Clinical trial NCT04099277: A Study of LY3435151 in Participants With Solid Tumors
Official title: A Phase 1a/1b Study of LY3435151 Administered to Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Solid Tumor
Triple-negative Breast Cancer
Gastric Adenocarcinoma
Head and Neck Squamous Cell Carcinoma
Cervical Carcinoma
High Grade Serous Ovarian Carcinoma
Hepatocellular Carcinoma
Undifferentiated Pleomorphic Sarcoma
Leiomyosarcoma
Keywords: immunotherapy
CD226 agonist
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-09-23
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The reason for this study is to see if the study drug LY3435151 is safe in participants with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* Participant must have certain types of cancer, which your study doctor will discuss with you
* Participant must have stopped other forms of treatment for cancer, which your study doctor will discuss with you
* Participant must be able and willing to provide a sample of your tumor before beginning treatment and once while on treatment. For certain tumor types, the outcome of the biopsy may exclude you from the study treatment (for Phase 1b)
* Participant must agree to use birth control
* Participant must have progressed through or are intolerant to therapies with known clinical benefit, which your study doctor will discuss with you

Exclusion Criteria:

* Participant must not have a history of tuberculosis, uncontrolled HIV or uncontrolled hepatitis B or C virus infection
* Participant must not have an autoimmune disease, which your study doctor will discuss with you
* Participant must not use corticosteroids, which your study doctor will discuss with you
* Participant must not have heart disease, Crohn's disease or brain cancer
* Participant must not be pregnant or breastfeeding

Primary outcomes:
measure: Number of Participants With LY3435151 Dose-Limiting Toxicities (DLTs)
timeFrame: Baseline through Cycle 2 (21 Day Cycles)
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3435151
timeFrame: Cycle 1 Day 1 (C1D1) (Predose, 1, 3 hour (hr), C1D2 (24 hr), C1D4 (72hr), C1D8 (168hr), C1D15 (336hr)
measure: PK: Cmax of LY3435151 in Combination With Pembrolizumab
timeFrame: Predose Cycle 1 Day 1 through Predose Cycle 5 Day 1 (21 Day Cycles)
measure: Overall Response Rate (ORR): Percentage of Participants With Complete Response (CR) or Partial Response (PR)
timeFrame: Baseline through Disease Progression or Death (Up to 4 Months)
measure: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and Stable Disease
timeFrame: Baseline through Measured Progressive Disease (Up to 4 Months)
measure: Duration of Response (DoR)
timeFrame: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 4 Months)
measure: Time to Response (TTR)
timeFrame: Baseline to Date of CR or PR (Up to 4 Months)
measure: Progression Free Survival (PFS)
timeFrame: Baseline to Objective Progression or Death Due to Any Cause (Up to 4 Months)
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Chuo-Ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: