Study of KBA1412 in Participants With Advanced Solid Malignant Tumors

NCT ID: NCT05501821

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-08
• Study Completion Date: 2024-07-24

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.

Conditions

Advanced Solid Tumor Malignancy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A, dose escalation monotherapy

KBA1412 monotherapy, given intravenously, Q3W, multiple dose levels

Group Type: EXPERIMENTAL

KBA1412

Intervention Type: DRUG

Part A, B, C

Part B, expansion monotherapy

KBA1412 monotherapy, given intravenously, Q3W, at fixed dose as defined in dose-escalation phase (Part A)

Group Type: EXPERIMENTAL

KBA1412

Intervention Type: DRUG

Part A, B, C

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

Group Type: EXPERIMENTAL

KBA1412

Intervention Type: DRUG

Part A, B, C

Pembrolizumab

Intervention Type: DRUG

Part C only

Interventions

KBA1412

Part A, B, C

Intervention Type: DRUG

Pembrolizumab

Part C only

Intervention Type: DRUG

Other Intervention Names

Keytruda

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kling Biotherapeutics B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Antwerp

Antwerp, , Belgium

University Hospital Ghent

Ghent, , Belgium

Dutch Cancer Institute AVL

Amsterdam, , Netherlands

University Hospital Leiden (LUMC)

Leiden, , Netherlands

Erasmus Medical Center Rotterdam

Rotterdam, , Netherlands

Countries

Belgium; Netherlands

Other Identifiers

KBA1412-101

Identifier Type: -

Identifier Source: org_study_id