Advanced Cancers Clinical Trial
Official title:
A Multiple Dose, Dose Escalation Trial of AEB1102 (Co-ArgI-PEG) in Patients With Advanced Solid Tumors
Verified date | November 2021 |
Source | Aeglea Biotherapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 98 |
Est. completion date | May 2019 |
Est. primary completion date | May 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado | Aurora | Colorado |
United States | Dana Farber | Boston | Massachusetts |
United States | Massachusetts General | Boston | Massachusetts |
United States | UTSW | Dallas | Texas |
United States | UCLA | Los Angeles | California |
United States | Columbia University | New York | New York |
United States | Research Center: Mid Florida Hematology/Oncology Centers | Orange City | Florida |
United States | Pinnacle Research | Phoenix | Arizona |
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Providence Cancer Center | Portland | Oregon |
United States | Washington University | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Aeglea Biotherapeutics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | maximum tolerated dose | the dose level at which no more than 1/6 patients experiences dose-limiting toxicity | 4 weeks | |
Secondary | safety profile (changes in physical exam, laboratory measures, reported adverse events) | changes in physical exam, laboratory measures, reported adverse events | 4 weeks + |
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