©2022 Stanford Medicine
Study of KB004 in Subjects With Hematologic Malignancies (Myelodysplastic Syndrome, MDS, Myelofibrosis, MF)
Not Recruiting
Trial ID: NCT01211691
Purpose
This is a global, multicenter, open-label, repeat-dose, Phase 1/2 study consisting of a Dose
Escalation Phase (Phase 1) and a Cohort Expansion Phase (Phase 2). In both phases, KB004 will
be administered by IV infusion once weekly as part of a 21-day dosing cycle.
Official Title
Study of the Anti-EphA3 Monoclonal Antibody KB004 in Subjects With EphA3-Expressing Hematologic Malignancies
Stanford Investigator(s)
Peter Greenberg
Professor of Medicine (Hematology), Emeritus
Eligibility
Key Inclusion Criteria (Phase 1):
- Confirmed hematologic malignancy, including Acute Myeloid Leukemia (AML), Chronic
Lymphocytic Leukemia (CLL), Chronic Myelogenous Leukemia (CML), Acute Lymphocytic Leukemia
(ALL), Myelodysplastic Syndrome (MDS), Multiple Myeloma (MM), Myelofibrosis (MF),
Myeloproliferative Neoplasms (MPN) or MDS/MPN overlap diseases. (Once Phase 2 has started
subjects with AML will be eligible for inclusion in the Phase 1 portion of the study only
if their malignancy has been shown to have c-Cbl mutation, trisomy 3, trisomy 11, inv(16),
or elevated FLT3. [Other AML and subjects with MDS will no longer be eligible for inclusion
in the Phase 1 portion of the study]).
Key Inclusion Criteria (Phase 2):
- Part A: AML or MDS patients with an acceptable level of EphA3 expression
- Part B: MF patients with an acceptable level of EphA3 expression
Key Inclusion Criteria (Both Phases):
- Confirmed hematologic malignancy refractory to or progressed following standard
treatments, or subjects not considered medically suitable to receive standard of care
treatment or who refuse standard of care treatment
- Acceptable level of EphA3 expression
- Eastern Cooperative Oncology Group (ECOG) ≤1
- Acceptable laboratory results
Key Exclusion Criteria (Both Phases):
- For subjects with AML, more than 2 prior therapies for AML (induction and
consolidation with or without a hypomethylating agent given in a maintenance setting
are considered 1 therapy)
- History of or current central nervous system (CNS) involvement that may increase risk
of bleeding
- Recent major surgery
- Ongoing surgical or wound healing complications
- Active clinically significant bleeding
- Uncontrolled hypertension
- Significant intercurrent illness
- Known history of prolonged bleeding times or platelet dysfunction
- Active infection requiring IV antibiotics, IV antifungals, or IV antivirals within 2
weeks prior to Cycle 1, Day 1
Intervention(s):
drug: KB004, Monoclonal Antibody
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061