Study of KBA1412 in Participants With Advanced Solid Malignant Tumors

NCT05501821 | Completed Phase 1

• 1 other identifier: KBA1412-101
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 5

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

Conditions

Advanced Solid Tumor Malignancy

Keywords

solid tumor adult; refractory cancer

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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)

  Approximately 24 weeks

Secondary Outcomes (4)

• Part A: Number of participants with an antitumor response to KBA1412 monotherapy

  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

• Incidence and prevalence of anti-KBA1412 antibodies for KBA1412 monotherapy (Part A & B) and KBA1412 in combination with pembrolizumab (Part C)

  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

Study Arms (3)

Part A, dose escalation monotherapy

EXPERIMENTAL

KBA1412 monotherapy, given intravenously, Q3W, multiple dose levels

Drug: KBA1412

Part B, expansion monotherapy

EXPERIMENTAL

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

Drug: KBA1412

Part C, expansion combination therapy

EXPERIMENTAL

KBA1412 in combination with pembrolizumab, given intravenously, Q3W, KBA1412 at fixed dose as defined in dose-escalation phase (Part A), Pembrolizumab at fixed dose

Drug: KBA1412; Drug: Pembrolizumab

Interventions

KBA1412 DRUG

Part A, B, C

Part A, dose escalation monotherapy; Part B, expansion monotherapy; Part C, expansion combination therapy

Pembrolizumab DRUG

Part C only

Also known as: Keytruda

Part C, expansion combination therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kling Biotherapeutics B.V.: lead

Study Sites (5)

University Hospital Antwerp

Antwerp, 2650, Belgium

Location

University Hospital Ghent

Ghent, 9000, Belgium

Location

Dutch Cancer Institute AVL

Amsterdam, 1066 CX, Netherlands

Location

University Hospital Leiden (LUMC)

Leiden, 2333 ZA, Netherlands

Location

Erasmus Medical Center Rotterdam

Rotterdam, 3015 GD, Netherlands

Location

MeSH Terms

Conditions

Neoplasms

Interventions

pembrolizumab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A will consist of multiple cohorts, each at an escalated dose level of KBA1412. Part B will consist of disease specific cohorts, each cohort treated with KBA1412 at a fixed dose level. Part C will consist of disease specific cohorts, each cohort treated with KBA1412 at a fixed dose in combination with pembrolizumab at a fixed dose.

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 15, 2022
• Study Start: August 8, 2022
• Primary Completion: July 24, 2024
• Study Completion: July 24, 2024
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3); BE (2)