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

Completed · Phase 1

Conditions studied: Advanced Cancers

In brief

A first-in-human study of the safety of increasing dose levels of AEB1102 in patients with advanced cancers.

Key facts

Study ID

NCT02561234

Run by

Immedica Pharma AB

People needed

76

Starts

2015-10-22

Expected to finish

2019-05-28

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Small Cell Lung Cancer:
• extensive disease previously treated with, or inability to tolerate, platinum-based chemotherapy

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

Where it is running

• Pinnacle Research — Phoenix, Arizona, United States
• UCLA — Los Angeles, California, United States
• University of Colorado — Aurora, Colorado, United States
• Research Center: Mid Florida Hematology/Oncology Centers — Orange City, Florida, United States
• Dana Farber — Boston, Massachusetts, United States
• Massachusetts General — Boston, Massachusetts, United States
• Washington University — St Louis, Missouri, United States
• Columbia University — New York, New York, United States
• Providence Cancer Center — Portland, Oregon, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• UTSW — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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