AP160-Complex for Advanced Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Matthew S. Block, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new drug combination in patients with serious cancer. The treatment aims to stop cancer cell growth and boost the immune system to fight the cancer.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not have received any anti-cancer therapy or investigational agents within 4 weeks prior to registration, and you must be off systemic corticosteroids for at least 2 weeks before registration, unless you are on a low dose for chronic conditions. It's best to discuss your specific medications with the trial team.

What data supports the idea that AP160-Complex for Advanced Cancer is an effective drug?

The available research shows that AP160-Complex for Advanced Cancer, also known as nab-paclitaxel, is effective in treating several types of cancer. For instance, it has been shown to improve outcomes in patients with non-small-cell lung cancer (NSCLC) and metastatic breast cancer. In NSCLC, studies have demonstrated that nab-paclitaxel can increase the concentration of the active drug in tumors, which may lead to better treatment results. Additionally, it is approved for use in metastatic breast cancer in both Europe and the US, indicating its recognized effectiveness. Compared to traditional solvent-based paclitaxel, nab-paclitaxel avoids certain toxicities and does not require premedication to prevent infusion-related reactions, making it a safer and more convenient option for patients.

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What safety data is available for nab-paclitaxel?

Nab-paclitaxel, also known as ABI-007, is a solvent-free, albumin-bound formulation of paclitaxel designed to avoid toxicities associated with solvent-based paclitaxel. It has been evaluated in various studies for its safety and efficacy. It is approved for metastatic breast cancer in Europe and the US, and for non-small-cell lung cancer and advanced pancreatic cancer in the US. Studies have shown improved tolerability compared to solvent-based paclitaxel, and trials have determined the maximum-tolerated dose and assessed its pharmacokinetics in different cancer types.

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Is the drug nab-paclitaxel a promising treatment for advanced cancer?

Yes, nab-paclitaxel is a promising drug for advanced cancer. It is a new form of paclitaxel that doesn't use harmful solvents, making it safer and more effective. It has shown better results and fewer side effects in treating breast cancer and is approved for use in other cancers like lung and pancreatic cancer.

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Eligibility Criteria

This trial is for adults with advanced or metastatic solid tumors, including melanoma, who have already tried at least one systemic therapy. Participants must provide consent and a tissue sample for research. There's no limit to prior treatments but the cancer should be non-neurological and without curative options.

Inclusion Criteria

My melanoma cannot be removed with surgery and is stage IV.

Absolute neutrophil count (ANC) >= 1500/mm^3 (obtained =< 14 days prior to registration)

For persons of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for 6 months after the last dose of study treatment

Exclusion Criteria

I am not willing to use birth control during the study.

I have not fully recovered from my last surgery.

I have had a severe reaction to immune therapy before.

Participant Groups

The trial tests the safety and optimal dose of AP160-complex, a new drug combining chemotherapy (nab-paclitaxel) and immunotherapy (STI-3031). It aims to see if this complex can better halt tumor growth compared to standard therapies in patients with advanced or metastatic solid tumors.

Group I: Treatment (AP160-complex) Experimental Treatment 5 Interventions

Patients receive AP160-complex IV on study. Patients in the dose-escalation cohort undergo computed tomography/magnetic resonance imaging (MRI) scans, tissue biopsies, and collection of blood samples throughout the trial. Patients in the dose-expansion cohort undergo MRI scan during screening, collection of blood samples during screening and on study, and tissue biopsies throughout the trial.

Nab-paclitaxel is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Abraxane for:

• Metastatic breast cancer
• Non-small cell lung cancer
• Adenocarcinoma of the pancreas

🇪🇺 Approved in European Union as Abraxane for:

• Metastatic breast cancer
• Non-small cell lung cancer
• Adenocarcinoma of the pancreas

🇨🇦 Approved in Canada as Abraxane for:

• Metastatic breast cancer
• Non-small cell lung cancer
• Adenocarcinoma of the pancreas

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mayo Clinic in Rochester Rochester, MN

Who Is Running the Clinical Trial?

Mayo Clinic Lead Sponsor

National Cancer Institute (NCI) Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

Randomized crossover pharmacokinetic study of solvent-based paclitaxel and nab-paclitaxel. [2022] Abraxane (ABI-007) is a 130-nm albumin-bound (nab) particle formulation of paclitaxel, devoid of any additional excipients. We hypothesized that this change in formulation alters the systemic disposition of paclitaxel compared with conventional solvent-based formulations (sb-paclitaxel; Taxol), and leads to improved tolerability of the drug.

2. England pubmed.ncbi.nlm.nih.gov

A phase II study of nab-paclitaxel in combination with ramucirumab in patients with previously treated advanced gastric cancer. [2023] Nanoparticle albumin-bound (nab)-paclitaxel was developed to improve paclitaxel solubility and does not need premedication to avoid infusion-related reactions associated with solvent-based (sb)-paclitaxel. We conducted a phase II trial to investigate the efficacy and safety of nab-paclitaxel plus ramucirumab combination therapy for previously treated advanced gastric cancer.

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

Safety and efficacy evaluation of albumin-bound paclitaxel. [2015] Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is a novel solvent-free formulation of paclitaxel, which was developed to avoid toxicities associated with Cremophor EL® vehicle used in solvent-based paclitaxel. It is approved as monotherapy for treatment of metastatic breast cancer (MBC) in Europe and the US; in combination therapy for non-small-cell lung cancer (NSCLC) and for first-line treatment of advanced pancreatic cancer (PC) only in the US. The European Medicines Agency has recently released only a positive opinion for use of nab-paclitaxel in PC.

4. England pubmed.ncbi.nlm.nih.gov

Abraxane, a novel Cremophor-free, albumin-bound particle form of paclitaxel for the treatment of advanced non-small-cell lung cancer. [2022] Abraxane (ABI-007) is a novel 130-nm, albumin-bound (nab) particle form of paclitaxel designed to utilize endogenous albumin pathways to increase intratumor concentrations of the active drug. This multicenter phase II study was designed to evaluate the efficacy and safety of Abraxane 260 mg/m2 every 3 weeks in patients with non-small-cell lung cancer (NSCLC).

5. United States pubmed.ncbi.nlm.nih.gov

Phase I/II trial of weekly intravenous 130-nm albumin-bound paclitaxel as initial chemotherapy in patients with stage IV non-small-cell lung cancer. [2015] Nanoparticle albumin-bound paclitaxel (NAB-paclitaxel) is an albumin-bound formulation of paclitaxel that has demonstrated improved efficacy compared with paclitaxel in the treatment of metastatic breast cancer. We undertook this trial to determine the maximum-tolerated dose (MTD) and single-agent activity of NAB-paclitaxel administered on a weekly basis to patients with stage IV non-small-cell lung cancer (NSCLC).

6. United States pubmed.ncbi.nlm.nih.gov

Phase I and pharmacokinetics trial of ABI-007, a novel nanoparticle formulation of paclitaxel in patients with advanced nonhematologic malignancies. [2022] ABI-007 is a novel solvent-free, albumin-bound, 130-nm particle formulation of paclitaxel designed to avoid solvent-related toxicities and to deliver paclitaxel to tumors via molecular pathways involving an endothelial cell-surface albumin receptor (gp60) and an albumin-binding protein expressed by tumor cells and secreted into the tumor interstitium (secreted protein acid rich in cysteine). This study determined the maximum-tolerated dose (MTD) of ABI-007 monotherapy administered weekly (three weekly doses, repeated every 4 weeks) and assessed the pharmacokinetics of paclitaxel administered as ABI-007.

7. United States pubmed.ncbi.nlm.nih.gov

Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. [2023] ABI-007, the first biologically interactive albumin-bound paclitaxel in a nanameter particle, free of solvents, was compared with polyethylated castor oil-based standard paclitaxel in patients with metastatic breast cancer (MBC). This phase III study was performed to confirm preclinical studies demonstrating superior efficacy and reduced toxicity of ABI-007 compared with standard paclitaxel.

8. United States pubmed.ncbi.nlm.nih.gov

Multicenter phase II trial of ABI-007, an albumin-bound paclitaxel, in women with metastatic breast cancer. [2022] ABI-007 is a novel nanoparticle, albumin-bound paclitaxel that is free of solvents. This multicenter phase II study was designed to evaluate the efficacy and safety of ABI-007 for the treatment of metastatic breast cancer (MBC).