What is the mechanism of action of this treatment?

L-DOS47 increases the pH within the tumor microenvironment, enhancing the efficacy of chemotherapeutic agents like doxorubicin. Doxorubicin works by intercalating into DNA, inhibiting cancer cell replication. This combination is significant for pancreatic cancer patients as it targets cancer cells more effectively, potentially improving treatment outcomes and allowing for more personalized treatment plans.

What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as doxorubicin, are associated with side effects including myelosuppression, mucositis, alopecia, nausea, vomiting, and cardiotoxicity. Liposomal formulations of doxorubicin, like pegylated liposomal doxorubicin, aim to reduce cardiotoxicity and have side effects such as hypersensitivity reactions, hand-foot syndrome, and esophagitis. These side effects should be considered when evaluating treatment options.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, including combinations like gemcitabine with nab-paclitaxel, which have shown significant efficacy. Doxorubicin, known for its DNA intercalation mechanism, is used in various cancers but is not a standard first-line treatment for pancreatic cancer. However, studies are exploring its potential in combination therapies, such as with L-DOS47, which aims to enhance doxorubicin's efficacy by increasing tumor pH. These innovative approaches are still under investigation to determine their clinical applicability.

What other types of research exist?

Promising novel alternatives for pancreatic cancer treatment include DX-8951, a potent camptothecin analog with strong antitumor activity and effectiveness against CPT-11-resistant tumors, and LN19, a multikinase inhibitor that enhances sensitivity to gemcitabine and shows significant growth inhibition in pancreatic adenocarcinoma models.

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Anti-tumor antibiotic

L-DOS47 + Doxorubicin for Pancreatic Cancer

Phase 1 & 2

Waitlist Available

Led By Erkut Borazanci, MD

Research Sponsored by Helix BioPharma Corporation

Eligibility Criteria Checklist

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

Must have

One or more metastatic tumors measurable on computed tomography (CT) scan per RECIST version 1.1 and screening FDG-PET scan with maximum standardized uptake value (SUV max) ≥ 5.5 for at least one lesion consistent with pancreatic cancer

Acceptable renal function as defined by creatinine ≤1.5x institutional upper limits of normal, or calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal

Must not have

Patients with any evidence of uncontrolled brain metastases or carcinomatosis meningitis

Active, uncontrolled bacterial, viral, or fungal infections requiring systematic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening to end of cycle 2, where each treatment cycle is 28 days.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, L-DOS47, combined with an existing chemotherapy drug, doxorubicin, in patients with advanced pancreatic cancer who have already received treatment. The goal is to find a safe dose and see if this combination can effectively fight the cancer. L-DOS47 helps the immune system attack cancer cells, while doxorubicin kills them directly.

Who is the study for?

Adults with advanced pancreatic cancer who've had prior treatment can join. They need normal kidney, liver, and blood function, no serious heart issues or infections, and a life expectancy of at least 3 months. Participants must not be pregnant or nursing and agree to use contraception.

What is being tested?

The trial tests L-DOS47 combined with doxorubicin on patients with advanced pancreatic cancer to check safety, tolerability, and initial effectiveness against tumors measurable by scans.

What are the potential side effects?

Potential side effects may include reactions related to the immune system due to L-DOS47 and heart problems, nausea, hair loss from Doxorubicin. Specific side effects will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have at least one tumor from pancreatic cancer that shows up on scans and is active.

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My kidney function is within the required range.

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I am able to care for myself but may not be able to do active work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have uncontrolled brain cancer spread or meningitis.

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I do not have any ongoing serious infections needing treatment.

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I have severe heart issues, recent heart attack, or unstable heart rhythm.

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I have been diagnosed with HIV, hepatitis B, or hepatitis C.

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My heart's electrical activity tests show a QT interval longer than 480 milliseconds.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening to end of cycle 2, where each treatment cycle is 28 days.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening to end of cycle 2, where each treatment cycle is 28 days.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening to end of cycle 2, where each treatment cycle is 28 days. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Adverse events (as per CTCAE v. 5.0)

Number of complete plus partial responders as per RECIST version 1.1

Secondary study objectives

Carbohydrate antigen (CA) 19-9 biomarker level

Body Weight Changes

Proportion of patients expressing anti-L-DOS47 antibodies

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: L-DOS47 + doxorubicinExperimental Treatment2 Interventions

Patients will be recruited into escalating dosing cohorts of 3, 6 and 9 µg/kg of L-DOS47, with a minimum of 3 and a maximum of 6 patients per cohort. A fixed dose of intravenous doxorubicin \[20 mg/m2/week\] will be administered in combination with L-DOS47 across all cohorts.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

L-DOS47

2012

Completed Phase 2

~80

Doxorubicin

2012

Completed Phase 3

~8030

0 / 8Eligibility criteria met

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

L-DOS47 increases the pH within the tumor microenvironment, enhancing the efficacy of chemotherapeutic agents like doxorubicin. Doxorubicin works by intercalating into DNA, inhibiting cancer cell replication. This combination is significant for pancreatic cancer patients as it targets cancer cells more effectively, potentially improving treatment outcomes and allowing for more personalized treatment plans.