A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With Advanced Solid Tumors
1 other identifier
interventional
98
1 country
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2015
Typical duration for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2015
CompletedFirst Posted
Study publicly available on registry
September 28, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedNovember 5, 2021
November 1, 2021
3.6 years
August 25, 2015
November 3, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
maximum tolerated dose
the dose level at which no more than 1/6 patients experiences dose-limiting toxicity
4 weeks
Secondary Outcomes (1)
safety profile (changes in physical exam, laboratory measures, reported adverse events)
4 weeks +
Study Arms (10)
AEB1102 Dose Escalation Cohort 1
EXPERIMENTAL3 patients dosed at 0.01 mg/kg until MTD determined
AEB1102 Dose Escalation Cohort 2
EXPERIMENTAL4 patients dosed at 0.02 mg/kg until MTD determined
AEB1102 Dose Escalation Cohort 3
EXPERIMENTAL4 patients dosed at 0.04 mg/kg until MTD determined
AEB1102 Dose Escalation Cohort 4
EXPERIMENTAL4 patients dosed at 0.08 mg/kg until MTD determined
AEB1102 Dose Escalation Cohort 5
EXPERIMENTAL3 patients dosed at 0.12 mg/kg until MTD determined
AEB1102 Dose Escalation Cohort 6
EXPERIMENTAL4 patients dosed at 0.18 mg/kg until MTD determined
AEB1102 Dose Escalation Cohort 7
EXPERIMENTAL5 patients dosed at 0.27 mg/kg until MTD determined
AEB1102 Dose Escalation Cohort 8
EXPERIMENTAL7 patients dosed at 0.40 mg/kg until MTD determined
AEB1102 Dose Escalation Cohort 9
EXPERIMENTAL7 patients dosed at 0.33 mg/kg until MTD determined MTD determined at 0.33 mg/kg
AEB1102 Expansion
EXPERIMENTALUveal: 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
Interventions
Administered IV
Eligibility Criteria
You may qualify if:
- 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
- +2 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Pinnacle Research
Phoenix, Arizona, 85258, United States
UCLA
Los Angeles, California, 90024, United States
University of Colorado
Aurora, Colorado, 80045, United States
Research Center: Mid Florida Hematology/Oncology Centers
Orange City, Florida, 32763, United States
Dana Farber
Boston, Massachusetts, 02114, United States
Massachusetts General
Boston, Massachusetts, 02114, United States
Washington University
St Louis, Missouri, 93110, United States
Columbia University
New York, New York, 10032, United States
Providence Cancer Center
Portland, Oregon, 97213, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232, United States
UTSW
Dallas, Texas, 75390-8852, United States
Study Officials
- STUDY DIRECTOR
Jim Joffrion
Aeglea Biotherapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2015
First Posted
September 28, 2015
Study Start
October 1, 2015
Primary Completion
May 1, 2019
Study Completion
May 1, 2019
Last Updated
November 5, 2021
Record last verified: 2021-11