Non-Small Cell Lung CancerPhase 1/2NCT02340208
A Phase I/II Open-Label, Non-Randomized Dose Escalation Study of Immunoconjugate L-DOS47
A Phase 1/2 study testing L-DOS47 in people with Non-Small Cell Lung Cancer, run by Helix BioPharma Corporation at 5 sites in Poland.
Trial summary
The primary purpose of this research study is to evaluate how safe, how well tolerated and how effective a range of doses of L-DOS47 in patients with non-squamous non-small cell lung cancer when given as a monotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- L-DOS47
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 5 sitesPoland
- Study dates
- May 2012to 20 Dec 2017
- 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
Main Inclusion Criteria:
Patients will be entered in the study only if they meet all of the following criteria:
- Male or female aged ≥ 18 years old
- Have histologically confirmed non-squamous NSCLC that are:
- Chemo naïve Stage IIIb or IV non-squamous NSCLC who are not candidates for chemotherapy or radiotherapy, or who refused standard therapy
- Refractory Stage IIIb or IV non-squamous NSCLC. (Staging of non-squamous NSCLC must be assessed according to TNM, 7th edition and based on computed tomography (CT) scan.)
- Have at least a single measurable lesion in accordance with the RECIST v1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status: 0-2
- Have a life expectancy of ≥ 3 months
- Have adequate bone marrow, renal and liver function
Main Exclusion Criteria:
- Are pregnant or nursing mother
- Have a prior history of other malignancies with the exception of non melanoma skin cancer
- Have known history of central nervous system (CNS) metastatic disease (previously treated or untreated)
- Show evidence of active infection
- Have received treatment in another clinical study within the 30 days before commencing study drug or have not recovered from side effects of a study drug, except for alopecia
- Have a serious uncontrolled medical condition
- Known positive human immunodeficiency virus (HIV), known hepatitis B surface antigen, or hepatitis C positive
- Sustained QTc (QT interval corrected for heart rate) with Fridericia's correction > 450 ms at screening, or a history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome)
- Pre-existing peripheral neuropathy ≥ CTC Grade 2
- Have dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent or compliance with the requirements of the protocol
- Are receiving chemotherapy during the 30 days before study treatment start; are receiving radiotherapy, targeted therapy, hormonal therapy, immunotherapy, major surgery or other study drugs during the 4 weeks before study treatment start, or have not recovered from all treatment related toxicities to Grade ≤ 1, except for alopecia. (Radiotherapy is allowed for the symptomatic treatment of bone metastases.)
- Are taking systemic steroids (other than inhalers or topical steroids) or other medication to suppress the immune system
- Are participating (or planning to participate) in any other clinical trial during this study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Poland5 sites
Mazovian Center of Pulmonary Diseases and Tuberculosis
Otwock
Med. Polonia Hospital Poznan
Poznan
Institute of Tuberculosis and Lung Diseases
Warsaw
Military Medical Institute
Warsaw
The Maria Sklodowska-Curie Memorial Cancer Centre & Institute of Oncology
Warsaw
About this study
Official title: A Phase I/II Open-Label, Non-Randomized Dose Escalation Study of Immunoconjugate L-DOS47 as a Monotherapy in Non-Squamous Non-Small Cell Lung Cancer Patients
The primary purpose of this research study is to evaluate how safe, how well tolerated and how effective a range of doses of L-DOS47 in patients with non-squamous non-small cell lung cancer when given as a monotherapy.
Read the detailed description
Patients will be recruited into cohorts, with a minimum of three and a maximum of six patients per cohort. All patients at a given dose level must complete Cycle 1 (3 week period) before escalation in subsequent patients can proceed. The decision for dose escalation to the next dose level will be made after the safety and available pharmacokinetic (PK) data have been reviewed by the Trial Steering Committee (TSC).
Escalation of L-DOS47 will continue until a maximum tolerated dose (MTD) is reached.
After the MTD of L-DOS47 has been determined in Phase I, up to 20 patients will be enrolled (taken forward from Phase I) to evaluate the preliminary efficacy of L-DOS47 (i.e., response rate using the Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1 criteria, disease progression and survival); monitoring will include radiologic evaluations every second cycle. The safety and tolerability of L-DOS47 will also be further evaluated. Pharmacokinetic information will be collected as well as relevant observations on the activity of L-DOS47.
For all patients, treatment with L-DOS47 will continue either until the patient experiences disease progression, unacceptable toxicity, the patient withdraws consent or has completed four treatment cycles and does not wish to continue with additional cycles, whichever occurs first. After four cycles, patients may continue to receive L-DOS47 for as long as there is sustained clinical benefit and it is well tolerated, in the opinion of the Investigator.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- L-DOS47
- Keywords
- Non-Small Cell Lung Cancer, Neoplasms, Immunoconjugate, Tumor microenvironment alkalinization
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-DOS47Drug
A treatment cycle will be 21 days with patients receiving L-DOS47 on cycle Days 1 and 8.
| Study group | Role | What they receive |
|---|---|---|
| L-DOS47 | Experimental | Patient will be recruited into cohorts of L-DOS47 escalating doses, with a minimum of 3 and a maximum of 6 patients per cohort. The starting dose of L-DOS47 will be 0.12 μg/kg; further possible dose levels include 0.21, 0.33, 0.46, 0.59, 0.78, 1.04, 1.38, 1.84, 2.45, 3.26 and 4.33 μg/kg. Receives: Drug: L-DOS47 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of drug-related adverse events as a measure of safety and tolerability of L-DOS47
Assessed during the AE reporting period starts on Cycle 1 Day 1 up to the last study visit.
Measured: Up to 12 weeks
Secondary outcomes (4)
L-DOS47 related toxicity during the first 2 hours after infusion
Assessed by the incidence and severity of AEs and SAEs and changes in vital signs
Measured: During the first 2 hours after infusion
The incidence and severity of all reported adverse events and serious adverse events
Assessed during the AE reporting period starts on Cycle 1 Day 1 up to the last study visit.
Measured: Participants will be followed for 12 weeks and the 30 day follow-up period
Changes from baseline for additional safety parameters (clinical laboratory assessments, vital signs, weight, oxygen requirement and 12-lead ECG)
Safety parameters include clinical laboratory assessments, vital signs, weight, oxygen requirement and 12-lead ECG
Measured: Up to 12 weeks
The evaluation of anti-L-DOS47 antibody over time
Serum samples will be collected and analyzed from all patients dosed with L-DOS47.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study startMay 2012
- Primary completion1 Aug 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung 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
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helix BioPharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharm-Olam International
- Responsible party
- Sponsor
- Investigators
- Dariusz Kowalski, MD, PhD, Principal investigator, The Maria Sklodowska-Curie Memorial Cancer Centre & Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340208
- Sponsor's protocol ID
- LDOS002
- Status last verified
- Mar 2019
- First submitted
- 13 Jan 2015
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Open-Label, Non-Randomized Dose Escalation Study of Immunoconjugate L-DOS47 as a Monotherapy in Non-Squamous Non-Small Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT02340208
- Acronym / sponsor ID
- LDOS002
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, Neoplasms, Immunoconjugate, Tumor microenvironment alkalinization
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Helix BioPharma CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Pharm-Olam International
- Study start
- May 2012
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 16 Jan 2015 (estimated)
- 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.
The primary purpose of this research study is to evaluate how safe, how well tolerated and how effective a range of doses of L-DOS47 in patients with non-squamous non-small cell lung cancer when given as a monotherapy.
Detailed description
Patients will be recruited into cohorts, with a minimum of three and a maximum of six patients per cohort. All patients at a given dose level must complete Cycle 1 (3 week period) before escalation in subsequent patients can proceed. The decision for dose escalation to the next dose level will be made after the safety and available pharmacokinetic (PK) data have been reviewed by the Trial Steering Committee (TSC).
Escalation of L-DOS47 will continue until a maximum tolerated dose (MTD) is reached.
After the MTD of L-DOS47 has been determined in Phase I, up to 20 patients will be enrolled (taken forward from Phase I) to evaluate the preliminary efficacy of L-DOS47 (i.e., response rate using the Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1 criteria, disease progression and survival); monitoring will include radiologic evaluations every second cycle. The safety and tolerability of L-DOS47 will also be further evaluated. Pharmacokinetic information will be collected as well as relevant observations on the activity of L-DOS47.
For all patients, treatment with L-DOS47 will continue either until the patient experiences disease progression, unacceptable toxicity, the patient withdraws consent or has completed four treatment cycles and does not wish to continue with additional cycles, whichever occurs first. After four cycles, patients may continue to receive L-DOS47 for as long as there is sustained clinical benefit and it is well tolerated, in the opinion of the Investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| L-DOS47 | Experimental | Drug: L-DOS47Patient will be recruited into cohorts of L-DOS47 escalating doses, with a minimum of 3 and a maximum of 6 patients per cohort. The starting dose of L-DOS47 will be 0.12 μg/kg; further possible dose levels include 0.21, 0.33, 0.46, 0.59, 0.78, 1.04, 1.38, 1.84, 2.45, 3.26 and 4.33 μg/kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 21 days with patients receiving L-DOS47 on cycle Days 1 and 8. | Drug | L-DOS47 |
Primary outcome
The incidence and severity of drug-related adverse events as a measure of safety and tolerability of L-DOS47
Time frame: Up to 12 weeks
Assessed during the AE reporting period starts on Cycle 1 Day 1 up to the last study visit.
4 secondary outcomes
L-DOS47 related toxicity during the first 2 hours after infusion
Time frame: During the first 2 hours after infusion
The incidence and severity of all reported adverse events and serious adverse events
Time frame: Participants will be followed for 12 weeks and the 30 day follow-up period
Changes from baseline for additional safety parameters (clinical laboratory assessments, vital signs, weight, oxygen requirement and 12-lead ECG)
Time frame: Up to 12 weeks
The evaluation of anti-L-DOS47 antibody over time
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
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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.
Dariusz Kowalski, MD, PhD principal investigator
The Maria Sklodowska-Curie Memorial Cancer Centre & Institute of Oncology
5 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 in people with Non-Small Cell Lung Cancer, run by Helix BioPharma Corporation at 5 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Poland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The incidence and severity of drug-related adverse events as a measure of safety and tolerability of L-DOS47 (time frame: Up to 12 weeks). 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 14 Mar 2019.