Pancreas CancerPhase 1/2NCT04203641
L-DOS47 Plus Doxorubicin in Advanced Pancreatic Cancer
A Phase 1/2 study testing L-DOS47 and Doxorubicin in people with Pancreas Cancer, run by Helix BioPharma Corporation at 3 sites in United States.
Trial summary
This study will evaluate the safety and tolerability of escalating doses of L-DOS47 in combination with doxorubicin, as well as preliminary anti-tumor activity in patients with previously treated advanced pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- L-DOS47 and Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Dec 2019to 24 Oct 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥ 18 years old
- 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.
- Karnofsky performance status ≥ 70%
- Life expectancy of at least 3 months
- Able to understand the information provided to them and to give written institutional review board (IRB)-approved informed consent prior to any study activities being conducted
- A negative pregnancy test (if of child bearing potential)
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- Acceptable liver function:
- Bilirubin ≤ 1.5 times upper limit of normal
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and Alkaline phosphatase (ALP) ≤ 2.5 times upper limit of normal (ULN; if liver metastases are present, then ≤ 5 x ULN is allowed)
- 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
- Acceptable hematologic status:
- Granulocyte ≥ 1500 cells/mm3
- Platelet count ≥ 100,000 (plt/mm3)
- Hemoglobin ≥ 9g/dL
- Urinalysis:
- No clinically significant abnormalities
- Acceptable coagulation status
- Prothrombin time within 1.5x of normal limits
- Partial thromboplastin time (PTT) within 1.5x of normal limits
- For men and women of child-bearing potential, the use of effective contraceptive methods during the study
- Normal ejection fraction on ECHO or MUGA
Who cannot join
- New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG
- Abnormal ejection fraction on ECHO or MUGA
- Active, uncontrolled bacterial, viral, or fungal infections requiring systematic therapy
- Pregnant or nursing women. NOTE: Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant while participating in this study, she should inform her treating physician immediately.
- Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within 3 weeks prior to study entry
- Major surgery within 4 weeks prior to study entry
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- Unwillingness or inability to comply with procedures required in this protocol
- Known infection with HIV, hepatitis B, or hepatitis C
- Serious nonmalignant disease (eg hydro nephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
- Patients who are currently receiving any other investigational agent
- Patients with any evidence of uncontrolled brain metastases or carcinomatosis meningitis.
- Patients with marked screening prolongation of QT/QTc interval (e.g. repeated demonstration of a QTc interval > 480 milliseconds (CTCAE grade 1) using Fredericia's QT correction formula.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Atlantic Health System, Morristown Medical Center
Morristown, New Jersey, 07962
Scottsdale Healthcare Hospitals DBA HonorHealth
Scottsdale, Arizona, 85260
About this study
Official title: A Phase Ib/II Study of the Microenvironment Modifier L-DOS47 Plus Doxorubicin for the Treatment of Patients With Previously Treated Advanced Pancreatic Cancer
This study will evaluate the safety and tolerability of escalating doses of L-DOS47 in combination with doxorubicin, as well as preliminary anti-tumor activity in patients with previously treated advanced pancreatic cancer.
Read the detailed description
The Phase Ib part of the study will apply a standard 3 + 3 algorithm for dose escalation to determine the appropriate L-DOS47 maximum tolerated dose to use in combination with doxorubicin for the Phase II part of the study. Patients will be recruited into 3 cohorts where each cohort will receive increasing weekly dose levels of L-DOS47 in combination with a fixed dose of 20 mg/m2 of doxorubicin weekly. The decision for escalation to the next dose level will be made after all patients in a cohort have completed 4 weeks of combination treatment and the safety data have been reviewed by the Safety Review Committee. If a patient in any cohort experiences a dose limiting toxicity, an additional 3 patients will be enrolled, for a maximum of up to 18 patients in this initial dose escalation part of the study.
The Phase II part of the study will focus on evaluating preliminary anti-tumor activity, as well as continuing to evaluate safety and tolerability of L-DOS47 in combination with doxorubicin. A further 11 additional patients will be enrolled in this phase of the study, which is designed to ensure patient safety and to detect whether there is a level of anti-tumor activity that would be worth pursuing in a larger clinical trial. Patients will be initiated on the L-DOS47 dose determined in Phase I, in combination with 20 mg/m2 doxorubicin, with tumor marker carbohydrate antigen 19-9 (CA19-9) measurements at each treatment cycle, and radiological assessments every two treatment cycles.
Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
Safety will be assessed by reported adverse events (AEs), serious adverse events (SAEs), physical exams, vital signs, Karnofsky Performance Status, electrocardiogram (ECG), echocardiogram (ECHO)/multigated acquisition scan (MUGA), clinical laboratory evaluations (hematology, chemistry, coagulation and urinalysis), and anti-L-DOS47 antibody levels.
- Conditions
- Pancreas Cancer
- Being tested
- L-DOS47, Doxorubicin
- Keywords
- pancreatic cancer, immunoconjugate, tumor microenvironment alkalinization
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-DOS47Biological
A treatment cycle will be 28 days, with patients receiving L-DOS47 on Days 1, 8, 15, and 22.
DoxorubicinDrug
A treatment cycle will be 28 days, with patients receiving doxorubicin on Days 2, 9, 16 and 23
| Study group | Role | What they receive |
|---|---|---|
| L-DOS47 + doxorubicin | Experimental | 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. Receives: Biological: L-DOS47; Drug: Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of complete plus partial responders as per RECIST version 1.1
Assess number of complete plus partial responders according to RECIST version 1.1 as a measure of preliminary anti-tumor activity of L-DOS47 in combination with doxorubicin
Measured: 24 weeks
Adverse events (as per CTCAE v. 5.0)
Assess frequency of treatment emergent adverse events as per Common Terminology Criteria for Adverse Events (CTCAE) v. 5 as a measure of safety and tolerability of L-DOS47 in combination with doxorubicin
Measured: 24 weeks
Secondary outcomes (3)
Change in tumor pH
Change from screening tumor pH as measured by SUV on fluorodeoxyglucose-positron emission tomography scan (FDG-PET) scan
Measured: From screening to end of Cycle 2, where each treatment cycle is 28 days.
Carbohydrate antigen (CA) 19-9 biomarker level
Change from screening in CA19-9 biomarker levels
Measured: Up to 24 weeks
Proportion of patients expressing anti-L-DOS47 antibodies
Assess number of patients expressing anti-L-DOS47 antibodies levels as a measure of
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start11 Dec 2019
- Primary completion24 Oct 2024
- Study completion24 Oct 2024
Why it stopped: The primary reason for early termination was budget constraint.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- This is an open-label, single arm study that includes an initial three cohort dose escalation phase with 3, 6 and 9 µg/kg of L-DOS47 in combination with doxorubicin.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helix BioPharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Theradex
- Responsible party
- Sponsor
- Investigators
- Erkut Borazanci, MD, Principal investigator, Scottsdale Healthcare Hospitals DBA HonorHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203641
- Sponsor's protocol ID
- LDOS006
- Status last verified
- Oct 2024
- First submitted
- 16 Sep 2019
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Study of the Microenvironment Modifier L-DOS47 Plus Doxorubicin for the Treatment of Patients With Previously Treated Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04203641
- Acronym / sponsor ID
- LDOS006
- Conditions
- Pancreas Cancer
- Keywords
- pancreatic cancer, immunoconjugate, tumor microenvironment alkalinization
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The primary reason for early termination was budget constraint.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Helix BioPharma CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Theradex
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 24 Oct 2024 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and tolerability of escalating doses of L-DOS47 in combination with doxorubicin, as well as preliminary anti-tumor activity in patients with previously treated advanced pancreatic cancer.
Detailed description
The Phase Ib part of the study will apply a standard 3 + 3 algorithm for dose escalation to determine the appropriate L-DOS47 maximum tolerated dose to use in combination with doxorubicin for the Phase II part of the study. Patients will be recruited into 3 cohorts where each cohort will receive increasing weekly dose levels of L-DOS47 in combination with a fixed dose of 20 mg/m2 of doxorubicin weekly. The decision for escalation to the next dose level will be made after all patients in a cohort have completed 4 weeks of combination treatment and the safety data have been reviewed by the Safety Review Committee. If a patient in any cohort experiences a dose limiting toxicity, an additional 3 patients will be enrolled, for a maximum of up to 18 patients in this initial dose escalation part of the study.
The Phase II part of the study will focus on evaluating preliminary anti-tumor activity, as well as continuing to evaluate safety and tolerability of L-DOS47 in combination with doxorubicin. A further 11 additional patients will be enrolled in this phase of the study, which is designed to ensure patient safety and to detect whether there is a level of anti-tumor activity that would be worth pursuing in a larger clinical trial. Patients will be initiated on the L-DOS47 dose determined in Phase I, in combination with 20 mg/m2 doxorubicin, with tumor marker carbohydrate antigen 19-9 (CA19-9) measurements at each treatment cycle, and radiological assessments every two treatment cycles.
Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
Safety will be assessed by reported adverse events (AEs), serious adverse events (SAEs), physical exams, vital signs, Karnofsky Performance Status, electrocardiogram (ECG), echocardiogram (ECHO)/multigated acquisition scan (MUGA), clinical laboratory evaluations (hematology, chemistry, coagulation and urinalysis), and anti-L-DOS47 antibody levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label, single arm study that includes an initial three cohort dose escalation phase with 3, 6 and 9 µg/kg of L-DOS47 in combination with doxorubicin.
| Arm | Type | Receives |
|---|---|---|
| L-DOS47 + doxorubicin | Experimental | Biological: L-DOS47, Drug: DoxorubicinPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Male or female aged ≥ 18 years old
- 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.
- Karnofsky performance status ≥ 70%
- Life expectancy of at least 3 months
- Able to understand the information provided to them and to give written institutional review board (IRB)-approved informed consent prior to any study activities being conducted
Key exclusion criteria (12 listed)
- New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG
- Abnormal ejection fraction on ECHO or MUGA
- Active, uncontrolled bacterial, viral, or fungal infections requiring systematic therapy
- Pregnant or nursing women. NOTE: Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant while participating in this study, she should inform her treating physician immediately.
- Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within 3 weeks prior to study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-DOS47A treatment cycle will be 28 days, with patients receiving L-DOS47 on Days 1, 8, 15, and 22. | Biological | L-DOS47 + doxorubicin |
| DoxorubicinA treatment cycle will be 28 days, with patients receiving doxorubicin on Days 2, 9, 16 and 23 | Drug | L-DOS47 + doxorubicin |
Primary outcome
Number of complete plus partial responders as per RECIST version 1.1
Time frame: 24 weeks
Assess number of complete plus partial responders according to RECIST version 1.1 as a measure of preliminary anti-tumor activity of L-DOS47 in combination with doxorubicin
Adverse events (as per CTCAE v. 5.0)
Time frame: 24 weeks
Assess frequency of treatment emergent adverse events as per Common Terminology Criteria for Adverse Events (CTCAE) v. 5 as a measure of safety and tolerability of L-DOS47 in combination with doxorubicin
3 secondary outcomes
Change in tumor pH
Time frame: From screening to end of Cycle 2, where each treatment cycle is 28 days.
Carbohydrate antigen (CA) 19-9 biomarker level
Time frame: Up to 24 weeks
Proportion of patients expressing anti-L-DOS47 antibodies
Time frame: Up to 24 weeks
Results and safety
The study was stopped early (reason given: The primary reason for early termination was budget constraint.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erkut Borazanci, MD principal investigator
Scottsdale Healthcare Hospitals DBA HonorHealth
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing L-DOS47 and Doxorubicin in people with Pancreas Cancer, run by Helix BioPharma Corporation at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The primary reason for early termination was budget constraint.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of complete plus partial responders as per RECIST version 1.1 (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.