Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced Pancreatic Adenocarcinoma

NCT04983407 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: AVB500-PC-005
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 17

Brief Summary

This is a Phase 1b/2 study of batiraxcept (AVB-S6-500) designed to evaluate the safety and efficacy of batiraxcept in combination with nab-paclitaxel and gemcitabine in subjects with locally advanced, recurrent, or metastatic pancreatic adenocarcinoma as first line therapy. The phase 1b portion of the study is open label and patients will receive batiraxcept, nab-paclitaxel, and gemcitabine. The Phase 2 portion of the study is randomized, 2-arm, open-label study to compare efficacy and tolerability of batiraxcept, nab-paclitaxel, and gemcitabine versus nab-paclitaxel and gemcitabine as first line therapy.

Conditions

Pancreatic Adenocarcinoma

Keywords

locally advanced; recurrent; metastatic; pancreatic; exocrine; pancreas; adenocarcinoma

Outcome Measures

Primary Outcomes (3)

• Incidence of adverse events (AEs)

  Measured by the number of patients with AEs in Phase 1b portion of the study.

  12 months

• Anti-tumor activity of batiraxcept in combination with nab-paclitaxel and gemcitabine in Phase 1b portion of the study

  Measured by Objective Response Rate (ORR): Proportion of subjects who have a partial or complete response to therapy relative to baseline in Phase 1b portion of the study.

  12 months

• Anti-tumor activity of batiraxcept in combination with nab-paclitaxel and gemcitabine in Phase 2 portion of the study

  Measured by progression free survival (PFS) in patients receiving batiraxcept, nab-paclitaxel, and gemcitabine versus patients receiving nab-paclitaxel, and gemcitabine alone in Phase 2.

  30 months

Secondary Outcomes (9)

• Pharmacokinetics: AUC

  30 months

• Pharmacokinetics: Cmax

  30 months

• Pharmacokinetics: Tmax

  30 months

• Pharmacokinetics: t1/2

  30 months

• Pharmacodynamic marker assessment

  30 months

Study Arms (3)

Phase 1b: batiraxcept+ nab-paclitaxel and gemcitabine

EXPERIMENTAL

Up to three dose levels of bactiraxcept plus nab-paclitaxel and gemcitabine

Drug: batiraxcept; Drug: Nab paclitaxel; Drug: Gemcitabine

Phase 2: batiraxcept+ nab-paclitaxel and gemcitabine

EXPERIMENTAL

Drug: batiraxcept; Drug: Nab paclitaxel; Drug: Gemcitabine

Phase 2: nab-paclitaxel and gemcitabine alone

ACTIVE COMPARATOR

Drug: Nab paclitaxel; Drug: Gemcitabine

Interventions

batiraxcept DRUG

Batiraxcept is experimental drug

Also known as: AVB-S6-500

Phase 1b: batiraxcept+ nab-paclitaxel and gemcitabine; Phase 2: batiraxcept+ nab-paclitaxel and gemcitabine

Nab paclitaxel DRUG

Nab paclitaxel is active comparator

Also known as: Abraxane

Phase 1b: batiraxcept+ nab-paclitaxel and gemcitabine; Phase 2: batiraxcept+ nab-paclitaxel and gemcitabine; Phase 2: nab-paclitaxel and gemcitabine alone

Gemcitabine DRUG

Gemcitabine is active comparator

Phase 1b: batiraxcept+ nab-paclitaxel and gemcitabine; Phase 2: batiraxcept+ nab-paclitaxel and gemcitabine; Phase 2: nab-paclitaxel and gemcitabine alone

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older
• Histologically or cytologically confirmed pancreatic adenocarcinoma. Must have locally advanced, recurrent, or metastatic disease ineligible for curative intent treatment(s) and eligible for first line systemic treatment.
• Must have radiologic imaging with a computed tomography (CT) scan or magnetic resonance imaging (MRI) within 22 days of study entry
• Must have at least one measurable lesion according to RECIST 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Adequate gastrointestinal (GI), bone marrow, liver and kidney function
• Life expectancy minimum of \> 12 weeks
• Adequate recovery from surgery to Grade 1 or baseline with at least 28 days from time of major surgery

You may not qualify if:

• Received last dose of chemotherapy (neoadjuvant or adjuvant), surgery, or radiation treatment with curative intent within 6 months prior to study entry
• Islet-cell neoplasms
• Prior malignancy within the past 3 years except adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix, breast or melanoma
• Symptomatic uncontrolled central nervous system (CNS) metastasis or brain metastases unless adequately treated and controlled
• Evidence of clinically significant third spacing (e.g. pleural effusion, ascites, anasarca, etc.) within 28 days prior to study entry
• Serious active infection requiring IV antibiotics and/or hospitalization at study entry
• Active human immune deficiency (HIV) syndrome, hepatitis B, hepatitis C, or other active viral illness

Sponsors & Collaborators

• Aravive, Inc.: lead

Study Sites (17)

UCLA Health

Santa Monica, California, 90404, United States

Location

Boca Raton Regional Hospital / Lynn Cancer Institute

Boca Raton, Florida, 33486, United States

Location

Moffit Cancer Center

Tampa, Florida, 33612, United States

Location

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Michigan Medicine - University of Michigan

Ann Arbor, Michigan, 48108, United States

Location

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location

Perlmutter Cancer Center at NYU Langone Health

New York, New York, 10016, United States

Location

Duke University Medical Center (DUMC)

Durham, North Carolina, 27710, United States

Location

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University / Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, 19107, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

AHN Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Froedtert and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Recurrence; Neoplasm Metastasis; Adenocarcinoma

Interventions

Taxes; Albumin-Bound Paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Design

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

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 30, 2021
• Study Start: July 28, 2021
• Primary Completion: August 14, 2023
• Study Completion: August 14, 2023
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)