Brief Summary
AXA-042 functions through a multi-cellular mechanism to re-engage the innate immune response. This first-in-human study is planned to evaluate the safety, tolerability, pharmacokinetics (PK), preliminary efficacy, and pharmacodynamics (PD) of AXA-042 as monotherapy in subjects with advancedat a late stage, far along solid tumors.
Intervention/Treatment
- Drug: AXA-042.
Inclusion Criteria
- Diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of a histologically or cytologically confirmed locally advanced or metastatic cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs (all solid tumors). Subjects must be considered refractory or intolerant to the standard of care therapies or have refused standard therapy.
- Age greater than or equal to 18 years old at the time of Screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening (signing the Informed Consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. Form [ICF]).
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group performance status 0 to 1.
- The estimated life expectancy of at least 3 months as per the Investigator’s judgment.
- At least one measurable disease tumoura tissue mass that forms from groups of unhealthy cells lesion by Response Evaluation Criteria in Solid
Tumours Version 1.1 (RECIST v1.1) criteria.10 For suitable subjects, such as subjects that
may not have measurable lesions, positron emission tomography (PET) may be implemented in addition to, or in place of, RECIST 1.1, to monitorto check on, keep track of disease response (PERCIST; PET response criteria in solid tumours version 1.0) on discussion and approval by the sponsor’s medical monitor. - Subjects who have undergone treatment with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodya protein made by the immune system to fight against harmful substances (antigens), such as bacteria or viruses must have a gap of at least 4 weeks from the last dosethe amount of medication taken of antibody and evidence of disease progression per the Investigator’s assessment before enrollment.
- Subjects who have previously received an immune CPI prior to enrollment must have any immune-related toxicities resolved to less than or equal to Gradea description of how abnormal cancer cells and tissue look under a microscope when compared to healthy cells 1 or baseline (prior to the CPI) with the exception of toxicities not considered a safety riskthe possibility that something bad will happen (eg, hypothyroidisma condition that occurs when the thyroid doesn't produce enough thyroid hormones, also known as underactive thyroid, alopeciathe partial or complete absence of hair from areas of the body where it normally grows; baldness, neuropathy, or asymptomatic laboratory abnormalities).
- Adequate organ function based on laboratory assessments at Screening, as defined by:
- Hemoglobin greater than or equal to 90 g/L (subjects may be transfused >2 weeks before Screening, but should not be transfusion-dependent).
- Plateletssmall disc-shaped blood cells that clump together to form clots to stop bleeding greater than or equal to 100 × 109/L.
- Absolute neutrophil count greater than or equal to 1.5 × 109/L.
- Serum creatinine less than or equal to 1.5 × upper limit of normal (ULN); or a calculated creatinine clearance (Cockcroft-Gault method) greater than or equal to 50 mL/minute if serum creatinine >1.5 × ULN. Lower calculated creatinine clearance values may be allowed at the Investigator’s discretion and in consultation with the Medical Monitor and Sponsor.
- Total bilirubin less than or equal to ULN; or conjugated bilirubin less than or equal to ULN and total bilirubin less than or equal to 1.5 × ULN (<3.0 × ULN for subjects with liver metastases or Gilbert’s syndrome).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 × ULN (AST and ALT less than or equal to 5 × ULN if liver metastases present).
- International normalized ratio and activated partial thromboplastin time less than or equal to 1.5 × ULN.
- For Part A, available archived tumor tissuea group of cells that work together to perform a function sample (block of formalin-fixed paraffin-embedded [FFPE] tissues) to allow for exploratory biomarker studies. In the setting where archival material is unavailable or unsuitable for use (eg, recently diagnosed subjects or diagnosed with fine-needle aspiration), the subject will have an option to consent for and undergo fresh tumor biopsyremoval of a section of tissue to analyse for cancer cells (at acceptable risk as judged by the Investigator). The requirement for fresh biopsy collected from a given subject could be waived after the discussion with the Medical Monitor if the tumor tissues are not safely accessible as determined by the Investigator or the tumor biopsies have to be obtained from sites that require significant risk procedures.
- Female subjects must not be pregnant, or must be of non-childbearing potential; or if of childbearing potential, must agree to use highly effective birth control methods during the study treatment period and for at least 90 days after the last dose of the study treatment.
- Non-sterilized male subjects must agree to use contraception of this protocol during the treatment period and for at least 90 days after the last dose of the study treatment for Part A.
- For women of childbearing potential (WOCBP) only: A negative serum pregnancy test during Screening and a negative serum or urine pregnancy test within 24 hours of the first dose of study treatment.
- Voluntarily agrees to participate by giving written informed consent and is willing and able to comply with this protocol and scheduled visits.