A Phase I, First-in-human, Multicenter, Open-label, Dose Escalation Followed by an Expansion Phase Clinical Study of KBA1412 Given as Monotherapy or in Combination With Pembrolizumab in Adults With Advanced Solid Malignant Tumors
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 16
- Locations
- 5
- Primary Endpoint
- Number of participants with an antitumor response to KBA1412 monotherapy (Part B) or to KBA1412 in combination with pembrolizumab (Part C)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Part A, dose escalation monotherapy
KBA1412 monotherapy, given intravenously, Q3W, multiple dose levels
Intervention: KBA1412 (Drug)
Part B, expansion monotherapy
KBA1412 monotherapy, given intravenously, Q3W, at fixed dose as defined in dose-escalation phase (Part A)
Intervention: KBA1412 (Drug)
Part C, expansion combination therapy
KBA1412 in combination with pembrolizumab, given intravenously, Q3W, KBA1412 at fixed dose as defined in dose-escalation phase (Part A), Pembrolizumab at fixed dose
Intervention: KBA1412 (Drug)
Part C, expansion combination therapy
KBA1412 in combination with pembrolizumab, given intravenously, Q3W, KBA1412 at fixed dose as defined in dose-escalation phase (Part A), Pembrolizumab at fixed dose
Intervention: Pembrolizumab (Drug)
Outcomes
Primary Outcomes
Number of participants with an antitumor response to KBA1412 monotherapy (Part B) or to KBA1412 in combination with pembrolizumab (Part C)
Time Frame: 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
Time Frame: 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
Time Frame: Through study completion, an average of 1 year
Monitoring incidence and severity of Adverse Events during trial participation for each participant
Secondary Outcomes
- Part A: Number of participants with an antitumor response to KBA1412 monotherapy(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(Approximately 24 weeks)
- Incidence and prevalence of anti-KBA1412 antibodies for KBA1412 monotherapy (Part A & B) and KBA1412 in combination with pembrolizumab (Part C)(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)(Approximately 24 weeks)