Know Cancer

or
forgot password

Study of the Anti-EphA3 Monoclonal Antibody KB004 in Subjects With EphA3-Expressing Hematologic Malignancies


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Acute Myeloid Leukemia (AML), Acute Lymphocytic Leukemia (ALL), Chronic Myelogenous Leukemia (CML), Chronic Lymphocytic Leukemia (CLL), Myelodysplastic Syndrome (MDS), Multiple Myeloma (MM), Myeloproliferative Neoplasms (MPN)

Thank you

Trial Information

Study of the Anti-EphA3 Monoclonal Antibody KB004 in Subjects With EphA3-Expressing Hematologic Malignancies


Inclusion Criteria:



- 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),
Myeloproliferative Neoplasms (MPN)

- Eastern Cooperative Oncology Group (ECOG) ≤1

- Acceptable laboratory results

Exclusion Criteria:

- Active central nervous system (CNS) involvement due to leukemia

- Recent major surgery

- Ongoing surgical or wound healing complications

- Active clinically significant bleeding

- Uncontrolled hypertension

- Significant intercurrent illness

- Pregnant or breastfeeding women

- Unable or unwilling to provide written informed consent

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine a possible maximum tolerated dose (MTD)

Outcome Description:

Determination of a possible MTD as assessed by the number of subjects experiencing KB004-related adverse events that are considered dose limiting in nature

Outcome Time Frame:

Once weekly for the first three weeks of study treatment

Safety Issue:

Yes

Principal Investigator

Nestor A. Molfino, MD, MSc

Investigator Role:

Study Chair

Investigator Affiliation:

KaloBios Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

KB004-01

NCT ID:

NCT01211691

Start Date:

September 2010

Completion Date:

September 2014

Related Keywords:

  • Acute Myeloid Leukemia (AML)
  • Acute Lymphocytic Leukemia (ALL)
  • Chronic Myelogenous Leukemia (CML)
  • Chronic Lymphocytic Leukemia (CLL)
  • Myelodysplastic Syndrome (MDS)
  • Multiple Myeloma (MM)
  • Myeloproliferative Neoplasms (MPN)
  • Hematologic
  • Leukemia
  • Malignancies
  • Myeloproliferative Neoplasms
  • Neoplasms
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Hematologic Neoplasms

Name

Location

Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Austin, Texas  78705