Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSD
Dates
study started
estimated completion
Principal Investigator
Lyudmila Bazhenova (ucsd)Jonathan W Goldman (ucla)
Photo of Lyudmila Bazhenova
Lyudmila Bazhenova

Description

Summary

The main purpose of this study is to investigate the safety of LY3405105 in participants with advanced cancer. The study has two parts phase 1a and phase 1b. Participants will only enroll in one part.

Official Title

A Phase 1a/1b Study of LY3405105 Administered to Patients With Advanced Solid Tumors

Keywords

Solid Tumor

Eligibility

You can join if…

Open to people ages 18 years and up

Phase 1 a:

  • Have histological or cytological evidence of a diagnosis of a solid tumor cancer that is advanced and/or metastatic
  • Have available archived tissue for exploratory biomarker analysis
  • Have adequate organ function
  • Have discontinued all previous treatments for cancer and recovered from their side effects
  • Are able to swallow capsules/tablets

Phase 1 b:

  • Cohort 1: Triple-negative breast cancer (TNBC).
  • Cohort 2: Clear cell ovarian cancer, endometrioid ovarian cancer, or endometrioid endometrial carcinoma with a LOF mutation in one or more of the following genes: ARID1A, KMT2C (MLL3), KMT2D (MLL2), or KDM6A (UTX).
  • Cohort 3: Soft tissue sarcoma or sarcomatoid/rhabdoid malignancy with loss of expression of INI1, BRG1, or BRM by immunohistochemistry or a LOF mutation in one or more of the following genes: ARID1A, SMARCA2, SMARCA4, or SMARCB1. Participants aged ≥ 12 years with a body weight of ≥ 40 kilogram (kg) are acceptable for Cohorts 3. Participants with synovial sarcoma and a confirmed SS18-SSX gene fusion are also eligible.
  • Cohort 4: Epithelioid sarcoma with INI1 loss of expression by immunohistochemistry or SMARCB1 LOF mutation. Participants aged ≥ 12 years with a body weight of ≥ 40 kilogram (kg) are acceptable for Cohorts 4.
  • Cohort 5: Bladder cancer with a LOF mutation in one or more of the following genes: ARID1A, KMT2C (MLL3), KMT2D (MLL2), or KDM6A (UTX).

You CAN'T join if...

  • Have symptomatic central nervous system (CNS) malignancy or metastasis
  • Have symptomatic human immunodeficiency virus (HIV), Hepatitis A, B, or C
  • Have congestive heart failure
  • Are breastfeeding

Locations

  • University of California - San Diego not yet accepting patients
    La Jolla California 92037-0845 United States
  • UCLA Medical Center not yet accepting patients
    Los Angeles California 90024 United States
  • UCLA Medical Center not yet accepting patients
    Los Angeles California 90095 United States

Lead Scientists at UC Health

  • Lyudmila Bazhenova (ucsd)
    Dr. Bazhenova’s clinical practice and research concentrate on lung cancer, particularly as this relates to females and non-smokers. She actively participates in cooperative group trials, and takes an active role in designing and implementing clinical investigations, including phase II studies and correlative science projects with several UCSD investigators.
  • Jonathan W Goldman (ucla)

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
A Study of LY3405105 in Participants With Advanced Cancer
ID
NCT03770494
Phase
Phase 1
Study Type
Interventional
Last Updated