Trial Outcomes & Findings for A Study of AK-01 (LY3295668) in Solid Tumors (NCT NCT03092934)

Phase I participants are said to have completed the study if they completed Dose Limiting Toxicity (DLT) period or have had a DLT. Phase II participants who died or are alive and on study at conclusion but off treatment are defined as completed.

A Study of AK-01 (LY3295668) in Solid Tumors

Maximum Tolerated Dose (MTD) was defined as the dose immediately below the dose at which ≥2/3, ≥2/6, or ≥3/9 participants in a cohort experienced a dose limiting toxicity (DLT) during the first 21 days of treatment (Cycle 1) in Phase 1.

Objective response rate (ORR) was defined as a percentage of responders who achieved complete response or partial response (CR+PR) as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1). Complete response (CR) is defined as disappearance of all target (and non-target) lesions, and no appearance of new lesion. Partial response (PR) was defined as at least a 30% decrease in the sum of longest diameters (LD) of target lesions, taking as reference the baseline sum of LD, no progression of non-target lesions, and no appearance of new lesions.

A treatment-emergent adverse event (AE) is an AE that started or worsened (increased in severity) from the treatment start date to 30 days after the treatment end date. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.

A treatment-emergent adverse event (AE) is an AE that started or worsened (increased in severity) from the treatment start date to 30 days after the treatment end date. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.

Area under the plasma concentration-time curve for LY3295668 from time zero to 12 hours.

Area under the plasma concentration-time curve for LY3295668 from time zero to 24 hours.

Maximum observed plasma concentration for LY3295668.

Time of maximum observed plasma concentration of LY3295668.

Apparent terminal elimination half-life of LY3295668.

Apparent total plasma clearance of LY3295668.

Apparent volume of distribution of LY3295668.

Presented are participants with the worst post-baseline WBC Grade \>= 3 using the National Cancer Institute (NCI) Common Terminology Criteria For Adverse Events version 4.03 (CTCAE v4.03). where Grade 1: \< Lower Limit Normal (LLN) - 3000/mm3; \<LLN - 3.0 x10e9/L, Grade 2: \<3000 - 2000/mm3; \<3.0 - 2.0 x10e9/L, Grade 3: \<2000 - 1000/mm3; \<2.0 1.0 x10e9/L, Grade 4: \<1000/mm3; \<1.0 x10e9/L.

Presented are participants with the worst post-baseline neutrophils Grade \>=3 using the NCI-CTCAE v4.03 where Grade 1: \< LLN - 1500/mm3; \<LLN - 1.5 x10e9/L, Grade 2: \<1500 - 1000/mm3; \<1.5 - 1.0 x10e9/L, Grade 3: \<1000 - 500/mm3; \<1.0 - 0.5 x10e9/L, Grade 4: \<500/mm3; \<0.5 x 10e9/L.

Presented are participants with the worst post-baseline lymphocytes Grade \>=3 using the NCI-CTCAE version 4.03 where Grade 1: \<LLN - \<800/mm3, \<LLN - 0.8 x 10e9/L, Grade 2: \<800 - 500/mm3; \<0.8 - 0.5 x 10e9/L, Grade 3: \<500 - 200/mm3; \<0.5 - 0.2 x 10e9/L, \<200mm3; \<0.2 x 10e9/L.