AU-007 for Advanced Cancer

Recruiting in Palo Alto (17 mi)

+18 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Aulos Bioscience, Inc.

Must not be taking: Immune-suppressive drugs

Disqualifiers: Autoimmune disease, Major surgery, others

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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 is determined, AU-007 plus aldesleukin will also be administered with avelumab.

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.

What makes the drug AU-007 unique for treating advanced cancer?

AU-007 is unique because it involves the use of gold nanoparticles, which have been shown to enhance the effects of radiation therapy and induce direct cancer cell death through mechanisms like phagocytosis (a process where cells engulf particles). This approach is different from traditional cancer treatments that do not typically use gold nanoparticles to boost therapeutic effects. ^{1 2 3 4 5}

Research Team

James Vasselli, MD

Principal Investigator

Aulos Bioscience, Inc.

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Aldesleukin (Cytokine)
• AU-007 (Monoclonal Antibody)

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.

Participant Groups

Group I: AU-007 combined with an aldesleukin loading dose Experimental Treatment 2 Interventions

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

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

AU-007 will be administered in combination with aldesleukin, both administered Q2w.

Group III: AU-007 combined with aldesleukin and avelumab given concomitantly Experimental Treatment 3 Interventions

AU-007 and avelumab will be administered Q2w, with either a single loading dose or Q2w aldesleukin.

Group IV: AU-007 Monotherapy Experimental Treatment 1 Intervention

AU-007 (Q2w) will be administered as a monotherapy sequential ascending doses with each Dose Escalation Cohort

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Tennessee Oncology Nashville, TN

Carolina Biooncology Institute Huntersville, NC

Mayo Clinic Jacksonville Jacksonville, FL

University of Utah - Huntsman Cancer Center Salt Lake City, UT

More Trial Locations

Who Is Running the Clinical Trial?

Aulos Bioscience, Inc.

Lead Sponsor

Trials

1

Patients Recruited

160+

Findings from Research

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(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]

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]

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]

References

1. United States 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. [2021]

2. Ireland pubmed.ncbi.nlm.nih.gov

Gold(III) porphyrin 1a inhibited nasopharyngeal carcinoma metastasis in vivo and inhibited cell migration and invasion in vitro. [2010]

3. England pubmed.ncbi.nlm.nih.gov

Gold(III) porphyrin 1a prolongs the survival of melanoma-bearing mice and inhibits angiogenesis. [2019]

4. India pubmed.ncbi.nlm.nih.gov

Effect of Au-197 nanoparticles along with Sm-153 radiopharmaceutical in prostate cancer from simulation method. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Gold nanoparticles enhance antibody effect through direct cancer cell cytotoxicity by differential regulation of phagocytosis. [2023]