BridgeMD
New treatment option for Advanced Solid Tumor
Official title A Study of AP402 in HER2-Positive Patients With Locally or Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06669975
What this study is testing
What is AP402 (Part 1 Dose esclation)?
AP402 (Part 1 Dose esclation) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumor.
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 is a Phase 1/2, multi-regional, multi-center, open-label, first-in-human (FIH), dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary clinical activity of AP402 in HER2-positive patients with locally or advanced solid tumors.
- Phase 2: a mid-size study of how well it works
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
- Patients with histologically or cytologically proven locally unresectable advanced or metastatic HER2-postive solid tumors which no standard therapy...
- Adult patients aged ≥ 18 years at the time of signing informed consent form (ICF).
- Written informed consent by the patients or the patient's legally authorized representative prior to Screening.
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at study enrollment and an estimated life expectancy of at least...
- Disease must have at least 1 measurable (long diameter ≥ 1cm) lesion by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Tumor...
You likely can't join if
- Patients who have received concurrent antitumor treatment or investigational products within 28 days or 5 half-lives before the start of IP...
- Patients who had received CD137-targeted therapeutics within 28 days or 5 half-lives before the start of IP, whichever comes earlier.
- Patients who had major surgery within 28 days before the start of IP (excluding prior diagnostic biopsy).
- Patients who had continuance of toxicities due to prior antitumor agents that have not resolved to Grade ≤ 1 per NCI CTCAE version 5.0, except...
- Patients with a history of immune mediated AE of any grade that resulted in discontinuation of prior immunotherapy.
- Patients with previous malignant disease other than the target malignancy to be investigated in this study within the last 2 years with the exception...
See the full eligibility criteria
Who can join
- Patients with histologically or cytologically proven locally unresectable advanced or metastatic HER2-postive solid tumors which no standard therapy suitable.
- Adult patients aged ≥ 18 years at the time of signing informed consent form (ICF).
- Written informed consent by the patients or the patient's legally authorized representative prior to Screening.
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at study enrollment and an estimated life expectancy of at least 3 months.
- Disease must have at least 1 measurable (long diameter ≥ 1cm) lesion by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Tumor lesions situated in a previously irradiated area are not considered...
- Patients with adequate organ function defined by the following:
- Absolute neutrophil count ≥ 1.5 × 109 /L.
- Platelet count ≥ 100 × 109 /L.
- Hemoglobin ≥ 9 g/dL.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN or \< 5 × ULN if hepatic metastases present.
- Serum total bilirubin ≤ 1.5 × ULN (or \< 3 × ULN for patients with Gilbert's syndrome).
- Alkaline phosphatase ≤ 2.5 × ULN or \< 5 × ULN if bone metastases present.
- Prothrombin time ≤ 1.5 × ULN.
- International normalized ratio (INR) ≤ 2.0 or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. Exception: INR 2 to ≤ 3 is acceptable for patients on a stable dose of anticoagulants.
- Estimated creatinine clearance \> 45 mL/min according to the Cockcroft Gault formula.
- Albumin ≥ 28 g/L NOTE: Patients must not have required blood transfusions or growth factor support ≤ 14 days before sample collection at Screening.
- Females must not be pregnant or lactating, and must use acceptable, highly effective double contraception from Screening until 90 days after study completion, including the Follow-up period. Effective forms of...
- Males must be surgically sterile (\>30 days since vasectomy with no viable sperm), or if engaged in sexual relations with a WOCBP, either his partner must be surgically sterile (eg, tubal occlusion, hysterectomy...
What rules you out
- Patients who have received concurrent antitumor treatment or investigational products within 28 days or 5 half-lives before the start of IP, whichever comes earlier. The antitumor treatments include chemotherapy...
- Patients who had received CD137-targeted therapeutics within 28 days or 5 half-lives before the start of IP, whichever comes earlier.
- Patients who had major surgery within 28 days before the start of IP (excluding prior diagnostic biopsy).
- Patients who had continuance of toxicities due to prior antitumor agents that have not resolved to Grade ≤ 1 per NCI CTCAE version 5.0, except alopecia, and\< Grade 2 sensory neuropathy.
- Patients with a history of immune mediated AE of any grade that resulted in discontinuation of prior immunotherapy.
- Patients with previous malignant disease other than the target malignancy to be investigated in this study within the last 2 years with the exception of resected basal or squamous cell carcinoma of the skin, superficial...
- Patients with active leptomeningeal disease or uncontrolled, untreated brain metastasis. Patients with a history of treated and, at the time of Screening, stable central nervous system (CNS) metastases are eligible...
- Brain imaging at Screening shows no evidence of interim progression, patient is clinically stable for at least 2 weeks and without evidence of new brain metastases.
- Measurable disease outside the CNS.
- No ongoing requirement for corticosteroids as therapy for CNS disease; off steroids 2 weeks before the first dose of AP402; anticonvulsants at a stable dose are allowed.
- Patients who received any organ transplantation including allogeneic stem cell transplantation.
- Patients with significant acute or chronic infections including, among others:
- Infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before first dose of AP402.
- Known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Note: An HIV serology test (including antigen and/or antibodies) will be conducted at baseline for the patients with unknown HIV status and patients with positive HIV test will be excluded.
- Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV deoxyribonucleic acid (DNA) \> 500 IU/mL (or \> 2500 copies/mL) at Screening.
- NOTE: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA \ 2 weeks before the first dose of AP402.
- Patients with active hepatitis C.
- NOTE: Patients with a negative hepatitis C virus (HCV) antibody test at Screening or positive HCV antibody test followed by a negative HCV ribonucleic acid (RNA) test at Screening are eligible. The HCV RNA test will be...
- Patients with active or history of any autoimmune disease that may relapse (patients with diabetes Type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible) or...
- Patients with known severe hypersensitivity reactions to monoclonal antibodies.
- Patients with pregnancy or lactation period. Note: a negative pregnancy test is required for WOCBP.
- Patients with known alcohol or drug abuse.
- Patients with clinically significant (ie, active) cardiovascular disease: cerebral vascular accident/stroke (\ 480 msec.
- Patients with a left ventricular ejection fraction (LVEF) lower than 55% at Screening.
- Patients with any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- Patients with live (or live attenuated) vaccination within 28 days of the first dose of AP402 and during the study period.
- NOTE: COVID-19 vaccinations are permitted while a patient is on the study.
- Patients with all other significant diseases, in the opinion of the Investigator, might impair the patient's tolerance of the IP.
The study team makes the final eligibility decision.
Where it's taking place
- Macquarie, New South Wales, Australia
- Bedford Park, South Australia, Australia
- Perth, Western Australia, 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 Macquarie, New South Wales, Australia; Bedford Park, South Australia, Australia; Perth, Western Australia, 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.