AU-007 for Advanced Cancer

Recruiting at 22 trial locations

Overseen By Jim Vasselli, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Aulos Bioscience, Inc.

Must not be taking: Immune-suppressive drugs

Disqualifiers: Autoimmune disease, Major surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 32

159 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, AU-007, for individuals with advanced solid tumors, such as certain skin and lung cancers. The trial aims to assess the safety and effectiveness of AU-007, both alone and in combination with other drugs like aldesleukin (a type of immunotherapy), avelumab, or nivolumab. Eligible participants have cancer that has either spread or cannot be surgically removed and have already tried other treatments without success. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot take more than 10 mg per day of prednisone (a type of steroid) or other immune-suppressive drugs within 7 days before starting the study drug. Hormones for non-cancer-related conditions like insulin for diabetes are allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that AU-007 is well-tolerated. This monoclonal antibody targets interleukin-2 (IL-2), a protein that can help fight cancer. When used alone, AU-007 demonstrated early signs of safety with manageable side effects.

When combined with aldesleukin, another immune-boosting treatment, AU-007 also remained safe. Patients managed the combination well, with side effects that were not too severe.

The safety profile stayed consistent when AU-007 was combined with other drugs like avelumab or nivolumab. These combinations showed that most side effects were manageable for patients.

Overall, research suggests that AU-007, whether used alone or with other treatments, is generally safe for humans. However, as this trial is still in the early stages, a fuller understanding of its safety may emerge as more participants join the studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about AU-007 for advanced cancer because it offers a novel approach by targeting IL-2 pathways in a unique way. Unlike traditional cancer therapies that might focus solely on tumor cells, AU-007 is designed to harness the body's immune response more effectively. This treatment is being explored in various combinations, including with aldesleukin, avelumab, and nivolumab, each aiming to enhance immune activation against cancer cells. The potential for AU-007 to work synergistically with these agents could lead to more robust and sustained anti-tumor effects, offering new hope for patients who have limited options with existing treatments.

What evidence suggests that this trial's treatments could be effective for advanced cancer?

Research has shown that AU-007 effectively targets advanced solid tumors. Some patients experienced partial or complete tumor shrinkage, even after other treatments failed. In this trial, participants may receive AU-007 combined with aldesleukin, a drug that boosts the immune system and has shown promising results with manageable side effects. Other participants may receive AU-007 in combination with either avelumab or nivolumab, drugs that help the immune system fight cancer, leading to positive outcomes, especially in challenging cases like melanoma. Overall, these findings suggest that AU-007 could be a promising treatment for advanced cancers. ^{3 5 6 7 8}

Who Is on the Research Team?

James Vasselli, MD

Principal Investigator

Aulos Bioscience, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors who've tried standard treatments without success, can't tolerate them, or have refused them. They must not be pregnant and agree to use contraception. Those previously treated with immune checkpoint inhibitors need resolved side effects except controlled hypothyroidism.

Inclusion Criteria

My brain metastases have been treated and I've had no symptoms for over 14 days.

I am a male and will use contraception, and ensure my partner does too, while on AU-007 and for 60 days after.

My cancer can be measured or seen on scans.

Exclusion Criteria

I am experiencing hair loss.

I haven't taken more than 10 mg of prednisone or similar drugs in the last week.

I have had an ongoing inflammation for more than 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of AU-007, with or without aldesleukin, to determine the recommended phase 2 dose (RP2D) or maximum tolerated dose (MTD)

Varies

Every 2 weeks (Q2w)

Cohort Expansion

Evaluate the initial efficacy of the RP2D from dose escalation in selected solid tumor types

Varies

Every 2 weeks (Q2w)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

End of treatment (EOT) visit 28 days after last dose

What Are the Treatments Tested in This Trial?

Interventions

• Aldesleukin
• AU-007

Trial Overview

The study tests AU-007 alone or combined with aldesleukin in patients with unresectable locally advanced or metastatic cancer. It's a Phase 1/2 trial assessing safety, tolerability, and initial effectiveness of the drugs administered every two weeks.

How Is the Trial Designed?

Group I: AU-007 plus aldesleukin in combination with nivolumab Experimental Treatment 3 Interventions

AU-007 (Q2w) administered in combination with a single dose of aldesleukin with the initial AU-007 dose. Nivolumab will be administered Q4w.

Group II: AU-007 plus aldesleukin in combination avelumab Experimental Treatment 3 Interventions

AU-007 and avelumab administered Q2w with a single dose of aldesleukin with the initial AU-007 dose

Group III: AU-007 combined with aldesleukin given concomitantly Experimental Treatment 2 Interventions

AU-007 administered in combination with aldesleukin, both administered Q2w (Complete; no longer enrolling)

Group IV: AU-007 combined with a single dose of aldesleukin Experimental Treatment 2 Interventions

AU-007 (Q2w) administered in combination with a single dose of aldesleukin with the initial AU-007 dose.

Group V: AU-007 Monotherapy Experimental Treatment 1 Intervention

AU-007 (Q2w) administered as a monotherapy sequential ascending doses with each Dose Escalation Cohort (Complete; no longer enrolling)

Who Is Running the Clinical Trial?

Aulos Bioscience, Inc.

Lead Sponsor

Trials

1

Recruited

160+

Published Research Related to This Trial

Ramucirumab, when combined with gold nanoparticles, significantly enhances the uptake and anticancer effects against advanced gastric cancer, surpassing the efficacy of either treatment alone.

The mechanism of this enhanced effect is primarily due to Ab-mediated phagocytosis, which is facilitated by the up-regulation of specific receptors in cancer cells, suggesting a promising avenue for future clinical applications of gold nanomaterials in cancer therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gold nanoparticles enhance antibody effect through direct cancer cell cytotoxicity by differential regulation of phagocytosis. Fan, L., Wang, W., Wang, Z., et al.[2023]

Gold nanoparticles (AuNPs) significantly enhance the effectiveness of cancer treatments, showing a dose enhancement factor greater than 12, which indicates a strong radiosensitizing effect, particularly through the upregulation of the Noxa gene.

In a study using MCF-7 breast cancer cells, combining AuNPs with ionizing radiotherapy and phototherapy resulted in better anti-proliferative effects by differentially regulating pro-apoptotic markers Bim and Noxa, leading to a significant reduction in cell viability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiosensitizing and Phototherapeutic Effects of AuNPs are Mediated by Differential Noxa and Bim Gene Expression in MCF-7 Breast Cancer Cell Line. Nakhla, S., Rahawy, A., Salam, MAE., et al.[2021]

Gold (Au-197) nanoparticles can be safely used to enhance the absorbed dose during radiation therapy for prostate cancer, as shown by Monte Carlo simulations.

The study found that using Au-197 with Sm-153 increased the absorbed dose rate in the entire prostate volume by 3% while reducing the undesirable dose in the exterior of the prostate by 7%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Au-197 nanoparticles along with Sm-153 radiopharmaceutical in prostate cancer from simulation method. Abbasi, A., Sadikoglu, F., Hassanzadeh, M.[2022]

Gold(III) meso-tetraphenylporphyrin (gold-1a) has been shown to effectively prolong survival and inhibit metastasis in mice with nasopharyngeal carcinoma (NPC), indicating its potential as a cancer treatment.

In addition to extending survival, gold-1a significantly reduced tumor microvessel formation and inhibited the migration and invasion of human NPC cells in vitro, suggesting a mechanism of action that targets tumor growth and spread.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gold(III) porphyrin 1a inhibited nasopharyngeal carcinoma metastasis in vivo and inhibited cell migration and invasion in vitro. Lum, CT., Liu, X., Sun, RW., et al.[2010]

Gold(III) meso-tetraphenylporphyrin (gold-1a) significantly prolonged survival and reduced tumor growth in a mouse model of melanoma, indicating its potential as a treatment for this type of cancer.

The compound works by inducing necrosis and apoptosis in tumor tissues, as well as inhibiting angiogenesis by downregulating key genes involved in blood vessel formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gold(III) porphyrin 1a prolongs the survival of melanoma-bearing mice and inhibits angiogenesis. Lum, CT., Huo, L., Sun, RW., et al.[2019]

Citations

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aulosbio.com

aulosbio.com/aulos-bioscience-presents-new-phase-2-data-for-au-007-demonstrating-continued-strong-anti-tumor-activity-in-advanced-cancers-at-aacr-annual-meeting/

Aulos Bioscience Presents New Phase 2 Data for AU-007 ...

Data show clear evidence of anti-tumor activity and durable partial and complete responses in heavily pre-treated patients with tumors that progressed through ...

2.

targetedonc.com

targetedonc.com/view/au-007-appears-safe-and-effective-for-solid-tumors-phase-2-findings-show

AU-007 Appears Safe and Effective for Solid Tumors ...

AU-007, an interleukin (IL)-2-binding monoclonal antibody, demonstrated a tolerable and manageable safety profile with strong evidence of antitumor activity.

3.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.2527

Updated results of a phase 1/2 study of AU-007 ...

A melanoma patient (Arm 1B) who progressed on anti-CTLA-4 + anti-PD-1 therapy had a 48% decrease in target tumors; a small brain metastasis was ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05267626

NCT05267626 | Study of AU-007, A Monoclonal Antibody ...

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 ...

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aulosbio.com

aulosbio.com/strong-evidence-of-au-007s-anti-tumor-activity-in-advanced-solid-tumor-cancers-presented-at-society-for-immunotherapy-of-cancer-sitc-annual-meeting/

Strong Evidence of AU-007's Anti-Tumor Activity in ...

Patients with a Treg cell reduction greater than the median of 43% had longer PFS outcomes than those with a Treg cell reduction less than the ...

6.

aacrjournals.org

aacrjournals.org/cancerres/article/85/8_Supplement_2/CT178/761811/Abstract-CT178-AU-007-a-human-monoclonal-antibody

AU-007, a human monoclonal antibody (mAb) that binds to IL ...

AU-007 is a computationally designed mAb that binds interleukin-2 (IL-2) on its CD25 binding epitope. AU-007-bound IL-2 cannot bind trimeric ...

7.

aulosbio.com

aulosbio.com/aulos-bioscience-to-present-initial-safety-data-from-first-in-human-phase-1-2-clinical-trial-of-il-2-therapeutic-au-007-at-37th-society-for-immunotherapy-of-cancer-sitc-annual-meeting/

Aulos Bioscience Presents Safety Data of IL-2 Therapy AU- ...

Aulos is evaluating AU-007 in an open label, first-in-human Phase 1/2 clinical trial designed to assess the safety, tolerability, immunogenicity ...

8.

targetedonc.com

targetedonc.com/view/early-antitumor-activity-and-safety-seen-with-au-007-across-solid-tumors

Early Antitumor Activity and Safety Seen With AU-007 ...

AU-007 is well-tolerated and shows early evidence of antitumor activity when used as a monotherapy or in combination with low-dose, subcutaneous aldesleukin ...