Can a new drug tame advanced solid tumors?
NCT ID NCT02561234
First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This early-stage trial is testing an experimental drug called AEB1102 in people with advanced solid tumors that have not responded to standard treatments or for which no standard treatment exists. The main goal is to find the highest dose that is safe and to understand the drug's side effects. Participants receive the drug through an IV, and the study will monitor their health closely.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AEB1102 (Co-Arg1-PEG), an experimental drug given by IV infusion
- What this could lead to
- If it works, this could point toward a new treatment option for advanced solid tumors that have not responded to standard therapies.
- What could go wrong
- This is an early, first-in-human trial focused on safety and dosing, so it may not lead to an effective treatment. There are also potential side effects from the drug, which are being studied.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
76 people
The number who actually took part.
- Started
-
Oct 2015
- Finished
-
May 2019
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced cancers are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Columbia University
New York, New York, 10032, United States
-
Dana Farber
Boston, Massachusetts, 02114, United States
-
Massachusetts General
Boston, Massachusetts, 02114, United States
-
Pinnacle Research
Phoenix, Arizona, 85258, United States
-
Providence Cancer Center
Portland, Oregon, 97213, United States
-
Research Center: Mid Florida Hematology/Oncology Centers
Orange City, Florida, 32763, United States
-
UCLA
Los Angeles, California, 90024, United States
-
UTSW
Dallas, Texas, 75390-8852, United States
-
University of Colorado
Aurora, Colorado, 80045, United States
-
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232, United States
-
Washington University
St Louis, Missouri, 93110, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New PET tracer aims to light up hidden cancer targets
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Proton beams aimed at lung tumors while sparing the heart
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers