Overview
Study of KBA1412 in Participants With Advanced Solid Malignant Tumors
Status:
Recruiting
Recruiting
Trial end date:
2025-01-01
2025-01-01
Target enrollment:
0
0
Participant gender:
All
All
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 tumorsPhase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Kling Biotherapeutics B.V.Treatments:
Pembrolizumab
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.