cKIT-positive Solid TumorsPhase 1NCT02221505
Phase 1 Study of LOP628 in Adult Patients With cKit-positive Solid Tumors and Acute Myeloid Leukemia
A Phase 1 study testing LOP628 in people with cKIT-positive Solid Tumors and AML, run by Novartis Pharmaceuticals at 4 sites in 4 countries.
Trial summary
LOP628 is an antibody-drug conjugate (ADC) consisting of an anti-cKit humanized IgG1/κ antibody conjugated to a maytansine payload via a non-cleavable linker. LOP628 provides an opportunity to target cKit overexpressing tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- cKIT-positive Solid Tumors, AML
- What is being tested?
- LOP628
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Dec 2014to Mar 2015
- Phase
- Phase 1
- 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
- For patients with solid tumors:
- documented cKit-positive neoplasms
- Patient must have progressive disease as defined by any of the following:
- SCLC: patient has progressed after at least 1 prior therapy
- GIST : patient has relapsed or has refractory disease, and no further approved effective therapeutic option exists
- Patients with other cKit-positive solid tumors: patient has progressed after at least one prior line of therapy and no further approved effective therapeutic option exists
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- Patient has measurable disease as per RECIST v1.1 criteria
- For patients with AML:
- documented cKit-positive acute myelogenous leukemia
- Consent to newly obtained bone marrow aspirate
- Patient must have progressive disease defined as relapsed or refractory non-PML AML following standard therapy or for whom no effective therapy exists.
- Blast count < 50,000/mm3
Who cannot join
- For patients with solid tumors:
- Patient has central nervous system (CNS) metastatic involvement unless the CNS metastases have been previously treated and the patient is clinically stable and on a stable dose of corticosteroids for at least 4 weeks prior to enrollment.
- Patient has the presence of other clinically significant hematologic, cardiac, respiratory, gastrointestinal, renal, hepatic or neurological conditions.
- Patient has a history of serious allergic reactions, which in the opinion of the investigator may pose an increased risk of serious infusion reactions
- Patient has been previously treated with cKit directed antibodies
- Pregnant or nursing women
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- For patients with AML:
- Patient has received prior allogeneic bone marrow transplant (BMT).
- Patient has the presence of other clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological disease
- Patient has a history of serious allergic reactions, which in the opinion of the investigator may pose an increased risk of serious infusion reactions
- Patient has been previously treated with cKit directed antibodies
- Pregnant or nursing women
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: A Phase I, Multicenter, Open-label Dose Escalation and Expansion Study of LOP628, Administered Intravenously in Adult Patients With cKit-positive Tumors and Acute Myeloid Leukemia
LOP628 is an antibody-drug conjugate (ADC) consisting of an anti-cKit humanized IgG1/κ antibody conjugated to a maytansine payload via a non-cleavable linker.
LOP628 provides an opportunity to target cKit overexpressing tumors.
- Conditions
- cKIT-positive Solid Tumors, AML
- Being tested
- LOP628
- Keywords
- LOP628,, cKit,, ADC,, Antibody drug conjugates,, maytansine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOP628Drug
| Study group | Role | What they receive |
|---|---|---|
| LOP628 - Solid Tumor | Experimental | with LOP628 Receives: Drug: LOP628 |
| LOP628 - AML | Experimental | With LOP628 Receives: Drug: LOP628 |
| LOP628 - Solid Tumor Expansion | Experimental | With LOP628 Receives: Drug: LOP628 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident rate of dose limiting toxicities (DLTs)
To estimate the maximum tolerated dose/recommended dose for expansion (MTD/RDE)
Measured: Month 12
Secondary outcomes (12)
Incidence of adverse events (AEs) and serious adverse events (SAE)
Characterize the safety and tolerability of LOP628
Measured: 30 months
Severity of adverse events (AEs) and serious adverse events (SAEs)
Characterize the safety and tolerability of LOP628
Measured: 30 months
Serum PK parameters (AUC, Cmax, Tmax, and half-life)
To characterize the pharmacokinetic profile of LOP628
Measured: 30 months
Serum concentration vs. time profiles
To characterize the pharmacokinetic profile of LOP628.
Measured: 30 months
Overall response rate (ORR)
To assess the preliminary anti-tumor activity of LOP628
Measured: 30 months
Duration of response (DOR)
To assess the preliminary anti-tumor activity of LOP628
Measured: 30 months
Progression Free Survival (PFS)
To assess the preliminary anti-tumor activity of LOP628
Measured: 30 months
Disease Control Rate (DCR) at 4 months
To assess the preliminary anti-tumor activity of LOP628
Measured: 4 months
Best overall response (BOR)
To assess the preliminary anti-tumor activity of LOP628 in patients
Measured: 30 months
Best Overall Response (AML)
To assess the preliminary anti-tumor activity of LOP628
Measured: 30 months
Duration of response (DOR) (AML)
To assess the preliminary anti-tumor activity of LOP628
Measured: 30 months
Event Free Survival (EFS) (AML)
To assess the preliminary anti-tumor activity of LOP628
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for cKIT-positive Solid TumorsStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221505
- Sponsor's protocol ID
- CLOP628X2101
- Status last verified
- Apr 2016
- First submitted
- 8 Aug 2014
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter, Open-label Dose Escalation and Expansion Study of LOP628, Administered Intravenously in Adult Patients With cKit-positive Tumors and Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT02221505
- Acronym / sponsor ID
- CLOP628X2101
- Conditions
- cKIT-positive Solid Tumors, AML
- Keywords
- LOP628,, cKit,, ADC,, Antibody drug conjugates,, maytansine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 20 Aug 2014 (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.
LOP628 is an antibody-drug conjugate (ADC) consisting of an anti-cKit humanized IgG1/κ antibody conjugated to a maytansine payload via a non-cleavable linker.
LOP628 provides an opportunity to target cKit overexpressing tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LOP628 - Solid Tumor | Experimental | Drug: LOP628with LOP628 |
| LOP628 - AML | Experimental | Drug: LOP628With LOP628 |
| LOP628 - Solid Tumor Expansion | Experimental | Drug: LOP628With LOP628 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- documented cKit-positive neoplasms
- Patient must have progressive disease as defined by any of the following:
- SCLC: patient has progressed after at least 1 prior therapy
- GIST : patient has relapsed or has refractory disease, and no further approved effective therapeutic option exists
- Patients with other cKit-positive solid tumors: patient has progressed after at least one prior line of therapy and no further approved effective therapeutic option exists
Key exclusion criteria (12 listed)
- Patient has central nervous system (CNS) metastatic involvement unless the CNS metastases have been previously treated and the patient is clinically stable and on a stable dose of corticosteroids for at least 4 weeks prior to enrollment.
- Patient has the presence of other clinically significant hematologic, cardiac, respiratory, gastrointestinal, renal, hepatic or neurological conditions.
- Patient has a history of serious allergic reactions, which in the opinion of the investigator may pose an increased risk of serious infusion reactions
- Patient has been previously treated with cKit directed antibodies
- Pregnant or nursing women
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 |
|---|---|---|
| LOP628 | Drug | LOP628 - AML, LOP628 - Solid Tumor, LOP628 - Solid Tumor Expansion |
Primary outcome
Incident rate of dose limiting toxicities (DLTs)
Time frame: Month 12
To estimate the maximum tolerated dose/recommended dose for expansion (MTD/RDE)
12 secondary outcomes
Incidence of adverse events (AEs) and serious adverse events (SAE)
Time frame: 30 months
Severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 30 months
Serum PK parameters (AUC, Cmax, Tmax, and half-life)
Time frame: 30 months
Serum concentration vs. time profiles
Time frame: 30 months
Overall response rate (ORR)
Time frame: 30 months
Duration of response (DOR)
Time frame: 30 months
Progression Free Survival (PFS)
Time frame: 30 months
Disease Control Rate (DCR) at 4 months
Time frame: 4 months
Best overall response (BOR)
Time frame: 30 months
Best Overall Response (AML)
Time frame: 30 months
Duration of response (DOR) (AML)
Time frame: 30 months
Event Free Survival (EFS) (AML)
Time frame: 30 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2016.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LOP628 in people with cKIT-positive Solid Tumors and AML, run by Novartis Pharmaceuticals at 4 sites in 4 countries.
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 12 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 5 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia, Belgium, Netherlands, Spain. 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 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.
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. 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?
Incident rate of dose limiting toxicities (DLTs) (time frame: Month 12). 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 5 Apr 2016.