Solid TumorPhase 1NCT03343613
A Study of LY3381916 Alone or in Combination With LY3300054 in Participants With Solid Tumors
A Phase 1 study testing LY3381916 and LY3300054 in people with Solid Tumor and Non Small Cell Lung Cancer, run by Eli Lilly and Company at 12 sites in 6 countries.
Trial summary
The purpose of this study is to evaluate the safety of the study drug LY3381916 administered alone or in combination with anti-programmed cell death ligand 1 (PD-L1) checkpoint antibody (LY3300054). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Non Small Cell Lung Cancer, Renal Cell Carcinoma
- What is being tested?
- LY3381916 and LY3300054
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 12 sitesin 6 countries
- Study dates
- 17 Nov 2017to 4 May 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dose escalation phase: Participant must have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic.
- Dose expansion B1: Metastatic TNBC participants who have not received prior PD-1/L1 treatment.
- Dose expansion B2: Metastatic NSCLC participants who have progressed on prior PD-L1/L1 treatment.
- Dose expansion B3: Metastatic clear cell carcinoma RCC who have progressed on prior PD-L1/L1 treatment.
- Have adequate organ function.
- Have a performance status (PS) of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
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- Are able and willing to provide required, newly acquired tumor biopsies.
- Have discontinued previous treatments for cancer.
- Are able to swallow capsules.
Who cannot join
- Currently enrolled in a clinical study.
- Have known symptomatic central nervous system metastases or carcinomatous meningitis.
- Have a serious concomitant systemic disorder.
- Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis B or C.
- Have a significant cardiac condition.
- Have previously received an indoleamine- 2,3-dioxygenase (IDO) inhibitor.
- Have an active autoimmune disease or currently require immunosuppression of >10 milligrams of prednisone or equivalent per day.
- Have interstitial lung disease or (noninfectious) pneumonitis, participants with a history of (noninfectious) pneumonitis that required steroids to assist with management.
Trial locations and contacts
12 sites in 6 countries.
12 sites in 6 countries
United States3 sites
IU Simon Cancer Center
Indianapolis, Indiana, 46202
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, 37203
Tennessee Oncology PLLC
Nashville, Tennessee, 37203
Belgium3 sites
Institut Jules Bordet
Brussels, 1000
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Universitair Ziekenhuis Gent
Ghent, 9000
Italy2 sites
Azienda Ospedaliera Umberto I
Ancona, 60100
Azienda Ospedaliera San Gerardo
Monza, Milano, 20052
Spain2 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Clinico Universitario Virgen de la Victoria
Málaga, Andalusia, 29010
About this study
Official title: A Phase 1a/1b Study of an Anti-IDO-1 Agent (LY3381916) Administered Alone or in Combination With Anti- PD-L1 Checkpoint Antibody (LY3300054) in Solid Tumors
The purpose of this study is to evaluate the safety of the study drug LY3381916 administered alone or in combination with anti-programmed cell death ligand 1 (PD-L1) checkpoint antibody (LY3300054).
- Conditions
- Solid Tumor, Non Small Cell Lung Cancer, Renal Cell Carcinoma, Triple Negative Breast Cancer
- Being tested
- LY3381916, LY3300054
- Keywords
- IDO-1 Inhibitor, IDO1 Inhibitor, IDO Inhibitor
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3381916Drug
IDO-1 inhibitor administered orally
LY3300054Drug
PD-L1 inhibitor administered IV
| Study group | Role | What they receive |
|---|---|---|
| LY3381916 Escalation | Experimental | LY3381916 administered orally. Receives: Drug: LY3381916 |
| LY3381916 + LY3300054 Escalation | Experimental | LY3381916 administered orally and LY3300054 administered intravenously (IV). Receives: Drug: LY3381916; Drug: LY3300054 |
| LY3381916 Expansion | Experimental | LY3381916 administered orally. Receives: Drug: LY3381916 |
| LY3381916 + LY3300054 Expansion B1 | Experimental | Metastatic triple negative breast cancer (TNBC)
LY3381916 administered orally and LY3300054 administered IV. Receives: Drug: LY3381916; Drug: LY3300054 |
| LY3381916 + LY3300054 Expansion B2 | Experimental | Metastatic non-small cell lung cancer (NSCLC)
LY3381916 administered orally and LY3300054 administered IV. Receives: Drug: LY3381916; Drug: LY3300054 |
| LY3381916 + LY3300054 Expansion B3 | Experimental | Metastatic clear cell carcinoma renal cell carcinoma (RCC)
LY3381916 administered orally and LY3300054 administered IV. Receives: Drug: LY3381916; Drug: LY3300054 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose Limiting Toxicities (DLTs)
Number of participants with DLTs
Measured: Baseline through Cycle 1 (28 Day Cycle)
Secondary outcomes (11)
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3381916
PK: Cmax of LY3381916
Measured: Predose Lead in Day 1 through Cycle 3 Day 1
PK: Area Under the Plasma Concentration Curve (AUC) of LY3381916
PK: AUC of LY3381916
Measured: Predose Lead in Day 1 through Cycle 3 Day 1
PK: Cmax of LY3381916 Administered in Combination with LY3300054
PK: Cmax of LY3381916 administered in combination with LY3300054
Measured: Predose Cycle 1 Day 1 through Cycle 3 Day 1
PK: AUC of LY3381916 Administered in Combination with LY3300054
PK: AUC of LY3381916 administered in combination with LY3300054
Measured: Predose Cycle 1 Day 1 through Cycle 3 Day 1
PK: Cmax of LY3300054 Administered in Combination with LY3381916
PK: Cmax of LY3300054 administered in combination with LY3381916
Measured: Predose Cycle 1 Day 1 through Cycle 3 Day 1
PK: Minimum Plasma Concentration (Cmin) of LY3300054 Administered in Combination with LY3381916
PK: Cmin of LY3300054 administered in combination with LY3381916
Measured: Predose Cycle 1 Day 1 through Cycle 3 Day 1
Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR)
ORR: Percentage of participants with a CR or PR
Measured: Baseline through Measured Progressive Disease (Estimated up to 12 Months)
Time to Response (TTR)
TTR
Measured: Baseline to Date of CR or PR (Estimated up to 12 Months)
Disease Control Rate (DCR): Percentage of Participants who Exhibit Stable Disease (SD), CR or PR
DCR: Percentage of participants who exhibit SD, CR or PR
Measured: Baseline through Measured Progressive Disease (Estimated up to 12 Months)
Duration of Response (DOR)
DOR
Measured: Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)
Progression Free Survival (PFS)
PFS
Measured: Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 12 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start17 Nov 2017
- Primary completion7 Feb 2020
- Study completion4 May 2020
Why it stopped: Study terminated due to strategic business decision by Eli Lilly and Company.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343613
- Sponsor's protocol ID
- 16786
- Other IDs
- I9L-MC-JZCA, 2017-002693-39, 2017
- Status last verified
- Jun 2020
- First submitted
- 9 Nov 2017
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b Study of an Anti-IDO-1 Agent (LY3381916) Administered Alone or in Combination With Anti- PD-L1 Checkpoint Antibody (LY3300054) in Solid Tumors
- ClinicalTrials.gov ID
- NCT03343613
- Acronym / sponsor ID
- 16786
- Conditions
- Solid Tumor, Non Small Cell Lung Cancer, Renal Cell Carcinoma, Triple Negative Breast Cancer
- Keywords
- IDO-1 Inhibitor, IDO1 Inhibitor, IDO Inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to strategic business decision by Eli Lilly and Company.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 4 May 2020 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety of the study drug LY3381916 administered alone or in combination with anti-programmed cell death ligand 1 (PD-L1) checkpoint antibody (LY3300054).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| LY3381916 Escalation | Experimental | Drug: LY3381916LY3381916 administered orally. |
| LY3381916 + LY3300054 Escalation | Experimental | Drug: LY3381916, Drug: LY3300054LY3381916 administered orally and LY3300054 administered intravenously (IV). |
| LY3381916 Expansion | Experimental | Drug: LY3381916LY3381916 administered orally. |
| LY3381916 + LY3300054 Expansion B1 | Experimental | Drug: LY3381916, Drug: LY3300054Metastatic triple negative breast cancer (TNBC) LY3381916 administered orally and LY3300054 administered IV. |
| LY3381916 + LY3300054 Expansion B2 | Experimental | Drug: LY3381916, Drug: LY3300054Metastatic non-small cell lung cancer (NSCLC) LY3381916 administered orally and LY3300054 administered IV. |
| LY3381916 + LY3300054 Expansion B3 | Experimental | Drug: LY3381916, Drug: LY3300054Metastatic clear cell carcinoma renal cell carcinoma (RCC) LY3381916 administered orally and LY3300054 administered IV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Dose escalation phase: Participant must have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic.
- Dose expansion B1: Metastatic TNBC participants who have not received prior PD-1/L1 treatment.
- Dose expansion B2: Metastatic NSCLC participants who have progressed on prior PD-L1/L1 treatment.
- Dose expansion B3: Metastatic clear cell carcinoma RCC who have progressed on prior PD-L1/L1 treatment.
- Have adequate organ function.
Key exclusion criteria (8 listed)
- Currently enrolled in a clinical study.
- Have known symptomatic central nervous system metastases or carcinomatous meningitis.
- Have a serious concomitant systemic disorder.
- Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis B or C.
- Have a significant cardiac condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY3381916IDO-1 inhibitor administered orally | Drug | LY3381916 + LY3300054 Escalation, LY3381916 + LY3300054 Expansion B1, LY3381916 + LY3300054 Expansion B2, LY3381916 + LY3300054 Expansion B3, LY3381916 Escalation, LY3381916 Expansion |
| LY3300054PD-L1 inhibitor administered IV | Drug | LY3381916 + LY3300054 Escalation, LY3381916 + LY3300054 Expansion B1, LY3381916 + LY3300054 Expansion B2, LY3381916 + LY3300054 Expansion B3 |
Primary outcome
Number of Participants with Dose Limiting Toxicities (DLTs)
Time frame: Baseline through Cycle 1 (28 Day Cycle)
Number of participants with DLTs
11 secondary outcomes
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3381916
Time frame: Predose Lead in Day 1 through Cycle 3 Day 1
PK: Area Under the Plasma Concentration Curve (AUC) of LY3381916
Time frame: Predose Lead in Day 1 through Cycle 3 Day 1
PK: Cmax of LY3381916 Administered in Combination with LY3300054
Time frame: Predose Cycle 1 Day 1 through Cycle 3 Day 1
PK: AUC of LY3381916 Administered in Combination with LY3300054
Time frame: Predose Cycle 1 Day 1 through Cycle 3 Day 1
PK: Cmax of LY3300054 Administered in Combination with LY3381916
Time frame: Predose Cycle 1 Day 1 through Cycle 3 Day 1
PK: Minimum Plasma Concentration (Cmin) of LY3300054 Administered in Combination with LY3381916
Time frame: Predose Cycle 1 Day 1 through Cycle 3 Day 1
Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR)
Time frame: Baseline through Measured Progressive Disease (Estimated up to 12 Months)
Time to Response (TTR)
Time frame: Baseline to Date of CR or PR (Estimated up to 12 Months)
Disease Control Rate (DCR): Percentage of Participants who Exhibit Stable Disease (SD), CR or PR
Time frame: Baseline through Measured Progressive Disease (Estimated up to 12 Months)
Duration of Response (DOR)
Time frame: Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)
Progression Free Survival (PFS)
Time frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 12 Months)
Results and safety
The study was stopped early (reason given: Study terminated due to strategic business decision by Eli Lilly and Company.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- A Study of LY3381916 Alone or in Combination With LY3300054 in Participants With Solid TumorsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
12 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3381916 and LY3300054 in people with Solid Tumor and Non Small Cell Lung Cancer, run by Eli Lilly and Company at 12 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Belgium, Italy, Spain, Denmark and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study terminated due to strategic business decision by Eli Lilly and Company.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Dose Limiting Toxicities (DLTs) (time frame: Baseline through Cycle 1 (28 Day Cycle)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.