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Anti-tumor antibiotic

L-DOS47 + Doxorubicin for Pancreatic Cancer

Phase 1 & 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening to end of cycle 2, where each treatment cycle is 28 days.
Awards & highlights

Study Summary

This trial will test a new combination therapy for advanced pancreatic cancer. The goal is to see if it is safe and better than current treatments.

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.Check my eligibility
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.See study design
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
Select...
I have at least one tumor from pancreatic cancer that shows up on scans and is active.
Select...
My kidney function is within the required range.
Select...
I am able to care for myself but may not be able to do active work.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse events (as per CTCAE v. 5.0)
Number of complete plus partial responders as per RECIST version 1.1
Secondary outcome measures
Carbohydrate antigen (CA) 19-9 biomarker level
Body Weight Changes
Proportion of patients expressing anti-L-DOS47 antibodies

Side effects data

From 2015 Phase 2 trial • 32 Patients • NCT01205503
47%
Anemia
41%
Nausea
31%
Lymphocyte count decreased
28%
Fatigue
28%
White blood cell decreased
28%
Neutrophil count decreased
13%
Platelet count decreased
13%
Headache
13%
Hypoatremia
13%
Constipation
13%
Paresthesia
9%
Cough
9%
Alanine aminotransferase increased
9%
Hypocalcemia
9%
Hypokalemia
9%
Myalgia
9%
Vomiting
9%
Hypoalbuminemia
6%
Dyspnea
6%
Febrile neutropenia
6%
Hypernatremia
6%
Edema Limbs
6%
Mucositis oral
6%
Pain
6%
Chills
6%
Flank Pain
6%
Insomnia
3%
Urinary Frequency
3%
Vaginal Infection
3%
MRSA positive infection in toe
3%
Hemorrhoids
3%
Rash maculo-papular
3%
Diarrhea
3%
Depression
3%
Fibrinogen decreased
3%
Gastritis
3%
Hypomagnesemia
3%
Hypotension
3%
Non-cardiac chest pain
3%
Pain in extremity
3%
Palpitations
3%
Pruritus
3%
Sore Throat
3%
Wheezing
3%
Blurred Vision
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Allergic rhinitis
3%
Anorexia
3%
Lung Infection
3%
Arthralgia
3%
Dermatitis
3%
Creatinine increased
3%
Esophageal Spasms
3%
Hyperglycemia
3%
Lip Infection
3%
Muscle weakness upper limb
100%
80%
60%
40%
20%
0%
Study treatment Arm
Saline
Mesna

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
~7940

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.

Find a Location

Who is running the clinical trial?

TheradexIndustry Sponsor
33 Previous Clinical Trials
1,572 Total Patients Enrolled
Helix BioPharma CorporationLead Sponsor
3 Previous Clinical Trials
99 Total Patients Enrolled
Erkut Borazanci, MDPrincipal InvestigatorScottsdale Healthcare Hospitals DBA HonorHealth
7 Previous Clinical Trials
383 Total Patients Enrolled
~1 spots leftby Aug 2024
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