [HCV] infection).
- Has untreated chronic hepatitis B or is a chronic HBV carrier (undetectable HBV DNA) at Screening (note: patients who are inactive hepatitis B surface antigen [HBsAg] carriers or have treated and stable hepatitis B (undetectable HBV DNA) can be enrolled; patients with detectable HBsAg or detectable HBV DNA should be managed per treatment guidelines. Patients receiving antivirals at Screening should have been treated for > 2 weeks before the first dose of IP).
- Has active or chronic hepatitis C (note: patients with a negative HCV antibody test at Screening or positive HCV antibody test followed by a negative HCV RNA test at Screening are eligible; the HCV RNA test will only be performed for patients testing positive for HCV antibody. Patients receiving antivirals at Screening should have been treated for > 2 weeks before the first dose of IP).
- Has a known history of human immunodeficiency virus infection.
- Has received live vaccines within 4 weeks of the first dose of IP (note: the seasonal flu vaccines that does not contain live virus and coronavirus disease 2019 [COVID-19] vaccines are allowed).
- Has had major surgery within 4 weeks prior to the first dose of the IP. Patients should have recovered from the effects of major surgery or significant traumatic injury within 16 days prior to the first dose of the IP (note: major surgery is defined as one that cannot be performed with local anesthesia [i.e., general anesthesia, respiratory assistance, or regional anesthesia] or an open biopsy).
- Has received radiotherapy to a large field or including a vital organ within 14 days prior to the first dose of the IP (or 7 days prior to the first dose of the IP if a vital organ is not included).
- Has central nervous system (CNS) metastases or spinal cord compression that are associated with progressive neurological symptoms, or that require treatment with more than 10 mg daily of prednisone or equivalent doses of corticosteroids, or that have not been on stable steroid treatment for at least 2 weeks prior to first drug administration (note: CNS metastases that have been either previously treated and controlled, or are symptomatic, or are untreated and asymptomatic are permitted and, when evaluable, should be captured as target lesion).
- Has any other medical condition (with the exclusion of brain metastases as described above) requiring prednisone therapy of more than 10 mg daily or equivalent systemic steroid therapy (steroid replacement therapy for adrenal or pituitary insufficiency is permitted) or has received treatment with steroids for current or past non-infectious pneumonitis/interstitial lung disease.
- Has impaired cardiac function or clinically significant cardiac disease, including:
- New York Heart Association Grade 2 or higher congestive heart failure.
- Left ventricular ejection fraction < 50% within the last 6 months.
- Coronary artery bypass graft or vascular stent implantation.
- Any other uncontrolled cardiac condition such as unstable angina, arrhythmias requiring treatment, atrial fibrillation, or hypertension (systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg).
- Baseline prolongation of QT interval corrected for heart rate using Fridericia's method (QTcF) of > 470 msec for females or > 450 msec for males determined (by the average of 3 readings on triplicate 12-lead ECG) or history of long QTc syndrome (congenital or otherwise) or Torsade de Pointes.
- Is unable to swallow capsules or has intractable nausea, vomiting, or gastrointestinal diseases that interfere with proper absorption, or has any absorption disorders that may interfere with absorption of the IP.
- Has known or suspected allergy or anaphylaxis to any component of the IP.
- Has pleural effusion, ascites, or pericardial effusion requiring catheter drainage, peritoneal shunting, or Cell-free and concentrated Ascites Reinfusion Therapy (CART) (note: CART is not allowed within 2 weeks of the Screening visit).
- Has retinal vascular disorder, retinopathy, glaucoma, or retinal detachment.
- Any other clinically significant comorbidities, such as neurological or psychological disorders, which in the judgment of the Investigator, could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the subject to safety risks.
- For any other reason, as determined by the Investigator, the patient is deemed inappropriate to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010
Rasha Cosman, Dr
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of VRN101099 in Patients With HER2-Positive Solid Tumors
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.
Read the detailed description
This is an open-label study where eligible patients will receive VRN101099 capsules orally, once daily (QD) at the specified dose level, in repeated 21-day treatment cycles until disease progression (PD), death, loss to follow-up, start of another anticancer treatment, intolerable toxicity, withdrawal of consent, or study completion or closure (whichever occurs first).
Dose limiting toxicities (DLTs) will be monitored during the first cycle of treatment (i.e., 21 days of IP administration, Cycle 1).
The proposed VRN101099 dose levels are: 80 mg QD, 160 mg QD, 240 mg QD, 320 mg QD, 400 mg QD, and 480 mg QD.
Safety Monitoring committee will be setup for review DLTs and overall safety data. Border medical oncology in Australia will be using Omico for CaSP NGS screening participants to the study.
- Conditions
- HER2-positive Solid Tumors
- Being tested
- VRN101099
- Keywords
- HER2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRN101099Drug
Oral capsules
| Study group | Role | What they receive |
|---|---|---|
| VRN101099 | Experimental | 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 Receives: Drug: VRN101099 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate of Maximum tolerated dose (MTD) of VRN101099
This will be based on dose limiting toxicities (DLT) observed during the DLT evaluation period.
Measured: 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®).
Measured: Up to 2 years post first dose administration
Number of patients with changes in ECOG performance status from baseline following treatment with VRN101099
Measured: From Screening to 14 days post last dose
Number of patients with changes in physical/ophthalmic examination from baseline following treatment with VRN101099
Measured: From Screening to 14 days post last dose
Number of patients with changes in laboratory tests from baseline following treatment with VRN101099
Measured: From Screening to 14 days post last dose
Secondary outcomes (19)
Plasma PK of VRN101099 and Cycle1 Day 1- Cmax
Cmax- Maximum plasma concentration
Measured: 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.
Plasma PK of VRN101099 and Cycle1 Day 1-AUC0-last
AUC- Area under curve at time 0 to last
Measured: 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.
Plasma PK of VRN101099 and Cycle1 Day 1-AUC0-Inf
AUC- Area under curve at time 0 to Infinity
Measured: 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.
Plasma PK of VRN101099 and Cycle1 Day 1-Tmax
Tmax- Time for maximum concentration
Measured: 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.
Plasma PK of VRN101099 and Cycle1 Day 1- λz
λz- Terminal rate constant
Measured: 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.
Plasma PK of VRN101099 and Cycle1 Day 1- t1/2
T1/2- Terminal half life
Measured: 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.
Plasma PK of VRN101099 and Cycle1 Day 1- CL/F
CL/F- Apparent plasma clearance
Measured: 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.
Plasma PK of VRN101099 and Cycle1 Day 15- Cmax,ss
Cmax, ss- Maximum plasma concentration at steady state
Measured: 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.
Plasma PK of VRN101099 and Cycle1 Day 15- Cmin,ss
Cmin, ss- Minimum drug concentration at steady-state
Measured: 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.
Plasma PK of VRN101099 and Cycle1 Day 15- Tmax,ss
Tmax,ss Time for maximum concentration at steady-state
Measured: 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.
Plasma PK of VRN101099 and Cycle1 Day 15- AUC 0-last
AUC 0-last- Area under curve 0 to last
Measured: 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.
Plasma PK of VRN101099 and Cycle1 Day 15- swing
Measured: 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.
Plasma PK of VRN101099 and Cycle1 Day 15- Fluctuation
Measured: 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.
Plasma PK of VRN101099 and Cycle1 Day 15- Ctrough
Measured: 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.
To evaluate objective response rate (ORR)
The proportion of patients whose best overall response (BOR) is either confirmed complete responses (CR) or confirmed partial responses (PR).
Measured: Up to 2 years post first dose administration
Number of patients with disease Control Rate (DCR)
Percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents.
Measured: Up to 2 years post first dose administration
Number of patients with changes in duration of objective response (DOR)
The time from first documented disease control response (confirmed CR, confirmed PR, or confirmed SD) until the earlier of disease progression or death from any cause, whichever occurs first. This will only be applicable for patients who have a confirmed best overall response of CR, PR, or SD. Patients without the events (progressive disease or death) will be censored at the date of their last tumor assessment
Measured: Up to 2 years post first dose administration
To assess progression-free survival (PFS)
The time from start of study treatment to the earlier of either disease progression or death from any cause, whichever occurs first.
Measured: Up to 2 years post first dose administration
To assess time to progression (TTP)
TTP- Time between the starting time and local tumor progression per tumor treated.
Measured: Up to 2 years post first dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start17 Feb 2025
- Primary completion1 May 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Voronoi, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daekwon Kim, Study chair, Voronoi, Inc. Chief Executive Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806982
- Sponsor's protocol ID
- VRN101099_01
- Status last verified
- Aug 2025
- First submitted
- 6 Jan 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of VRN101099 in Patients With HER2-Positive Solid Tumors
- ClinicalTrials.gov ID
- NCT06806982
- Acronym / sponsor ID
- VRN101099_01
- Conditions
- HER2-positive Solid Tumors
- Keywords
- HER2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Voronoi, IncIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label study where eligible patients will receive VRN101099 capsules orally, once daily (QD) at the specified dose level, in repeated 21-day treatment cycles until disease progression (PD), death, loss to follow-up, start of another anticancer treatment, intolerable toxicity, withdrawal of consent, or study completion or closure (whichever occurs first).
Dose limiting toxicities (DLTs) will be monitored during the first cycle of treatment (i.e., 21 days of IP administration, Cycle 1).
The proposed VRN101099 dose levels are: 80 mg QD, 160 mg QD, 240 mg QD, 320 mg QD, 400 mg QD, and 480 mg QD.
Safety Monitoring committee will be setup for review DLTs and overall safety data. Border medical oncology in Australia will be using Omico for CaSP NGS screening participants to the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VRN101099 | Experimental | Drug: VRN101099VRN101099 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
- In the opinion of the Investigator, is medically confirmed to derive no clinical benefit from other standard therapies.
Key exclusion criteria (40 listed)
- 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).
- Is a female who is pregnant, breastfeeding, or (among those of childbearing potential) planning to become pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRN101099Oral capsules | Drug | VRN101099 |
Primary outcome
Estimate of Maximum tolerated dose (MTD) of VRN101099
Time frame: Up to 2 years post first dose administration
This will be based on dose limiting toxicities (DLT) observed during the DLT evaluation period.
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 administration
Number of patients with changes in ECOG performance status from baseline following treatment with VRN101099
Time frame: From Screening to 14 days post last dose
Number of patients with changes in physical/ophthalmic examination from baseline following treatment with VRN101099
Time frame: From Screening to 14 days post last dose
Number of patients with changes in laboratory tests from baseline following treatment with VRN101099
Time frame: From Screening to 14 days post last dose
19 secondary outcomes
Plasma PK of VRN101099 and Cycle1 Day 1- Cmax
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.
Plasma PK of VRN101099 and Cycle1 Day 1-AUC0-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.
Plasma PK of VRN101099 and Cycle1 Day 1-AUC0-Inf
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.
Plasma PK of VRN101099 and Cycle1 Day 1-Tmax
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.
Plasma PK of VRN101099 and Cycle1 Day 1- λz
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.
Plasma PK of VRN101099 and Cycle1 Day 1- t1/2
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.
Plasma PK of VRN101099 and Cycle1 Day 1- CL/F
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.
Plasma PK of VRN101099 and Cycle1 Day 15- Cmax,ss
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.
Plasma PK of VRN101099 and Cycle1 Day 15- Cmin,ss
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.
Plasma PK of VRN101099 and Cycle1 Day 15- Tmax,ss
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.
Plasma PK of VRN101099 and Cycle1 Day 15- AUC 0-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.
Plasma PK of VRN101099 and Cycle1 Day 15- swing
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.
Plasma PK of VRN101099 and Cycle1 Day 15- Fluctuation
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.
Plasma PK of VRN101099 and Cycle1 Day 15- Ctrough
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.
To evaluate objective response rate (ORR)
Time frame: Up to 2 years post first dose administration
Number of patients with disease Control Rate (DCR)
Time frame: Up to 2 years post first dose administration
Number of patients with changes in duration of objective response (DOR)
Time frame: Up to 2 years post first dose administration
To assess progression-free survival (PFS)
Time frame: Up to 2 years post first dose administration
To assess time to progression (TTP)
Time frame: Up to 2 years post first dose administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daekwon Kim study chair
Voronoi, Inc. Chief Executive Officer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VRN101099 in people with HER2-positive Solid Tumors, run by Voronoi, Inc at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rutu Dabhi (+1 201-515-9340, dabhirutu@voronoi.io), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimate of Maximum tolerated dose (MTD) of VRN101099 (time frame: Up to 2 years post first dose administration). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.