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A Phase 1, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AB0024 in Adult Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

A Phase 1, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AB0024 in Adult Patients With Advanced Solid Tumors


This is a first-in-human, open-label, sequential dose escalation study to evaluate AB0024 in
patients with advanced solid tumors. The study will consist of two parts: Part A will be a
dose escalation, and Part B will be a dose expansion.The primary objective of this study is
to characterize the safety, tolerability, and PK of AB0024 after multiple IV administrations
in patients with advanced solid tumors. The secondary objectives are to measure the tumor
response by modified RECIST and to evaluate the formation of anti-AB0024 antibodies.

Patients will receive infusions of AB0024 every two weeks. Patients will be seen weekly for
safety assessments and collection of blood samples. Patients who do not show evidence of
disease progression by clinical assessment or by CT or MRI may continue receiving AB0024
every 2 weeks until disease progression (clinical or radiographic), study drug intolerance,
or withdrawal of consent.


Inclusion Criteria:



- Histologically or cytologically confirmed advanced malignant solid tumor that is
refractory to, intolerant of, or for which no standard of therapy is available

- Measurable or evaluable disease

- ECOG Performance Status of ≤2

- No known active central nervous system (CNS) tumors or CNS metastases

- Adequate organ function

Exclusion Criteria:

- Myocardial infarction within the last 6 months of study Day 1, symptomatic congestive
heart failure (New York Heart Association Classification > Class II), unstable
angina, or unstable cardiac arrhythmia requiring medication

- History of surgery within 28 days prior to enrollment or anticipated surgery during
the study period

- Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy,
retinoid therapy, hormonal therapy) within 28 days of study Day 1 (six weeks for
nitrosoureas, mitomycin C, antibodies, or molecular agents with t½ >10 days);
(concurrent use of hormone therapy for breast or prostate cancer is permitted)

- Treatment with immune modulators including, but not limited to, cyclosporine and
tacrolimus within two weeks prior to enrollment

- Concurrent or prior (within 30 days of study Day 1) anticoagulation therapy;
(low-dose warfarin [<2 mg/day] for prophylaxis against central venous catheter
thrombosis is allowed)

- Patient with tumor that is infiltrating or invading a major blood vessel

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To characterize the safety, tolerability, and pharmacokinetics (PK) of AB0024 after multiple intravenous (IV) administrations in patients with advanced solid tumors.

Outcome Time Frame:

Day 71

Safety Issue:

Yes

Principal Investigator

Patricia LoRusso, DO

Investigator Role:

Principal Investigator

Investigator Affiliation:

Karmanos Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

AB0024-101

NCT ID:

NCT01323933

Start Date:

June 2010

Completion Date:

March 2012

Related Keywords:

  • Neoplasms
  • Solid tumors
  • Oncology
  • Cancer
  • Neoplasms

Name

Location

Karmanos Cancer Institute Detroit, Michigan  48201
South Texas Accelerated Research Therapeutics San Antonio, Texas  78229