A Study of LY3022855 in Combination With Durvalumab or Tremelimumab in Participants With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2018-12-14
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to evaluate the safety of the colony-stimulating factor 1 receptor (CSF-1R) inhibitor LY3022855 in combination with durvalumab or tremelimumab in participants with advanced solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: AstraZeneca
• Treatments: Antibodies, Monoclonal; Durvalumab; Tremelimumab

Criteria

Inclusion Criteria:

• Must have histological or cytological evidence of a diagnosis of cancer that is not amenable to curative therapy.

• Part B: Must have a type of malignancy that is being studied.

• Part A and Part B: Must be willing to undergo pretreatment and on-treatment core needle or excisional tumor biopsies.

• Part A (all cohorts): Have the presence of measureable and /or nonmeasurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

• Part B (all cohorts): Have the presence of measurable disease as defined by the RECIST 1.1.

• Have adequate normal organ and marrow function, including the following:

• Absolute neutrophil count ≥ 1.5 x 10⁹/Liters (L) (1500/cubic millimeters)

• Platelet count ≥ 100 x 10⁹/L (≥100,000/cubic millimeters)

• Hemoglobin ≥9 grams per deciliter or ≥5.6 millimoles per liter

• Serum Creatinine ≤1.5 × institutional upper limit of normal (ULN)

• Total bilirubin ≤1.5 × institutional ULN

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × institutional ULN OR ≤5 × institutional ULN for participants with liver metastases

• International normalized ratio (INR) or prothrombin time (PT) INR ≤1.5 × institutional ULN or PT ≤5 seconds above institutional ULN

• PTT or activated partial thromboplastin time (aPTT) ≤5 seconds above institutional ULN

• Thyroid stimulating hormone (TSH) OR free thyroxine (T4) within the normal limits

• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale.

Exclusion Criteria:

• Are currently receiving or have had prior use of immunosuppressive medication within 28 days before the first dose of study drug, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 milligrams/day of prednisone, or an equivalent corticosteroid.

• Have symptomatic central nervous system (CNS) malignancy or metastasis.

• Have had any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, have any unresolved irAE Grade >1, or any irAE that led to the permanent discontinuation of prior immunotherapy.

• Have experienced a Grade ≥3 AE or a neurologic or ocular AE of any grade while receiving prior immunotherapy.