Study of KBA1412 in Participants With Advanced Solid Malignant Tumors
- Conditions
- Advanced Solid Tumor Malignancy
- Registration Number
- NCT05501821
- Lead Sponsor
- Kling Biotherapeutics B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 16
<br><br> - Male or female patients aged =18 years.<br><br> - Histologically and/or cytologically confirmed locally advanced or metastatic solid<br> tumors refractory to standard therapy or for whom no standard therapy is available.<br><br> - For Parts B and C, patients for whom anti-PD-1 or anti-programmed cell death ligand<br> 1 (anti-PD-L1) are the SOC should have progressed on these therapies before being<br> eligible for enrollment in Parts B and C. Patients cannot have received more than<br> one anti-PD-1 or anti-PD-L1 based regimen.<br><br> - Disease accessible for core needle biopsy both pre- and post-treatment with KBA1412.<br> Biopsies will be mandatory for patients with melanoma and required for other tumor<br> types depending on feasibility of obtaining tissue.<br><br> - Measurable disease defined as: At least 1 lesion of =10 mm in the longest diameter<br> for a non lymph node or =15 mm in the short-axis diameter for a lymph node that is<br> serially measurable according to iRECIST using CT/MRI and will not be used for<br> on-study paired biopsies.<br><br> - ECOG Performance Status of 0-1.<br><br> - Adequate hematologic, renal and hepatic function<br><br>Exclusion criteria:<br><br> - History of severe hypersensitivity reactions to other monoclonal antibodies.<br><br> - Prior treatment with:<br><br> - Any chemotherapy, anticancer small molecule therapy or investigational drug or<br> device within 14 days or 5 half-lives (whichever is longer) prior to study<br> treatment administration<br><br> - Biological agents (including monoclonal antibodies) within 28 days prior to<br> study treatment administration<br><br> - Radiation, within 14 days prior to study treatment administration<br><br> - Treatment with nitrosoureas or mitomycin C require a 42-day washout prior to<br> study treatment administration<br><br> - Anti-CD40 antibody or with FMS-like tyrosine kinase 3 ligand (FLT3L)<br><br> - KBA1412.<br><br> - Major surgery or significant traumatic injury within 4 weeks prior to study<br> treatment administration.<br><br> - Excluding the primary tumor leading to enrollment in this study, any other active<br> malignancy (except for definitively treated melanoma in-situ, basal or squamous cell<br> carcinoma of the skin, or carcinoma in-situ of the bladder or cervix) within 24<br> months prior to study treatment administration.<br><br> - Untreated primary central nervous system (CNS) malignancy.<br><br> - Use of immunosuppressive medications within 4 weeks or systemic corticosteroids at<br> doses exceeding 10 mg/ day (prednisone equivalent) within 2 weeks prior to study<br> treatment administration.<br><br> - Active autoimmune disease that has required systemic treatment within 2 years prior<br> to study treatment administration.<br><br> - Clinically significant cardiovascular disease, e.g., cerebral vascular<br> accident/stroke or myocardial infarction, within 6 months prior to study treatment<br> administration, unstable angina, congestive heart failure (New York Heart<br> Association [NYHA] Class =III), or unstable cardiac arrhythmia requiring medication.<br><br> - History of a major bleeding event (requiring a blood transfusion of >2 units) not<br> related to a tumor within 12 months prior to study treatment administration.<br><br> - Ongoing Common Terminology Criteria for Adverse Events (CTCAE) Grade =2 toxicity<br> related to a previously administered anticancer agent with the following exceptions:<br><br> - CTCAE Grade 2 neuropathy or alopecia<br><br> - CTCAE Grade 2 immune-related endocrinopathy attributed to a checkpoint<br> inhibitor and controlled with hormone replacement alone.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Part A & B & C: Frequency and severity of AEs as assessed by CTCAE v5.0;Part A: Frequency and type of DLT s using the CTCAE v5.0;Number of participants with an antitumor response to KBA1412 monotherapy (Part B) or to KBA1412 in combination with pembrolizumab (Part C)
- Secondary Outcome Measures
Name Time Method Part A: Number of participants with an antitumor response to KBA1412 monotherapy;Pharmacokinetic of KBA1412 monotherapy (Part A & B) and KBA1412 in combination with pembrolizumab (Part C), area under the concentration versus time curve (AUC);Incidence and prevalence of anti-KBA1412 antibodies for KBA1412 monotherapy (Part A & B) and KBA1412 in combination with pembrolizumab (Part C);Change in biomarkers for KBA1412 monotherapy (Part A & B) and KBA1412 in combination with pembrolizumab (Part C) pre- and post-dose in tumor tissue