Nab-Paclitaxel/STI-3031 Complex (AP160-Complex) for the Treatment of Advanced or Metastatic Solid Tumors

NCT05653661 | Withdrawn Phase 1 DMC FDA Drug

• 3 other identifiers: MC210104NCI-2022-0924822-000906
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial tests the safety, side effects, and best dose of a new drug called nab-paclitaxel/STI-3031 complex (AP160-complex) in treating patients with solid tumors that may have spread from where they first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that have spread from where they first started (primary site) to other distant parts of the body (metastatic). AP160-complex is a combination of the chemotherapy drug nab-paclitaxel, and the immunotherapy drug STI-3031. Nab-paclitaxel is in a class of medications called antimicrotubule agents. It works by stopping the growth and spread of tumor cells. Immunotherapy with monoclonal antibodies, such as STI-3031, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. AP160-complex may work better than standard therapies in treating advanced or metastatic solid tumors.

Conditions

Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; Unresectable Melanoma

Outcome Measures

Primary Outcomes (1)

• Maximally tolerated dose (MTD)

  MTD is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients).

  Up to 28 days (Cycle 1)

Secondary Outcomes (2)

• Incidence of adverse events

  Up to 90 days after last dose of AP160-complex

• Best response

  From the start of the treatment until disease progression/recurrence, assessed up to 2 years

Study Arms (1)

Treatment (AP160-complex)

EXPERIMENTAL

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.

Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Drug: Nab-paclitaxel/Danburstotug Complex AP160

Interventions

Biopsy PROCEDURE

Undergo tissue biopsies

Also known as: BIOPSY_TYPE, Bx

Treatment (AP160-complex)

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (AP160-complex)

Computed Tomography PROCEDURE

Undergo CT scans

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

Treatment (AP160-complex)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI scans

Also known as: Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Treatment (AP160-complex)

Nab-paclitaxel/Danburstotug Complex AP160 DRUG

Given IV

Also known as: AP 160, AP-160, AP160, Nab-paclitaxel/STI-3031 Complex AP160

Treatment (AP160-complex)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent
• PRE-REGISTRATION
• Age \>= 18 years
• Willingness to provide mandatory pre-registration tissue specimen for research
• At least one prior systemic therapy in the metastatic setting (adjuvant or neoadjuvant therapy not included).
• NOTE: There is no upper limit to the number of prior treatment regimens
• Dose Escalation Cohort Only
• Patients with histologically or cytologically confirmed advanced or metastatic non-neurological solid tumors, who have no curative or life prolonging therapeutic options
• Melanoma Dose Expansion Cohort Only
• Histologic proof of surgically unresectable stage IV malignant melanoma
• Disease progression on or after anti-PD1/PDL1 antibody-based therapy in the metastatic setting (adjuvant or neoadjuvant therapy with anti-PD1/PDL1 antibody do not count)
• REGISTRATION
• Tissue submitted for testing at pre-registration shows minimal level of tumor staining for PDL1 (clinical test using 22c3 immunohistochemistry) demonstrating tumor staining in \>= 1% of tumor cells
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2
• Hemoglobin \>= 9.0 g/dL (patients may be transfused to meet hemoglobin \[Hgb\] requirement) (obtained =\< 14 days prior to registration)

You may not qualify if:

• Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown:
• Pregnant persons
• Nursing persons
• Persons of childbearing potential {and persons able to father a child} who are unwilling to employ adequate contraception
• Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy
• Any anti-cancer therapy or investigational agents =\< 4 weeks prior to registration
• Failure to recover from prior surgery
• Failure to fully recover from acute, reversible effect of prior chemotherapy regardless of interval since last treatment
• Anti-PD(L)1 antibody =\< 4 weeks prior to registration
• Previous grade 4 irAEs from immune checkpoint inhibitor antibody therapy
• Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy
• NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
• Uncontrolled intercurrent illness including, but not limited to:
• ongoing or active infection

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Biopsy; Specimen Handling; Magnetic Resonance Spectroscopy; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Matthew S. Block, MD, PhD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 16, 2022
• Study Start: July 30, 2024
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Locations

US (1)