Actively Recruiting
A Study of VRN101099 in Patients With HER2-Positive Solid Tumors
Led by Voronoi, Inc · Updated on 2025-08-28
72
Participants Needed
1
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of VRN101099 in Patients With HER2-Positive Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older (19 years or older in Korea)
- Able to understand and sign informed consent
- Has at least one measurable or non-measurable lesion based on RECIST v1.1
- Confirmed HER2-positive or mutated cancer by immunohistochemistry or next-generation sequencing
- Medically confirmed to have no benefit from other standard therapies
- Life expectancy greater than 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at screening
- Women of childbearing potential and male partners agree to effective contraception during the study and for 6 months after treatment
You will not qualify if you...
- Confirmed HER2 exon 20 mutation
- Received anticancer drugs or treatments within 3 weeks before first study dose
- Previously treated with more than 6 systemic regimens for breast cancer or more than 3 for other solid tumors
- Unresolved adverse events from prior chemotherapy above grade 1 (except mild peripheral neuropathy or hair loss)
- Pregnant, breastfeeding, or planning pregnancy if of childbearing potential
- History of other active cancers within 3 years (except certain skin or cervical cancers)
- Abnormal blood counts or lab values below or above specified thresholds
- Uncontrolled hypercalcemia grade 2 or higher
- Prior high cumulative doses of certain chemotherapy drugs
- Current infections requiring systemic therapy (except controlled hepatitis B or C)
- Untreated or unstable hepatitis B or C
- Known HIV infection
- Received live vaccines within 4 weeks before first dose (except non-live flu or COVID-19 vaccines)
- Major surgery within 4 weeks before first dose, with recovery criteria
- Recent radiotherapy to large fields or vital organs
- Central nervous system metastases with progressive symptoms requiring high-dose steroids
- Other medical conditions needing high-dose steroids or past lung disease from steroids
- Significant cardiac disease or impaired heart function
- Unable to swallow capsules or with absorption disorders
- Known allergy to study drug components
- Fluid build-up requiring drainage therapies
- Eye diseases including retinal disorders or glaucoma
- Other significant medical or psychological conditions compromising study compliance or safety
- Investigator's judgment deeming patient inappropriate for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
Research Team
R
Rutu Dabhi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here