A Study of LY4170156 in Participants With Selected Advanced Solid Tumors

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT06400472
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LY4170156 — DRUG
    Intravenous
  • bevacizumab — DRUG
    IV
  • carboplatin — DRUG
    IV
  • Itraconazole — DRUG
    oral
  • pembrolizumab — DRUG
    IV

Study Details

The purpose of this study is to find out whether the study drug, LY4170156, is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.

Key Dates

Start date
May 20, 2024
Status verified
Jan 2026
Primary completion
Feb 28, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
495 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LY4170156 (Dose-escalation, Cohort A1)
    Escalating doses of LY4170156 administered intravenously (IV)
  • Experimental: LY4170156 (Cohort A1 Parts A and C)
    LY4170156 administered IV
  • Experimental: LY4170156 Alone or with Itraconazole. Drug-Drug Interaction (DDI) (Cohort A1: Arm B)
    LY4170156 administered IV and itraconazole administered orally
  • Experimental: LY4170156 (Dose-optimization, Cohort A2)
    Comparing 2 or more doses (evaluated during dose escalation) of LY4170156 administered IV
  • Experimental: LY4170156 (Enrichment Cohort A3)
    Monotherapy administered IV
  • Experimental: LY4170156 (Combination Cohort A4)
    Combination with bevacizumab administered IV
  • Experimental: LY4170156 (Combination Cohort A5)
    Combination with carboplatin administered IV
  • Experimental: LY4170156 Combination with Pembrolizumab (Dose-optimization Cohort A6)
    Comparing 2 or more doses (evaluated during dose escalation) of LY4170156 administered IV with pembrolizumab
  • Experimental: LY4170156 (Dose-expansion, Cohort B1-B4)
    LY4170156 administered IV

Primary Outcome Measure

Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY4170156 [ Time Frame: 1 Cycle (21 days) ]

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (9)

FacilityCityStateZIPSite coordinators
HonorHealthScottsdaleArizona85258-
University of California, San Diego (UCSD) - Moores Cancer CenterLa JollaCalifornia92037-
South Texas Accelerated Research Therapeutics (START) MidwestGrand RapidsMichigan49546-
NYU Langone Health - Long IslandMineolaNew York11501-
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
New York University (NYU) Clinical Cancer CenterNew YorkNew York10016-
The Ohio State University (OSU) Wexner Medical CenterColumbusOhio43210-
The University of Texas - MD Anderson Cancer CenterHoustonTexas77030-4000-
START Mountain RegionWest Valley CityUtah84119-

Find similar trials in Scottsdale, AZ

By condition
Colorectal cancerOvarian cancer
By specialty
OncologyGI oncologyGynecologic oncologyWomen's health
By research site
HonorHealth· Scottsdale, AZUniversity of California, San Diego (UCSD) - Moores Cancer Center· La Jolla, CASouth Texas Accelerated Research Therapeutics (START) Midwest· Grand Rapids, MINYU Langone Health - Long Island· Mineola, NYDavid H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center· New York, NYNew York University (NYU) Clinical Cancer Center· New York, NY

Related Studies