Safety And Efficacy Study Of AVB-S6-500 (Batiraxcept) In Patients With Advanced Pancreatic Adenocarcinoma

Study Overview

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

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.

N/A

Pancreatic Adenocarcinoma

DRUG: batiraxcept
DRUG: Nab paclitaxel
DRUG: Gemcitabine

AVB500-PC-005

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-07-08	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-10-26
First Submitted that Met QC Criteria 2021-07-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-10-30
First Posted (ACTUAL) 2021-07-30	Results First Posted N/A	Last Verified 2023-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Phase 1b: batiraxcept+ nab-paclitaxel and gemcitabine Up to three dose levels of bactiraxcept plus nab-paclitaxel and gemcitabine	DRUG: batiraxcept Batiraxcept is experimental drug DRUG: Nab paclitaxel Nab paclitaxel is active comparator DRUG: Gemcitabine Gemcitabine is active comparator
EXPERIMENTAL: Phase 2: batiraxcept+ nab-paclitaxel and gemcitabine	DRUG: batiraxcept Batiraxcept is experimental drug DRUG: Nab paclitaxel Nab paclitaxel is active comparator DRUG: Gemcitabine Gemcitabine is active comparator
ACTIVE_COMPARATOR: Phase 2: nab-paclitaxel and gemcitabine alone	DRUG: Nab paclitaxel Nab paclitaxel is active comparator DRUG: Gemcitabine Gemcitabine is active comparator

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Phase 1b: batiraxcept+ nab-paclitaxel and gemcitabine

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

DRUG: batiraxcept

Batiraxcept is experimental drug

DRUG: Nab paclitaxel

Nab paclitaxel is active comparator

DRUG: Gemcitabine

Gemcitabine is active comparator

EXPERIMENTAL: Phase 2: batiraxcept+ nab-paclitaxel and gemcitabine

DRUG: batiraxcept

Batiraxcept is experimental drug

DRUG: Nab paclitaxel

Nab paclitaxel is active comparator

DRUG: Gemcitabine

Gemcitabine is active comparator

ACTIVE_COMPARATOR: Phase 2: nab-paclitaxel and gemcitabine alone

DRUG: Nab paclitaxel

Nab paclitaxel is active comparator

DRUG: Gemcitabine

Gemcitabine is active comparator

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
Pharmacokinetics: AUC	Area under the batiraxcept concentration-time curve.	30 months
Pharmacokinetics: Cmax	Maximum observed batiraxcept concentration.	30 months
Pharmacokinetics: Tmax	Time of maximum observed batiraxcept concentration.	30 months
Pharmacokinetics: t1/2	Apparent terminal half-life of batiraxcept.	30 months
Pharmacodynamic marker assessment	Change from the baseline in GAS6 serum levels.	30 months
Anti-drug antibody (ADA) titers	Change from baseline in ADA titer.	30 months
Disease control rate	Proportion of subjects who have a complete or partial response to therapy or maintain stable disease.	30 months
Duration of response (DOR)	Measured from the date of partial or complete response to therapy until the cancer progresses.	30 months
Overall survival	Time following the treatment until death.	60 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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