A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With Advanced Solid Tumors
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ClinicalTrials.gov Identifier: NCT02561234 |
Recruitment Status :
Completed
First Posted : September 28, 2015
Last Update Posted : November 5, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Cancers | Drug: Co-ArgI-PEG | Phase 1 Phase 2 |
In this phase I/2 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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 98 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multiple Dose, Dose Escalation Trial of AEB1102 (Co-ArgI-PEG) in Patients With Advanced Solid Tumors |
Study Start Date : | October 2015 |
Actual Primary Completion Date : | May 2019 |
Actual Study Completion Date : | May 2019 |
Arm | Intervention/treatment |
---|---|
Experimental: AEB1102 Dose Escalation Cohort 1
3 patients dosed at 0.01 mg/kg until MTD determined
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Drug: Co-ArgI-PEG
Administered IV
Other Name: AEB1102 |
Experimental: AEB1102 Dose Escalation Cohort 2
4 patients dosed at 0.02 mg/kg until MTD determined
|
Drug: Co-ArgI-PEG
Administered IV
Other Name: AEB1102 |
Experimental: AEB1102 Dose Escalation Cohort 3
4 patients dosed at 0.04 mg/kg until MTD determined
|
Drug: Co-ArgI-PEG
Administered IV
Other Name: AEB1102 |
Experimental: AEB1102 Dose Escalation Cohort 4
4 patients dosed at 0.08 mg/kg until MTD determined
|
Drug: Co-ArgI-PEG
Administered IV
Other Name: AEB1102 |
Experimental: AEB1102 Dose Escalation Cohort 5
3 patients dosed at 0.12 mg/kg until MTD determined
|
Drug: Co-ArgI-PEG
Administered IV
Other Name: AEB1102 |
Experimental: AEB1102 Dose Escalation Cohort 6
4 patients dosed at 0.18 mg/kg until MTD determined
|
Drug: Co-ArgI-PEG
Administered IV
Other Name: AEB1102 |
Experimental: AEB1102 Dose Escalation Cohort 7
5 patients dosed at 0.27 mg/kg until MTD determined
|
Drug: Co-ArgI-PEG
Administered IV
Other Name: AEB1102 |
Experimental: AEB1102 Dose Escalation Cohort 8
7 patients dosed at 0.40 mg/kg until MTD determined
|
Drug: Co-ArgI-PEG
Administered IV
Other Name: AEB1102 |
Experimental: AEB1102 Dose Escalation Cohort 9
7 patients dosed at 0.33 mg/kg until MTD determined MTD determined at 0.33 mg/kg
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Drug: Co-ArgI-PEG
Administered IV
Other Name: AEB1102 |
Experimental: AEB1102 Expansion
Uveal: 11 patients dosed at 0.33 mg/kg Cutaneous Melanoma: 11 dosed at 0.33 mg/kg SCLC: 13 patients dosed at 0.33 mg/kg
|
Drug: Co-ArgI-PEG
Administered IV
Other Name: AEB1102 |
- maximum tolerated dose [ Time Frame: 4 weeks ]the dose level at which no more than 1/6 patients experiences dose-limiting toxicity
- safety profile (changes in physical exam, laboratory measures, reported adverse events) [ Time Frame: 4 weeks + ]changes in physical exam, laboratory measures, reported adverse events

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02561234
United States, Arizona | |
Pinnacle Research | |
Phoenix, Arizona, United States, 85258 | |
United States, California | |
UCLA | |
Los Angeles, California, United States, 90024 | |
United States, Colorado | |
University of Colorado | |
Aurora, Colorado, United States, 80045 | |
United States, Florida | |
Research Center: Mid Florida Hematology/Oncology Centers | |
Orange City, Florida, United States, 32763 | |
United States, Massachusetts | |
Dana Farber | |
Boston, Massachusetts, United States, 02114 | |
Massachusetts General | |
Boston, Massachusetts, United States, 02114 | |
United States, Missouri | |
Washington University | |
Saint Louis, Missouri, United States, 93110 | |
United States, New York | |
Columbia University | |
New York, New York, United States, 10032 | |
United States, Oregon | |
Providence Cancer Center | |
Portland, Oregon, United States, 97213 | |
United States, Pennsylvania | |
University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15232 | |
United States, Texas | |
UTSW | |
Dallas, Texas, United States, 75390-8852 |
Study Director: | Jim Joffrion | Aeglea Biotherapeutics, Inc. |
Responsible Party: | Aeglea Biotherapeutics |
ClinicalTrials.gov Identifier: | NCT02561234 |
Other Study ID Numbers: |
CAEB1102-100B |
First Posted: | September 28, 2015 Key Record Dates |
Last Update Posted: | November 5, 2021 |
Last Verified: | November 2021 |