A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With Advanced Solid Tumors



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:October 2015
End Date:June 2019
Contact:Aeglea Clinical Department
Email:oncology@aegleabio.com
Phone:1.855.509.9921

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A Phase I Multiple Dose, Dose Escalation Trial of AEB1102 (Co-ArgI-PEG) in Patients With Advanced Solid Tumors

This is the first-in-human study of the safety of increasing dose levels of AEB1102 in
patients with advanced cancers. The study will also evaluate the amounts of AEB1102 in blood,
the effects of AEB1102 on blood amino acid levels and tumor growth.

In this phase I multiple dose, dose escalation study utilizing a classic 3+3 design.
Sequential cohorts of patients will receive AEB1102 IV weekly at one of a series of
increasing dose levels. Dose escalation will be dependent on the frequency of specific
dose-limiting toxicities in the prior cohort of patients. The study will determine the
maximum tolerated dose (MTD) of AEB1102, evaluate the safety profile of the compound, assess
the pharmacokinetic profile of AEB1102, determine the effect of AEB1102 on blood arginine
levels and evaluate the anti-tumor activity of AEB1102.

Following the determination of the MTD, additional cohorts of patients with uveal, cutaneous
melanoma and small cell lung cancer will be enrolled and treated with AEB1102 at the MTD.

Inclusion Criteria:

For patients participating in any part of the trial:

- has an advanced solid tumor previously treated with, or inability to tolerate,
standard therapy for the disease, or for which a standard therapy does not exist, and
as such is considered a candidate for Phase 1 treatment

- has adequate organ function: Hgb ≥9 g/dL; absolute neutrophil count (ANC) ≥ 1.5x109/L;
plt ≥ 100,000/μL; AST and ALT < 2.5x ULN (< 5x ULN in patients with liver metastases);
total bilirubin < 2.0 mg/dL; serum creatinine ≤ 1.5x ULN

- ECOG performance score 0-2

For patients participating in any expansion group:

- has measurable disease based on RECIST 1.1 as determined by the treating investigator.
Tumor lesions in a previously irradiated area are considered measurable if progression
has been demonstrated in such lesions

- willing to consent for biopsy is strongly recommended but not mandatory

- recovery of toxicities related to any prior treatments to at least Grade 1 by CTCAE v
4.03. Exceptions are patients with adverse event(s) that are clinically nonsignificant
and/or stable on supportive therapy.

For patients participating in specific expansion groups:

Cutaneous Melanoma:

- unresectable, locally advanced or metastatic (AJCC stage IIIB, IIIC, or IV) cutaneous
malignant melanoma

- relapsed or progressive disease after or unable to tolerate at least one prior
systemic anticancer regimen for metastatic disease involving immunotherapy (anti-PD-1,
anti-PD-L1, or anti-CTLA-4)

- in tumors with a relevant BRAF mutation, relapsed, refactory, or unable to tolerate at
least one prior systemic anticancer regimen for metastic disease involving a BRAF
inhibitor

Uveal Melanoma:

- uveal melanoma at metastic stage

Small Cell Lung Cancer:

- extensive disease previously treated with, or inability to tolerate, platinum-based
chemotherapy

Exclusion Criteria:

- has primary CNS malignancy

- history of untreated brain mets or leptomeningeal disease or spinal cord compression

- effects of prior anticancer therapy recovered to grade < 2

- known HIV

- active infection

- major surgery within 2 weeks

- history of another malignancy within 2 years prior
We found this trial at
14
sites
Dallas, Texas 75246
Principal Investigator: James Strauss, MD
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Principal Investigator: Richard Carvajal, MD
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Principal Investigator: Timothy Burns, MD
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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Aurora, Colorado 80045
Principal Investigator: Karl Lewis, MD
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Boston, Massachusetts
Principal Investigator: Elizabeth Buchbinder, MD
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Boston, Massachusetts 02114
Principal Investigator: Ryan Sullivan, MD
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Dallas, Texas 75231
Principal Investigator: David Gerber, MD
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Los Angeles, California 90095
(310) 825-4321
Principal Investigator: Bart Chmielowski, MD
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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Orange City, Florida 32763
Principal Investigator: Santos Nair, MD
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9055 East Del Camino Drive
Phoenix, Arizona 85258
Principal Investigator: Michael Gordon, MD
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Portland, Oregon 97213
Principal Investigator: Brendan Curti, MD
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Portland, OR
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Saint Louis, Missouri 63110
Principal Investigator: Siddartha Devarakonda, MD
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Saint Louis, MO
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San Juan, 00927
Principal Investigator: Mirelis Acosta-Rivera, MD
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Whittier, California 90603
Principal Investigator: Merrill Shum, MD
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