Phase 1 Study of LOP628 in Adult Patients With cKit-positive Solid Tumors and Acute Myeloid Leukemia
- Registration Number
- NCT02221505
- Lead Sponsor
- Novartis Pharmaceuticals
- 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 cKit overexpressing tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LOP628 - Solid Tumor LOP628 with LOP628 LOP628 - AML LOP628 With LOP628 LOP628 - Solid Tumor Expansion LOP628 With LOP628
- Primary Outcome Measures
Name Time Method Incident rate of dose limiting toxicities (DLTs) Month 12 To estimate the maximum tolerated dose/recommended dose for expansion (MTD/RDE)
- Secondary Outcome Measures
Name Time Method Best overall response (BOR) 30 months To assess the preliminary anti-tumor activity of LOP628 in patients
Best Overall Response (AML) 30 months To assess the preliminary anti-tumor activity of LOP628
Duration of response (DOR) (AML) 30 months To assess the preliminary anti-tumor activity of LOP628
Event Free Survival (EFS) (AML) 30 months To assess the preliminary anti-tumor activity of LOP628
Incidence of adverse events (AEs) and serious adverse events (SAE) 30 months Characterize the safety and tolerability of LOP628
Severity of adverse events (AEs) and serious adverse events (SAEs) 30 months Characterize the safety and tolerability of LOP628
Serum PK parameters (AUC, Cmax, Tmax, and half-life) 30 months To characterize the pharmacokinetic profile of LOP628
Serum concentration vs. time profiles 30 months To characterize the pharmacokinetic profile of LOP628.
Overall response rate (ORR) 30 months To assess the preliminary anti-tumor activity of LOP628
Duration of response (DOR) 30 months To assess the preliminary anti-tumor activity of LOP628
Progression Free Survival (PFS) 30 months To assess the preliminary anti-tumor activity of LOP628
Disease Control Rate (DCR) at 4 months 4 months To assess the preliminary anti-tumor activity of LOP628
Trial Locations
- Locations (1)
Novartis Investigative Site
🇪🇸Barcelona, Catalunya, Spain