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Clinical Trials/NCT02221505
NCT02221505
Terminated
Phase 1

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

Novartis Pharmaceuticals1 site in 1 country3 target enrollmentStarted: December 2014Last updated:
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ConditionscKIT-positive Solid TumorsAML
InterventionsLOP628
DrugsLOP628

Overview

Phase
Phase 1
Status
Terminated
Enrollment
3
Locations
1
Primary Endpoint
Incident rate of dose limiting toxicities (DLTs)
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Arms & Interventions

LOP628 - Solid Tumor

Experimental

with LOP628

Intervention: LOP628 (Drug)

LOP628 - AML

Experimental

With LOP628

Intervention: LOP628 (Drug)

LOP628 - Solid Tumor Expansion

Experimental

With LOP628

Intervention: LOP628 (Drug)

Outcomes

Primary Outcomes

Incident rate of dose limiting toxicities (DLTs)

Time Frame: Month 12

To estimate the maximum tolerated dose/recommended dose for expansion (MTD/RDE)

Secondary Outcomes

  • Best overall response (BOR)(30 months)
  • Best Overall Response (AML)(30 months)
  • Duration of response (DOR) (AML)(30 months)
  • Event Free Survival (EFS) (AML)(30 months)
  • Incidence of adverse events (AEs) and serious adverse events (SAE)(30 months)
  • Severity of adverse events (AEs) and serious adverse events (SAEs)(30 months)
  • Serum PK parameters (AUC, Cmax, Tmax, and half-life)(30 months)
  • Serum concentration vs. time profiles(30 months)
  • Overall response rate (ORR)(30 months)
  • Duration of response (DOR)(30 months)
  • Progression Free Survival (PFS)(30 months)
  • Disease Control Rate (DCR) at 4 months(4 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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