A Study of LY3435151 in Participants With Solid Tumors

Brief Title

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

Brief Summary

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


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Number of Participants with LY3435151 Dose-Limiting Toxicities (DLTs)

Secondary Outcome

 Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3435151

Condition

Solid Tumor

Intervention

LY3435151

Study Arms / Comparison Groups

 LY3435151 Dose Escalation
Description:  LY3435151 administered intravenously (IV).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

2

Start Date

October 28, 2019

Completion Date

March 5, 2020

Primary Completion Date

March 5, 2020

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

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), , 

Location Countries

Japan

Location Countries

Japan

Administrative Informations


NCT ID

NCT04099277

Organization ID

17364

Secondary IDs

J1Q-MC-JZIA

Responsible Party

Sponsor

Study Sponsor

Eli Lilly and Company


Study Sponsor

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), Study Director, Eli Lilly and Company


Verification Date

April 2020