study of kba1412 in participants with advanced solid malignant tumors

Conditions: Advanced Solid Tumor Malignancy

Summary: the purpose of this trial is to assess the safety and efficacy of kba1412, a patient derived, fully human, monoclonal antibody targeting cd9, in patients with advanced solid malignant tumors

patient interested in participation in a clinical study will be informed about the study and potential risks, all patients giving written informed consent will undergo a 3-week screening period to determine their eligibility for entry in the study. patients will receive kba1412 or kba1412 in combination with pembrolizumab.

Eligibility criteria:
inclusion criteria: * male or female patients aged ≥18 years. * histologically and/or cytologically confirmed locally advanced or metastatic solid tumors refractory to standard therapy or for whom no standard therapy is available. * for parts b and c, patients for whom anti-pd-1 or anti-programmed cell death ligand 1 (anti-pd-l1) are the soc should have progressed on these therapies before being eligible for enrollment in parts b and c. patients cannot have received more than one anti-pd-1 or anti-pd-l1 based regimen. * disease accessible for core needle biopsy both pre- and post-treatment with kba1412. biopsies will be mandatory for patients with melanoma and required for other tumor types depending on feasibility of obtaining tissue. * measurable disease defined as: at least 1 lesion of ≥10 mm in the longest diameter for a non lymph node or ≥15 mm in the short-axis diameter for a lymph node that is serially measurable according to irecist using ct/mri and will not be used for on-study paired biopsies. * ecog performance status of 0-1. * adequate hematologic, renal and hepatic function exclusion criteria: * history of severe hypersensitivity reactions to other monoclonal antibodies. * prior treatment with: * any chemotherapy, anticancer small molecule therapy or investigational drug or device within 14 days or 5 half-lives (whichever is longer) prior to study treatment administration * biological agents (including monoclonal antibodies) within 28 days prior to study treatment administration * radiation, within 14 days prior to study treatment administration * treatment with nitrosoureas or mitomycin c require a 42-day washout prior to study treatment administration * anti-cd40 antibody or with fms-like tyrosine kinase 3 ligand (flt3l) * kba1412. * major surgery or significant traumatic injury within 4 weeks prior to study treatment administration. * excluding the primary tumor leading to enrollment in this study, any other active malignancy (except for definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the bladder or cervix) within 24 months prior to study treatment administration. * untreated primary central nervous system (cns) malignancy. * use of immunosuppressive medications within 4 weeks or systemic corticosteroids at doses exceeding 10 mg/ day (prednisone equivalent) within 2 weeks prior to study treatment administration. * active autoimmune disease that has required systemic treatment within 2 years prior to study treatment administration. * clinically significant cardiovascular disease, e.g., cerebral vascular accident/stroke or myocardial infarction, within 6 months prior to study treatment administration, unstable angina, congestive heart failure (new york heart association \[nyha\] class ≥iii), or unstable cardiac arrhythmia requiring medication. * history of a major bleeding event (requiring a blood transfusion of \>2 units) not related to a tumor within 12 months prior to study treatment administration. * ongoing common terminology criteria for adverse events (ctcae) grade ≥2 toxicity related to a previously administered anticancer agent with the following exceptions: * ctcae grade 2 neuropathy or alopecia * ctcae grade 2 immune-related endocrinopathy attributed to a checkpoint inhibitor and controlled with hormone replacement alone.

Keywords: solid tumor adult refractory cancer