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

Conditions

• Advanced Solid Tumor
• Cutaneous Melanoma
• Metastatic Cancer
• Non-Small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• AU-007 — DRUG
  Monoclonal Antibody Targeting IL-2
• Aldesleukin — DRUG
  IL-2
• Avelumab — DRUG
  Monoclonal Antibody Targeting PD-L1
• Nivolumab — DRUG
  Monoclonal Antibody Targeting PD-1

Study Details

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.

Key Dates

Start date

Apr 4, 2022

Status verified

May 2026

Primary completion

Jun 12, 2026

Completion

Jun 12, 2026

Study Design

Enrollment

159 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: AU-007 Monotherapy
  AU-007 (Q2w) administered as a monotherapy sequential ascending doses with each Dose Escalation Cohort (Complete; no longer enrolling)
• Experimental: AU-007 combined with a single dose of aldesleukin
  AU-007 (Q2w) administered in combination with a single dose of aldesleukin with the initial AU-007 dose.
• Experimental: AU-007 combined with aldesleukin given concomitantly
  AU-007 administered in combination with aldesleukin, both administered Q2w (Complete; no longer enrolling)
• Experimental: AU-007 plus aldesleukin in combination avelumab
  AU-007 and avelumab administered Q2w with a single dose of aldesleukin with the initial AU-007 dose
• Experimental: AU-007 plus aldesleukin in combination with nivolumab
  AU-007 (Q2w) administered in combination with a single dose of aldesleukin with the initial AU-007 dose. Nivolumab will be administered Q4w.

Primary Outcome Measure

Evaluate the safety and tolerability of AU-007 [ Time Frame: Day 1 thru end of treatment (EOT) visit (28 days after last dose) ]

Central Contacts

• Jim Vasselli, MD
  (707) 758-6776
  [email protected]

Locations (11)

Find similar trials in Miami, FL

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