What side effects are associated with this type of intervention?

Common side effects of cancer treatments similar to the AP160-complex, which includes nab-paclitaxel and STI-3031, involve a range of symptoms. Nab-paclitaxel, an antimicrotubule agent, often causes neutropenia, neuropathy, fatigue, and gastrointestinal issues such as nausea and diarrhea. Monoclonal antibodies like STI-3031 can lead to immune-related side effects including rash, diarrhea, and fatigue, as well as more severe reactions like infusion-related reactions and immune-mediated adverse effects.

What prior FDA approvals exist?

Nab-paclitaxel, an antimicrotubule agent, has been FDA-approved for the treatment of various cancers, including metastatic breast cancer, non-small cell lung cancer, and pancreatic cancer, often in combination with other chemotherapeutic agents like gemcitabine. Monoclonal antibodies, such as pembrolizumab and nivolumab, have also received FDA approval for their role in enhancing the immune system's ability to attack cancer cells. These treatments are used in various cancers, including melanoma, lung cancer, and head and neck cancers. The combination of these types of therapies aims to both inhibit tumor growth directly and boost the body's immune response against cancer.

What other types of research exist?

Promising novel alternatives to the AP160-complex for cancer patients include: 1) PARP inhibitors like olaparib for maintenance therapy in patients with germline BRCA or PALB2 pathogenic variants, particularly after initial platinum-based chemotherapy. 2) Immune checkpoint inhibitors such as anti-PD-1 or anti-PD-L1 therapies, which have shown efficacy in various cancers, including lung and small cell lung cancer. 3) Eribulin, which has demonstrated improved overall survival in patients with liposarcoma compared to dacarbazine. 4) Nab-sirolimus, suggested for advanced unresectable or metastatic malignant neoplasms with perivascular epithelioid cell differentiation (PEComa). These alternatives offer different mechanisms of action and may provide effective treatment options for cancer patients.

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Anti-microtubule Agent

AP160-Complex for Advanced Cancer

Phase 1

Recruiting

Led By Matthew S. Block, M.D., Ph.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the start of the treatment until disease progression/recurrence, assessed up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include those typical of chemotherapy such as nausea, hair loss, fatigue, increased risk of infection; plus immunotherapy-related reactions like allergies or autoimmune-like symptoms where the body attacks its own cells.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the start of the treatment until disease progression/recurrence, assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the start of the treatment until disease progression/recurrence, assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of the treatment until disease progression/recurrence, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximally tolerated dose (MTD)

Secondary study objectives

Best response

Incidence of adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (AP160-complex)Experimental Treatment5 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~1090

Biospecimen Collection

2004

Completed Phase 3

~2020

Computed Tomography

2017

Completed Phase 2

~2740

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common cancer treatments include antimicrotubule agents like nab-paclitaxel and monoclonal antibodies like STI-3031. Nab-paclitaxel works by stabilizing microtubules, which are essential for cell division, thereby stopping the growth and spread of tumor cells. Monoclonal antibodies, such as STI-3031, help the immune system recognize and attack cancer cells and can also inhibit pathways that tumors use to grow and spread. These mechanisms are crucial for cancer patients as they target the cancer cells directly, potentially leading to better treatment outcomes and prolonged survival. Other common treatments include chemotherapy, which kills rapidly dividing cells, and targeted therapies that inhibit specific molecules involved in cancer growth.

Stathmin 1 is highly expressed and associated with survival outcome in malignant adrenocortical tumours.Augmentation of response to nab-paclitaxel by inhibition of insulin-like growth factor (IGF) signaling in preclinical pancreatic cancer models.Targeting the platelet-derived growth factor receptor in antivascular therapy for human ovarian carcinoma.