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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)

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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