Clinical trial · Interventional
Study of KB004 in Subjects With Hematologic Malignancies (Myelodysplastic Syndrome, MDS, Myelofibrosis, MF)
Study of the Anti-EphA3 Monoclonal Antibody KB004 in Subjects With EphA3-Expressing Hematologic Malignancies
NCT01211691CI-TRIAL-00019807suspendedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): KaloBios to Wind Down Operations
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myelodysplastic Syndrome (MDS) | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| Myelofibrosis (MF) | Primary Myelofibrosis | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KB004, Monoclonal Antibody | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase 1 dose levels: KB004
- description
- IV infusion 1x Weekly for a 21 day dosing cycle Subjects with heme malignancies will be assigned to one of 11 planned KB004 (dose levels (20mg, 40mg, 70mg, 100mg, 140mg, 190mg, 250mg, 330mg)
- interventionNames
- Drug: KB004, Monoclonal Antibody
- type
- EXPERIMENTAL
- label
- Phase 2 dose levels: KB004
- description
- IV infusion 1x Weekly for a 21 day dosing cycle Subjects will be assigned to the recommended Phase 2 dose of 250 mg
- interventionNames
- Drug: KB004, Monoclonal Antibody
Primary outcomes (2)
- measure
- Phase 1: Determine a possible maximum tolerated dose (MTD)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSwords RT, Greenberg PL, Wei AH, Durrant S, Advani AS, Hertzberg MS, Jonas BA, Lewis ID, Rivera G, Gratzinger D, Fan AC, Felsher DW, Cortes JE, Watts JM, Yarranton GT, Walling JM, Lancet JE. KB004, a first in class monoclonal antibody targeting the receptor tyrosine kinase EphA3, in patients with advanced hematologic malignancies: Results from a phase 1 study. Leuk Res. 2016 Nov;50:123-131. doi: 10.1016/j.leukres.2016.09.012. Epub 2016 Sep 28. PMID 27736729