A Phase 1/2, First-in-Human, Open Label, Dose Escalation and Expansion Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer
Aulos Bioscience, Inc.
Summary
This is a first in human, open-label, multi-center Phase 1 / 2 study to evaluate the safety, tolerability, and initial efficacy of AU-007 in patients with advanced solid tumors. AU-007 will be administered either as a monotherapy, or in combination with a single loading dose of aldesleukin, or with both AU-007 and aldesleukin given every 2 weeks (Q2w). Once the recommended phase 2 dose (RP2D) of AU-007 plus aldesleukin was determined, (AU-007 Q2w plus a single loading dose of aldesleukin), AU-007 plus aldesleukin is also being administered with avelumab or nivolumab.
Description
This is a first in human, multicenter, open-label Phase 1-2 study evaluating the safety, tolerability, and initial efficacy of AU-007 with or without aldesleukin, in patients with unresectable locally advanced or metastatic cancer. Patients must either be ineligible for or have progressed on prior standard of care therapy. Part 1 consists of 3 escalation Arms, each starting with a single 1+2 escalation cohort followed by 3+3 escalation cohorts to define the RP2D or maximum tolerated dose (MTD). The study begins in Arm A evaluating escalating doses of AU-007 (Q2w) in sequential escalation coh…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Selected Inclusion Criteria: * Patients must have measurable disease as per RECIST v1.1 criteria and documented by CT and/or MRI * Part 2 includes but is not limited to: * Cutaneous melanoma that is either locally unresectable or metastatic: * BRAF wild type: progressed after receiving PD-1 containing therapy with or without an anti-CTLA-4 * BRAF mutation: patients who refused BRAF+MEK inhibitor * Must have objective progression after receiving at least two cycles of prior doublet therapy (anti-PD-1/anti-CTLA-4 or anti-PD-1/anti-LAG-3) * Radiographic progression ≥ 4 weeks prior to th…
Interventions
- DrugAU-007
Monoclonal Antibody Targeting IL-2
- DrugAldesleukin
IL-2
- DrugAvelumab
Monoclonal Antibody Targeting PD-L1
- DrugNivolumab
Monoclonal Antibody Targeting PD-1
Locations (18)
- Sylvester Comprehensive Cancer Center - MiamiMiami, Florida
- START MidwestGrand Rapids, Michigan
- Minnesota Oncology and Hematology PAMinneapolis, Minnesota
- Washington UniversitySt Louis, Missouri
- Atlantic Healthcare SystemMorristown, New Jersey
- Carolina Biooncology InstituteHuntersville, North Carolina