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Clinical Trials/NL-OMON53468
NL-OMON53468RecruitingNot Applicable

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 - Study of KBA1412 in patients with advanced solid malignant tumors

Kling Biotherapeutics B.V.0 sites22 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
22
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • •Male or female patients aged >=18 years with 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, tumor types are initially restricted to melanoma, ovarian
  • •cancer, gastric cancer, and colorectal. Any additional tumor types may be added
  • •as defined by the SRC.
  • •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
  • •Biopsies will be mandatory 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 Response Evaluation Criteria in
  • •Solid Tumors for immunotherapy (iRECIST) using computerized tomography/magnetic
  • •resonance imaging (CT/MRI) and will not be used for on-study paired biopsies.
  • •Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1.
  • •Adequate hematologic function as defined by:
  • •- Absolute neutrophil count >= 1500/µL.
  • •- Platelet count >=175.000/µL.
  • •- Hemoglobin >= 9.0 g/dL (transfusion and growth factor independent).
  • •- Prothrombin time/international normalized ratio (PT/INR) and partial
  • •thromboplastin time (PTT) <=1.5 × upper limit of normal (ULN).

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.
  • •Primary central nervous system (CNS) malignancy.
  • •Patients with stable CNS metastases post radiotherapy and no longer receiving
  • •corticosteroids prior to study treatment administration, may be considered for
  • •this study.
  • •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.
  • •History of clinically significant coagulation or platelet disorder or a
  • •history of being refractory to platelet transfusions within 12 months prior to
  • •study treatment administration.
  • •Receiving or requiring anticoagulation therapy or any drug or herbal
  • •supplements that affect platelet function, with exception of low-dose
  • •anticoagulation medications that are used to maintain the patency of a central
  • •IV catheter. Enrolment of a patient is allowed 2 weeks after stop of use of
  • •anticoagulation therapy or medications.

Investigators

Sponsor
Kling Biotherapeutics B.V.

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