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New treatment option for HER2-positive Solid Tumors
Official title A Study of VRN101099 in Patients With HER2-Positive Solid Tumors
ClinicalTrials.gov ID: NCT06806982
What this study is testing
What is VRN101099?
VRN101099 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for her2-positive solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Has confirmed HER2-positive or mutated cancer as determined by immunohistochemistry (IHC) staining (IHC 1+, 2+, 3+) or next-generation sequencing...
- In the opinion of the Investigator, is medically confirmed to derive no clinical benefit from other standard therapies.
You likely can't join if
- 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...
- Has been previously treated with systemic anticancer treatment of more than 6 regimens for breast cancer or 3 regimens for other solid tumors (note...
- Has any AEs from previous chemotherapy that have not recovered to National Cancer Institute Common Terminology Criteria for Adverse Events...
- 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...
See the full eligibility criteria
Who can 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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).
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- For any other reason, as determined by the Investigator, the patient is deemed inappropriate to participate in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Darlinghurst, New South Wales, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Darlinghurst, New South Wales, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.