Phase 1 Study of LOP628 in Adult Patients With cKit-positive Solid Tumors and Acute Myeloid Leukemia

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

- 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 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

- Patient has been previously treated with cKit directed antibodies

- Pregnant or nursing women