Phase 2 N=13 Treatment

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

Neoplasms · Neoplasm Metastasis · Triple Negative Breast Neoplasms · Head and Neck Neoplasms · Breast Neoplasms

Bottom Line

View on ClinicalTrials.gov: NCT03092934 ↗

Enrolled (actual)

Serious AEs

53.8%

Results posted

Jul 2021

Primary outcome: Primary: Phase 1: Maximum Tolerated Dose — 25 milligram (mg)

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: LY3295668 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Apr 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Phase 1: Maximum Tolerated Dose	25	—
PRIMARY Phase 2: Percentage of Participants Who Achieved Partial Response (PR) or Complete Response (CR) [Objective Response Rate (ORR)]	—	—
SECONDARY Phase 1: Number of Participants With One or More Treatment-Emergent Adverse Events	7; 2; 2	—
SECONDARY Phase 2: Number of Participants With One or More Treatment-Emergent Adverse Events	1	—
SECONDARY Phase 2: Pharmacokinetic (PK): Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post-dose (AUC[0-12]) (Phase 2)	—	—
SECONDARY Phase 2: PK: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Post-dose (AUC[0-24])	—	—
SECONDARY Phase 2: PK: Maximum Observed Plasma Concentration (Cmax)	NA; NA	—
SECONDARY Phase 2: PK: Time of Maximum Observed Plasma Concentration (Tmax)	NA; NA	—
SECONDARY Phase 2: PK: Apparent Terminal Elimination Half-life (t1/2)	—	—
SECONDARY Phase 2: PK: Apparent Total Plasma Clearance (CL/F)	—	—
SECONDARY Phase 2: PK: Apparent Volume of Distribution (Vz/F)	—	—
SECONDARY Phase 1: Number of Participants With Worst Post-Baseline Grade >=3 White Blood Cell Count (WBC)	1; 0; 0	—
SECONDARY Phase 1: Number of Participants With Worst Post-Baseline Grade >=3 Neutrophils (Segmented and Blended)	1; 0; 1	—
SECONDARY Phase 1: Number of Participants With Worst Post-Baseline Grade >=3 Lymphocytes	2; 1; 0	—

Summary

This two-part study consists of a phase 1 dose escalation study in participants with locally advanced or metastatic solid tumors, and a phase 2 portion in up to 3 groups with either small cell lung cancer, breast cancer and/or one other solid tumor type.

Eligibility Criteria

Inclusion Criteria

Have received at least 1 but no more than 4 prior systemic therapies
Have adequate organ function
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
Have estimated life expectancy greater than or equal to (≥)12 weeks
Have fully recovered from radiation therapy or surgery, and are recovering from any acute adverse effects of other cancer therapies
Have discontinued all chemotherapy, investigational therapy, molecularly-targeted therapy, and cancer-related hormonal therapy at least 14 days prior, biologic or immunotherapeutic therapy at least 21 days prior, or mitomycin-C or nitrosoureas at least 6 weeks prior
Female participants with reproductive potential agree to use 2 forms of highly effective contraception during the study and for the following 3 months
Male participants must use a barrier method of contraception during the study and for the following 3 months

Phase 1

Have evidence of a solid tumor that is locally advanced and/or metastatic (excluding primary brain tumor)

Phase 2

Have disease measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
Have evidence of a solid tumor that is locally advanced and/or metastatic, and in:
Small Cell Lung Cancer (SCLC), must have failed platinum-containing therapy
Breast Cancer, be Estrogen Receptor positive and/or Progesterone Receptor positive, but Human Epidermal Growth Factor Receptor 2 (HER2) negative, and must have failed a hormone therapy and a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor
Triple negative breast cancer (TNBC) and failed standard therapy
Squamous cell cancers of the head neck associated with the human papilloma virus (HPV), and have failed standard therapy
Other solid tumor type that has been approved by the sponsor

Exclusion Criteria

Have symptomatic central nervous system (CNS) metastasis (unless asymptomatic and not current receiving corticosteroids) or a primary tumor of the CNS
Have a medical condition that precludes participation (swallowing disorder, organ transplant, pregnant or nursing, HIV, active Hepatitis B or C, cardiac disease, history of major surgery in upper gastrointestinal (GI) tract or GI disease, hypokalemia, hypomagnesaemia or hypocalcaemia that cannot be controlled)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03092934). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.