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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04165031




Registration number
NCT04165031
Ethics application status
Date submitted
14/11/2019
Date registered
15/11/2019
Date last updated
22/04/2020

Titles & IDs
Public title
A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation
Scientific title
A Phase 1/2 Study of LY3499446 Administered to Patients With Advanced Solid Tumors With KRAS G12C Mutation
Secondary ID [1] 0 0
J2K-MC-JZKA
Secondary ID [2] 0 0
17501
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Non-Small Cell Lung Cancer 0 0
Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LY3499446
Treatment: Drugs - Abemaciclib
Treatment: Drugs - Cetuximab
Treatment: Drugs - Erlotinib
Treatment: Drugs - Docetaxel

Experimental: LY3499446 Phase 1 - Participants given LY3499446 monotherapy orally.

Experimental: LY3499446 + Abemaciclib Phase 1 - Participants given LY3499446 and abemaciclib orally.

Experimental: LY3499446 + Cetuximab Phase 1 - Participants given LY3499446 orally and cetuximab intravenously (IV).

Experimental: LY3499446 + Erlotinib Phase 1 - Participants given LY3499446 and erlotinib orally.

Experimental: LY3499446 Phase 2 - Participants given LY3499446 monotherapy orally.

Experimental: LY3499446 + Abemaciclib Phase 2 - Participants given LY3499446 and abemaciclib orally.

Experimental: LY3499446 + Erlotinib Phase 2 - Participants given LY3499446 and erlotinib orally.

Experimental: LY3499446 + Cetuximab Phase 2 - Participants given LY3499446 orally and cetuximab IV.

Active Comparator: Docetaxel Phase 2 - Participants given docetaxel IV.


Treatment: Drugs: LY3499446
Administered orally

Treatment: Drugs: Abemaciclib
Administered orally

Treatment: Drugs: Cetuximab
Administered IV

Treatment: Drugs: Erlotinib
Administered orally

Treatment: Drugs: Docetaxel
Administered IV

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1: Number or Participants with Dose Limiting Toxicities (DLTs) - Phase 1: Number or Participants with DLTs
Timepoint [1] 0 0
Cycle 1 (21 Day Cycle)
Primary outcome [2] 0 0
Phase 2: Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) (CRC Cohorts and Other Tumors Cohort) - Phase 2: ORR: Percentage of Participants Who Achieve CR or PR (CRC Cohorts and Other Tumors Cohort)
Timepoint [2] 0 0
Baseline through Measured Progressive Disease (Estimated up to 24 Months)
Primary outcome [3] 0 0
Phase 2: Progression-Free Survival (PFS) (NSCLC Cohorts) - Phase 2: PFS (NSCLC Cohorts)
Timepoint [3] 0 0
Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 24 Months)
Secondary outcome [1] 0 0
Pharmacokinetics (PK): Average Concentration at Steady State of LY3499446 - PK: Average Concentration at Steady State of LY3499446
Timepoint [1] 0 0
Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles)
Secondary outcome [2] 0 0
PK: Average Concentration at Steady State of LY3499446 in Combination with Abemaciclib - PK: Average Concentration at Steady State of LY3499446 in Combination with Abemaciclib
Timepoint [2] 0 0
Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles)
Secondary outcome [3] 0 0
PK: Average Concentration at Steady State of LY3499446 in Combination with Cetuximab - PK: Average Concentration at Steady State of LY3499446 in Combination with Cetuximab
Timepoint [3] 0 0
Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles)
Secondary outcome [4] 0 0
PK: Average Concentration at Steady State of LY3499446 in Combination with Erlotinib - PK: Average Concentration at Steady State of LY3499446 in Combination with Erlotinib
Timepoint [4] 0 0
Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles)
Secondary outcome [5] 0 0
Phase 1: ORR: Percentage of Participants Who Achieve CR or PR - Phase 1: ORR: Percentage of Participants Who Achieve CR or PR
Timepoint [5] 0 0
Baseline through Measured Progressive Disease (Estimated up to 24 Months)
Secondary outcome [6] 0 0
Phase 1: PFS - Phase 1: PFS
Timepoint [6] 0 0
Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 24 Months)
Secondary outcome [7] 0 0
Duration of Response (DoR) - DoR
Timepoint [7] 0 0
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 24 Months)
Secondary outcome [8] 0 0
Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and SD - Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, and SD
Timepoint [8] 0 0
Baseline through Measured Progressive Disease (Estimated up to 24 Months)

Eligibility
Key inclusion criteria
- Participants must have diagnosis of a solid tumor with KRAS G12C mutation that did not
respond to at least 1 line of standard therapy and has spread to other part(s) of the
body

- For phase II, participants must be willing to have new tumor tissue biopsies (doctor
removes a small amount of tissue) during the study if it does not cause undue risks to
health

- Participants must be willing to use highly effective birth control

- Participants must have adequate organ function

- Participants must be able to swallow capsules
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants must not have certain infections such as hepatitis or tuberculosis or HIV
that is not well controlled

- Participants must not have another serious medical condition including a serious heart
condition, such as congestive heart failure, unstable angina pectoris, or heart attack
within the last three months

- Participants must not have cancer of the central nervous system that is not stable

- Participants must not be pregnant or breastfeeding

- Participants must not use herbal supplements

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
Linear Clinical Research Ltd - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
New Hampshire
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Oklahoma
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Italy
State/province [15] 0 0
Milano
Country [16] 0 0
Japan
State/province [16] 0 0
Chiba
Country [17] 0 0
Japan
State/province [17] 0 0
Shizuoka
Country [18] 0 0
Japan
State/province [18] 0 0
Tokyo
Country [19] 0 0
Spain
State/province [19] 0 0
Barcelona
Country [20] 0 0
Spain
State/province [20] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The reason for this study is to see if the study drug LY3499446 is safe and effective in
participants with solid tumors with KRAS G12C mutation.
Trial website
https://clinicaltrials.gov/show/NCT04165031
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04165031