Trial Search Results

Study of KB004 in Subjects With Hematologic Malignancies (Myelodysplastic Syndrome, MDS, Myelofibrosis, MF)

The main purpose of this clinical research study is to find the highest tolerable dose of the study drug KB004, which is being tested as a possible therapy for people with types of blood cancers (leukemia). This study will also explore whether KB004 has the potential to kill tumors in humans, is safe for people to take, and see how KB004 is absorbed by the body.

KB004 is a type of drug commonly called a monoclonal antibody. KB004 is intended to kill blood cancer cells by binding to a part of the cancer cell called EphA3.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Humanigen, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: KB004, Monoclonal Antibody

Phase:

Phase 1/Phase 2

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting