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A Study of LY3499446 in Participants With Advanced Solid Tumors With KRAS G12C Mutation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04165031
Recruitment Status : Terminated (The study was terminated due to an unexpected toxicity finding.)
First Posted : November 15, 2019
Results First Posted : November 24, 2021
Last Update Posted : November 24, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Advanced Solid Tumor
Non-Small Cell Lung Cancer
Colorectal Cancer
Interventions Drug: LY3499446
Drug: Abemaciclib
Drug: Cetuximab
Drug: Erlotinib
Drug: Docetaxel
Enrollment 5
Recruitment Details  
Pre-assignment Details

A participant was identified as having completed the study if the participant was observed until event of progressive disease (PD) or death, or the participant had discontinued study treatment and is in follow up at the time of the final analysis.

The study was terminated due to an unexpected toxicity finding.

Arm/Group Title LY3499446 Phase 1 Cohort A1 (High Dose) LY3499446 Phase 1 Cohort AO (Mid Dose) LY3499446 Phase 1 Cohort A-2 (Low Dose) LY3499446 + Combination Drug Phase 1 LY3499446 Monotherapy + Combination Drug Phase 2 Docetaxel Phase 2
Hide Arm/Group Description Participants received high dose LY3499446 as oral monotherapy twice daily (BID) in 21-day cycles. Participant received mid dose LY3499446 as oral monotherapy once every other day (QOD) in 21-day cycles. Participants received low dose LY 3499446 as oral monotherapy once daily (QD) in 21-day cycles.

LY3499446 combined with either abemaciclib (orally), erlotinib (orally), or cetuximab (IV).

The trial was terminated prior to initiation of this portion.

LY3499446 monotherapy orally. LY3499446 combined with either abemaciclib (orally), erlotinib (orally), or cetuximab (IV).

The trial was terminated prior to initiation of this portion.

Docetaxel IV infusion.

The trial was terminated prior to initiation of this portion.

Period Title: Overall Study
Started 2 1 2 0 0 0
Received at Least One Dose of Study Drug 2 1 2 0 0 0
Completed 1 0 1 0 0 0
Not Completed 1 1 1 0 0 0
Reason Not Completed
Adverse Event             1             1             0             0             0             0
Withdrawal by Subject             0             0             1             0             0             0
Arm/Group Title LY3499446 Phase 1 Cohort A1 (High Dose) LY3499446 Phase 1 Cohort AO (Mid Dose) LY3499446 Phase 1 Cohort A-2 (Low Dose) LY3499446 + Combination Drug Phase 1 LY3499446 Monotherapy + Combination Drug Phase 2 Docetaxel Phase 2 Total
Hide Arm/Group Description Participants received high dose LY3499446 as oral monotherapy BID in 21-day cycles. Participant received mid dose LY3499446 as oral monotherapy once QOD in 21-day cycles. Participants received low dose LY 3499446 as oral monotherapy once QD in 21-day cycles.

LY3499446 combined with either abemaciclib (orally), erlotinib (orally), or cetuximab (IV).

The trial was terminated prior to initiation of this portion.

LY3499446 monotherapy orally. LY3499446 combined with either abemaciclib (orally), erlotinib (orally), or cetuximab (IV).

The trial was terminated prior to initiation of this portion.

Docetaxel IV infusion.

The trial was terminated prior to initiation of this portion.

Total of all reporting groups
Overall Number of Baseline Participants 2 1 2 0 0 0 5
Hide Baseline Analysis Population Description
All participants who received at least one dose of study drug
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 2 participants 0 participants 0 participants 0 participants 5 participants
<=18 years 0 0 0 0 0 0 0
Between 18 and 65 years 1 0 0 0 0 0 1
>=65 years 1 1 2 0 0 0 4
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 2 participants 0 participants 0 participants 0 participants 5 participants
Female 1 1 2 0 0 0 4
Male 1 0 0 0 0 0 1
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 2 participants 0 participants 0 participants 0 participants 5 participants
Hispanic or Latino 0 0 0 0 0 0 0
Not Hispanic or Latino 2 1 2 0 0 0 5
Unknown or Not Reported 0 0 0 0 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 2 participants 0 participants 0 participants 0 participants 5 participants
American Indian or Alaska Native 0 0 0 0 0 0 0
Asian 0 0 0 0 0 0 0
Native Hawaiian or Other Pacific Islander 0 0 0 0 0 0 0
Black or African American 0 0 0 0 0 0 0
White 2 1 2 0 0 0 5
More than one race 0 0 0 0 0 0 0
Unknown or Not Reported 0 0 0 0 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 2 participants 0 participants 0 participants 0 participants 5 participants
United States 0 1 2 0 0 0 3
Australia 2 0 0 0 0 0 2
1.Primary Outcome
Title Phase 1: Number or Participants With Dose Limiting Toxicities (DLTs)
Hide Description DLT is defined as an event that is clinically significant and not clearly related to disease progression or intercurrent illness that occurred within the DLT observation period of the Cycle 1 timeframe.
Time Frame Cycle 1 (21 Day Cycle)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug and had a dose limiting toxicity.
Arm/Group Title LY3499446 Phase 1 Cohort A1 (High Dose) LY3499446 Phase 1 Cohort AO (Mid Dose) LY3499446 Phase 1 Cohort A-2 (Low Dose)
Hide Arm/Group Description:
Participants received high dose LY3499446 as oral monotherapy BID in 21-day cycles.
Participant received mid dose LY3499446 as oral monotherapy once QOD in 21-day cycles.
Participants received low dose LY3499446 as oral monotherapy once QD in 21-day cycles.
Overall Number of Participants Analyzed 2 1 2
Measure Type: Count of Participants
Unit of Measure: Participants
2 1 1
2.Primary Outcome
Title Phase 2: Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) in Colorectal Cancer (CRC) Cohorts and Other Tumors Cohort
Hide Description ORR is defined as percentage of participants who achieved a CR or PR out of all the participants treated. Tumor responses were measured and record using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST) v1.1 guidelines. CR is defined as the disappearance of all targeted and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions and no appearance of new lesions.
Time Frame Baseline through Measured Progressive Disease
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed due to early termination of study.
Arm/Group Title LY3499446 Monotherapy + Combination Drugs Phase 2 Docetaxel Phase 2
Hide Arm/Group Description:
LY3499446 combined with either abemaciclib (orally), erlotinib (orally), or cetuximab (IV).
Docetaxel IV infusion.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Phase 2: Progression-Free Survival (PFS) Non-Small Lung Cancer (NSCLC Cohorts)
Hide Description PFS was defined as the time from study enrollment (for non-randomized cohorts)/ the time from randomization (for randomized cohorts) to the first observation of progressive disease (PD) or death without documented disease progression per RECIST V1.1 criteria.
Time Frame Baseline to Objective Progression or Death Due to Any Cause
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed due to early termination of study.
Arm/Group Title LY3499446 Monotherapy + Combination Drugs Phase 2 Docetaxel Phase 2
Hide Arm/Group Description:
LY3499446 combined with either abemaciclib (orally), erlotinib (orally), or cetuximab (IV).
Docetaxel IV infusion.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Phase 1: Pharmacokinetics (PK): Average Concentration of LY3499446
Hide Description Average concentration after the first dose of LY3499446.
Time Frame Cycle 1 Day 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 8, 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who have received at least one dose of study drug and had evaluable PK.
Arm/Group Title LY3499446 Phase 1 Cohort A1 (High Dose) LY3499446 Phase 1 Cohort AO (Mid Dose) LY3499446 Phase 1 Cohort A-2 (Low Dose)
Hide Arm/Group Description:
Participants received high dose LY3499446 as oral monotherapy BID in 21-day cycles.
Participant received mid dose LY3499446 as oral monotherapy once QOD in 21-day cycles.
Participants received low dose LY3499446 as oral monotherapy once QD in 21-day cycles.
Overall Number of Participants Analyzed 2 1 2
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms per milliliter (ng/mL)
NA [1] 
(NA%)
NA [2] 
(NA%)
NA [3] 
(NA%)
[1]
N=2: Geometric mean and Geometric Coefficient of Variation were not calculated, individual values reported:1056 ng/mL and 570 ng/mL.
[2]
N=1: Geometric mean and Geometric Coefficient of Variation were not calculated, individual values reported: 865 ng/mL.
[3]
N=2: Geometric mean and Geometric Coefficient of Variation were not calculated, individual values reported: 225 ng/mL and 116 ng/mL.
5.Secondary Outcome
Title Phase 1: PK: Average Concentration at Steady State of LY3499446 in Combination With Abemaciclib
Hide Description PK: Average Concentration at Steady State of LY3499446 in Combination with Abemaciclib
Time Frame Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles)
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed due to early termination of study.
Arm/Group Title LY3499446 and Abemaciclib Phase 1
Hide Arm/Group Description:
LY3499446 in combination with abemaciclib orally.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Phase 1: PK: Average Concentration at Steady State of LY3499446 in Combination With Cetuximab
Hide Description PK: Average Concentration at Steady State of LY3499446 in Combination with Cetuximab
Time Frame Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles)
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed due to early termination of study.
Arm/Group Title LY3499446 and Cetuximab Phase 1
Hide Arm/Group Description:
LY3499446 in combination with cetuximab intravenously (IV).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Phase 1: PK: Average Concentration at Steady State of LY3499446 in Combination With Erlotinib
Hide Description PK: Average Concentration at Steady State of LY3499446 in Combination with Erlotinib
Time Frame Predose Cycle 1 Day 1 through Cycle 3 Day 1 (21 Day Cycles)
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed due to early termination of study.
Arm/Group Title LY3499446 Monotherapy and Erlotinib Phase 1
Hide Arm/Group Description:
LY3499446 in combination with erlotinib orally.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Phase 1: ORR: Percentage of Participants Who Achieve CR or PR
Hide Description ORR is defined as percentage of participants who achieved a CR or PR out of all the participants treated. Tumor responses were measured and record using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST) v1.1 guidelines. CR is defined as the disappearance of all targeted and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions and no appearance of new lesions.
Time Frame Baseline through Measured Progressive Disease (Up to 11 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed due to early termination of study.
Arm/Group Title LY3499446 Phase 1 Cohort A1 (High Dose) LY3499446 Phase 1 Cohort AO (Mid Dose) LY3499446 Phase 1 Cohort A-2 (Low Dose)
Hide Arm/Group Description:
Participants received high dose LY3499446 as oral monotherapy BID in 21-day cycles.
Participant received mid dose LY3499446 as oral monotherapy once QOD in 21-day cycles.
Participants received low dose LY3499446 as oral monotherapy once QD in 21-day cycles.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Phase 1: PFS
Hide Description PFS was defined as the time from study enrollment (for non-randomized cohorts)/ the time from randomization (for randomized cohorts) to the first observation of progressive disease (PD) overall response or death without documented disease progression per RECIST V1.1 criteria.
Time Frame Baseline to Objective Progression or Death Due to Any Cause (Up to 11 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed due to early termination of study.
Arm/Group Title LY3499446 Phase 1 Cohort A1 (High Dose) LY3499446 Phase 1 Cohort AO (Mid Dose) LY3499446 Phase 1 Cohort A-2 (Low Dose)
Hide Arm/Group Description:
Participants received high dose LY3499446 as oral monotherapy BID in 21-day cycles.
Participant received mid dose LY3499446 as oral monotherapy QOD in 21-day cycles.
Participants received low dose LY3499446 as oral monotherapy QD in 21-day cycles in 21-day cycles.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Phase 1: Duration of Response (DoR)
Hide Description DoR was defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST v1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence.
Time Frame Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Up to 11 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed due to early termination of study.
Arm/Group Title LY3499446 Phase 1 Cohort A1 (High Dose) LY3499446 Phase 1 Cohort AO (Mid Dose) LY3499446 Phase 1 Cohort A-2 (Low Dose)
Hide Arm/Group Description:
Participants received high dose LY3499446 as oral monotherapy BID in 21-day cycles.
Participant received mid dose LY3499446 as oral monotherapy once QOD in 21-day cycles.
Participants received low dose LY3499446 as oral monotherapy once QD in 21-day cycles.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Phase 1: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and SD
Hide Description DCR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed CR, confirmed PR, or SD out of all participants treatment. Best response is determined from a sequence of responses assessed. Two determinations of PR or better before progression, but not qualifying for a CR, are required for a best response of PR. CR is defined as the disappearance of all targeted and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions and no appearance of new lesions.
Time Frame Baseline through Measured Progressive Disease (Up to 11 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed due to early termination of study.
Arm/Group Title LY3499446 Phase 1 Cohort A1 (High Dose) LY3499446 Phase 1 Cohort AO (Mid Dose) LY3499446 Phase 1 Cohort A-2 (Low Dose)
Hide Arm/Group Description:
Participants received high dose LY3499446 as oral monotherapy BID in 21-day cycles.
Participant received mid dose LY3499446 as oral monotherapy once QOD in 21-day cycles.
Participants received low dose LY3499446 as oral monotherapy once QD in 21-day cycles.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Baseline up to 11 months
Adverse Event Reporting Description All participants who received at least one dose of study drug.
 
Arm/Group Title LY3499446 Phase 1 Cohort A1 (High Dose) LY3499446 Phase 1 Cohort AO (Mid Dose) LY3499446 Phase 1 Cohort A-2 (Low Dose)
Hide Arm/Group Description Participants received high dose LY3499446 as oral monotherapy twice daily (BID) in 21-day cycles. Participant received mid dose LY3499446 as oral monotherapy once every other day (QOD) in 21-day cycles. Participants received low dose LY3499446 as monotherapy orally once QD in 21-day cycles.
All-Cause Mortality
LY3499446 Phase 1 Cohort A1 (High Dose) LY3499446 Phase 1 Cohort AO (Mid Dose) LY3499446 Phase 1 Cohort A-2 (Low Dose)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/2 (50.00%)      0/1 (0.00%)      1/2 (50.00%)    
Hide Serious Adverse Events
LY3499446 Phase 1 Cohort A1 (High Dose) LY3499446 Phase 1 Cohort AO (Mid Dose) LY3499446 Phase 1 Cohort A-2 (Low Dose)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      0/1 (0.00%)      1/2 (50.00%)    
General disorders       
Pyrexia  1  0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  2  0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1
Hypoxia  2  0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1
Pleural effusion  2  0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1
Respiratory failure  2  0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1
1
Term from vocabulary, MedDRA 23.0
2
Term from vocabulary, MedDRA 23.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
LY3499446 Phase 1 Cohort A1 (High Dose) LY3499446 Phase 1 Cohort AO (Mid Dose) LY3499446 Phase 1 Cohort A-2 (Low Dose)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/2 (100.00%)      1/1 (100.00%)      2/2 (100.00%)    
Blood and lymphatic system disorders       
Anaemia  1  0/2 (0.00%)  0 1/1 (100.00%)  1 0/2 (0.00%)  0
Haemolysis  2  2/2 (100.00%)  2 1/1 (100.00%)  1 1/2 (50.00%)  1
Leukocytosis  3  0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1
Cardiac disorders       
Cardiac arrest  3  0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1
Palpitations  3  0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  2
Gastrointestinal disorders       
Constipation  2  0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1
Nausea  3  0/2 (0.00%)  0 0/1 (0.00%)  0 2/2 (100.00%)  4
General disorders       
Fatigue  3  0/2 (0.00%)  0 0/1 (0.00%)  0 2/2 (100.00%)  3
Infections and infestations       
Urinary tract infection  2  0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1
Investigations       
Blood bilirubin increased  1  2/2 (100.00%)  3 1/1 (100.00%)  1 0/2 (0.00%)  0
Haptoglobin decreased  3  0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1
Metabolism and nutrition disorders       
Decreased appetite  3  0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1
Musculoskeletal and connective tissue disorders       
Arthralgia  2  0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1
Back pain  3  0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1
Flank pain  2  0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1
Pain in extremity  3  0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1
Nervous system disorders       
Amnesia  1  1/2 (50.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0
Dizziness  1  1/2 (50.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0
Dysgeusia  2  0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1
Headache  1  1/2 (50.00%)  1 0/1 (0.00%)  0 0/2 (0.00%)  0
Paraesthesia  2  0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1
Respiratory, thoracic and mediastinal disorders       
Cough  3  0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1
Dyspnoea  2  1/2 (50.00%)  2 0/1 (0.00%)  0 1/2 (50.00%)  1
Skin and subcutaneous tissue disorders       
Pruritus  3  0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1
Skin hyperpigmentation  2  0/2 (0.00%)  0 0/1 (0.00%)  0 1/2 (50.00%)  1
1
Term from vocabulary, MedDRA 22.1
2
Term from vocabulary, MedDRA 23.0
3
Term from vocabulary, MedDRA 23.1
Indicates events were collected by systematic assessment
The study was terminated due to an unexpected toxicity finding.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
EMail: ClinicalTrials.gov@lilly.com
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04165031    
Other Study ID Numbers: 17501
J2K-MC-JZKA ( Other Identifier: Eli Lilly and Company )
2019-003070-53 ( EudraCT Number )
First Submitted: November 14, 2019
First Posted: November 15, 2019
Results First Submitted: October 27, 2021
Results First Posted: November 24, 2021
Last Update Posted: November 24, 2021