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Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · September 18, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1/2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT05267626). This is a study registration, not published results. Lead sponsor: Aulos Bioscience, Inc.. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 159 participants (ESTIMATED). Conditions: Advanced Solid Tumor, Metastatic Cancer, Cutaneous Melanoma, Non-Small Cell Lung Cancer. Interventions: DRUG: AU-007; DRUG: Aldesleukin; DRUG: Avelumab; DRUG: Nivolumab. Primary outcome measures: Evaluate the safety and tolerability of AU-007 , Day 1 thru end of treatment (EOT) visit (28 days after last dose); Establish the maximum tolerated dose (MTD) and/or RP2D , Day 1 thru EOT visit (28 days after last dose). Brief 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, also known as imneskibart, 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.