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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Part A, B, C
Part C only
University Hospital Antwerp
Antwerp, Belgium
University Hospital Ghent
Ghent, Belgium
Dutch Cancer Institute AVL
Amsterdam, Netherlands
University Hospital Leiden (LUMC)
Leiden, Netherlands
Part A & B & C: Frequency and severity of AEs as assessed by CTCAE v5.0
Monitoring incidence and severity of Adverse Events during trial participation for each participant
Time frame: Through study completion, an average of 1 year
Part A: Frequency and type of DLT s using the CTCAE v5.0
A DLT is defined as an adverse event that is unrelated to disease progression, intercurrent illness, or concomitant medications and is occurring during the first 21 days of treatment. These events will be classified according to the CTCAE v5.0
Time frame: First 21 days of treatment
Number of participants with an antitumor response to KBA1412 monotherapy (Part B) or to KBA1412 in combination with pembrolizumab (Part C)
Response according to immune Response Evaluation Criteria in Solid Tumors (iRECIST)
Time frame: Approximately 24 weeks
Part A: Number of participants with an antitumor response to KBA1412 monotherapy
Response according to immune Response Evaluation Criteria in Solid Tumors (iRECIST)
Time frame: Approximately 24 weeks
Pharmacokinetic of KBA1412 monotherapy (Part A & B) and KBA1412 in combination with pembrolizumab (Part C), area under the concentration versus time curve (AUC)
Area under the plasma concentration versus time curve (AUC) of KBA1412 will be assessed in all participants
Time frame: Approximately 24 weeks
Incidence and prevalence of anti-KBA1412 antibodies for KBA1412 monotherapy (Part A & B) and KBA1412 in combination with pembrolizumab (Part C)
Development of antibodies (anti-drug antibodies) to KBA1412 will be evaluated for all participants
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Erasmus Medical Center Rotterdam
Rotterdam, Netherlands
Time frame: Approximately 24 weeks
Change in biomarkers for KBA1412 monotherapy (Part A & B) and KBA1412 in combination with pembrolizumab (Part C) pre- and post-dose in tumor tissue
Change in pharmacodynamic properties of KBA1412 pre- and post-dose in immune infiltration, activation and cytotoxicity assessed by Immunohistochemistry
Time frame: Approximately 24 weeks