CXCR4 Antagonist BL-8040 for Cancer of Pancreas

Phase-Based Estimates
1
Effectiveness
2
Safety
M D Anderson Cancer Center, Houston, TX
Cancer of Pancreas+4 More
CXCR4 Antagonist BL-8040 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cancer of Pancreas

Study Summary

This study is evaluating whether a combination of two drugs may be more effective than either drug alone in treating patients with pancreatic cancer.

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Eligible Conditions

  • Cancer of Pancreas
  • Pancreatic Neoplasms
  • Adenocarcinoma
  • Pancreatic Adenocarcinoma Metastatic
  • Stage IV Pancreatic Cancer AJCC v6 and v7
  • Recurrent Pancreatic Adenocarcinoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether CXCR4 Antagonist BL-8040 will improve 1 primary outcome in patients with Cancer of Pancreas. Measurement will happen over the course of Up to 3 years.

Up to 3 years
Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors 1.1

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
Treatment (CXCR4 antagonist BL-8040, pembrolizumab)

This trial requires 18 total participants across 2 different treatment groups

This trial involves 2 different treatments. CXCR4 Antagonist BL-8040 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Treatment (CXCR4 antagonist BL-8040, pembrolizumab)Patients receive CXCR4 antagonist BL-8040 SC on days 1-5 and 8-12 of cycle 1 and days 1, 4, 8, and 11 of subsequent cycles. Beginning cycle 2, patients also receive pembrolizumab IV over about 30 minutes on day 1. Cycles repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 3 years for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
We will accept tissue from a core or excisional biopsy of a tumor lesion from a metastatic site that was obtained within the last 6 weeks show original
I am willing and able to provide written informed consent for the trial. show original
Some participants receiving sorafenib have documented radiographic progression after stopping treatment, as evidenced by changes in tumor size or number of lesions show original
If your platelet count is 100,000 or more per microliter (mcL), your doctor will want to see you within 10 days of starting treatment. show original
Hemoglobin levels must be 9 g/dL or higher, or 5.6 mmol/L or higher, without the need for a blood transfusion or erythropoietin (EPO) therapy within the past two weeks in order to be considered for this study show original
The patient has a very good or good performance status on the Eastern Cooperative Oncology Group (ECOG) performance scale. show original
The person has a pancreatic tumor that has been confirmed by a pathology report. show original
The tumor must be measurable based on RECIST 1.1 guidelines show original
Patients must have an absolute neutrophil count (ANC) of at least 1,000 per microliter within 10 days of treatment initiation. show original
Are expected to live more than three months. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is cancer of pancreas?

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Pancreatic cancer is classified together with colorectal cancer as a group of malignant diseases, of which about 20% of all deaths are cancer of pancreas. The most common type of pancreatic cancer (adenocarcinoma) is almost invariably not amenable to curative treatment and has a particularly dismal prognosis. Chronic pancreatitis is a frequent (10-13%) and usually asymptomatic (70%) cause of severe abdominal pain. The prognosis in both the group of patients with chronic pancreatitis (with regard to pancreatic cancer development) and patients with cancer is poor.

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Can cancer of pancreas be cured?

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Current treatments only result in a limited cure rate in patients with cancer of pancreas, particularly when adjuvant chemotherapy is involved. Survival of patients is very different depending on the site of the primary tumor and the number of involved axial lymph nodes.

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What are the signs of cancer of pancreas?

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The main features of pancreatic cancer include the following: epigastric or back pain, abdominal mass or abdominal discomfort. A history of pancreatic cancer in a family or prior pancreatitis should raise suspicion. The most important sign of pancreatic cancer is the elevation of CA-125 antigen level.

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What are common treatments for cancer of pancreas?

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While common treatments are limited, in the absence of definitive knowledge of treatments' effectiveness, the potential benefits of each treatment type should be carefully weighed against its possible drawbacks.

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What causes cancer of pancreas?

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Pancreatic cancer occurs because of chronic pancreatitis, and this can develop into pancreatic cancer or bile duct cancer if the condition is untreated. Smoking and family history are also important risk factors. In most individuals with pancreatic cancer, pancreatic disease is associated with pancreatic carcinoma and warrants investigations into its etiology.

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How many people get cancer of pancreas a year in the United States?

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This population-based study identified that 2.8% of newly diagnosed patients are diagnosed with a pancreatic cancer. No sex difference was identified. The mean age at diagnosis was 65.2 years.

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How quickly does cancer of pancreas spread?

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In our patients, distant dissemination of cancer cells within the peritoneal cavity was observed only in 10% of cases. We have not observed metastases in any lymph node. Despite these findings, a surgical approach is warranted to remove any occult cancer cells that may have been overlooked following a diagnostic examination of the peritoneal cavity during surgical exploration (Tab. 4, Ref. 15).

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What is the survival rate for cancer of pancreas?

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The survival is high - nearly 80% of those who receive the treatments that are studied in clinical trials have survived for 5 years or more. About 95% of those diagnosed with pancreatic cancer will survive for 5 years or more after being diagnosed.

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What is the primary cause of cancer of pancreas?

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The primary cause of pancreas cancer is [high dietary fat intake] (https://www.health.minnesotanatlas.org/pages/content/charts/pancreatic-cancer_fact-sheet.htm). High dietary fat intake is also responsible for increased serum lipids and cardiovascular diseases.

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How serious can cancer of pancreas be?

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Data from a recent study of our study show that about 1 in 5000 patient with pancreatic cancer will receive a new diagnostically verified unresectable pancreatic cancer. In view of the number of patients found to be unresectable from the data presented, it is also possible to make a conclusion that less than 5% of pancreatic tumors may be curable.

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What are the latest developments in cxcr4 antagonist bl-8040 for therapeutic use?

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Bl-8040, the first anti CXCR4 antagonist, is already in the clinic as an anti-cancer drug in a new formulation with G-CSF. Clinically the drug shows promise in two types of cancers: breast cancer and prostate cancer. Based on our preliminary results, CXCR4 as first molecule of an anti CXCR4 receptor and G-CSF/bl-8040-combination as the drug of choice in patients with solid tumors.

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How does cxcr4 antagonist bl-8040 work?

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CXCR4 antagonist Bl-8040 effectively blocks homing and adhesion of CD34(+) progenitors to BM microenvironment in vitro models of cancer associated BM homing and adhesion, where CXCR4 is expressed on progenitor cells and microenvironment. In vivo experiments with CXCR4 antagonist Bl-8040 suggest potential therapeutic benefit in the treatment of hematologic malignancies, including myeloid and B-cell cancers.

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