Study of KBA1412 in Participants With Advanced Solid Malignant Tumors
- Conditions
- Advanced Solid Tumor Malignancy
- Interventions
- Drug: KBA1412Drug: Pembrolizumab
- Registration Number
- NCT05501821
- Lead Sponsor
- Kling Biotherapeutics B.V.
- Brief 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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A, dose escalation monotherapy KBA1412 KBA1412 monotherapy, given intravenously, Q3W, multiple dose levels Part B, expansion monotherapy KBA1412 KBA1412 monotherapy, given intravenously, Q3W, at fixed dose as defined in dose-escalation phase (Part A) Part C, expansion combination therapy KBA1412 KBA1412 in combination with pembrolizumab, given intravenously, Q3W, KBA1412 at fixed dose as defined in dose-escalation phase (Part A), Pembrolizumab at fixed dose Part C, expansion combination therapy Pembrolizumab KBA1412 in combination with pembrolizumab, given intravenously, Q3W, KBA1412 at fixed dose as defined in dose-escalation phase (Part A), Pembrolizumab at fixed dose
- Primary Outcome Measures
Name Time Method Number of participants with an antitumor response to KBA1412 monotherapy (Part B) or to KBA1412 in combination with pembrolizumab (Part C) Approximately 24 weeks Response according to immune Response Evaluation Criteria in Solid Tumors (iRECIST)
Part A: Frequency and type of DLT s using the CTCAE v5.0 First 21 days of treatment 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
Part A & B & C: Frequency and severity of AEs as assessed by CTCAE v5.0 Through study completion, an average of 1 year Monitoring incidence and severity of Adverse Events during trial participation for each participant
- Secondary Outcome Measures
Name Time Method Part A: Number of participants with an antitumor response to KBA1412 monotherapy Approximately 24 weeks Response according to immune Response Evaluation Criteria in Solid Tumors (iRECIST)
Change in biomarkers for KBA1412 monotherapy (Part A & B) and KBA1412 in combination with pembrolizumab (Part C) pre- and post-dose in tumor tissue Approximately 24 weeks Change in pharmacodynamic properties of KBA1412 pre- and post-dose in immune infiltration, activation and cytotoxicity assessed by Immunohistochemistry
Incidence and prevalence of anti-KBA1412 antibodies for KBA1412 monotherapy (Part A & B) and KBA1412 in combination with pembrolizumab (Part C) Approximately 24 weeks Development of antibodies (anti-drug antibodies) to KBA1412 will be evaluated for all participants
Pharmacokinetic of KBA1412 monotherapy (Part A & B) and KBA1412 in combination with pembrolizumab (Part C), area under the concentration versus time curve (AUC) Approximately 24 weeks Area under the plasma concentration versus time curve (AUC) of KBA1412 will be assessed in all participants
Trial Locations
- Locations (5)
University Hospital Ghent
🇧🇪Ghent, Belgium
Dutch Cancer Institute AVL
🇳🇱Amsterdam, Netherlands
Erasmus Medical Center Rotterdam
🇳🇱Rotterdam, Netherlands
University Hospital Antwerp
🇧🇪Antwerp, Belgium
University Hospital Leiden (LUMC)
🇳🇱Leiden, Netherlands