Status:
TERMINATED
Phase 1 Study of LOP628 in Adult Patients With cKit-positive Solid Tumors and Acute Myeloid Leukemia
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
cKIT-positive Solid Tumors
AML
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT02221505
Start Date
December 1 2014
End Date
March 1 2015
Last Update
April 5 2016
Active Locations (4)
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1
Novartis Investigative Site
Parkville, Victoria, Australia, 3050
2
Novartis Investigative Site
Leuven, Belgium, 3000
3
Novartis Investigative Site
Leiden, Netherlands, 2300 RC
4
Novartis Investigative Site
Barcelona, Catalonia, Spain, 08035