A Study of LY3381916 Alone or in Combination With LY3300054 in Participants With Solid Tumors

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03343613
• Collaborator: (none)
• Enrollment: 60
• Locations: 12
• Arms: 6
• Actual Duration (Months): 29.5
• Patients Per Site: 5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor; Non Small Cell Lung Cancer; Renal Cell Carcinoma; Triple Negative Breast Cancer	Drug: LY3381916; Drug: LY3300054	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Nov 17, 2017
• Actual Primary Completion Date: Feb 7, 2020
• Actual Study Completion Date: May 4, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3381916 Escalation LY3381916 administered orally.	Drug: LY3381916; IDO-1 inhibitor administered orally
Experimental: LY3381916 + LY3300054 Escalation LY3381916 administered orally and LY3300054 administered intravenously (IV).	Drug: LY3381916; IDO-1 inhibitor administered orally; Drug: LY3300054; PD-L1 inhibitor administered IV
Experimental: LY3381916 Expansion LY3381916 administered orally.	Drug: LY3381916; IDO-1 inhibitor administered orally
Experimental: LY3381916 + LY3300054 Expansion B1 Metastatic triple negative breast cancer (TNBC) LY3381916 administered orally and LY3300054 administered IV.	Drug: LY3381916; IDO-1 inhibitor administered orally; Drug: LY3300054; PD-L1 inhibitor administered IV
Experimental: LY3381916 + LY3300054 Expansion B2 Metastatic non-small cell lung cancer (NSCLC) LY3381916 administered orally and LY3300054 administered IV.	Drug: LY3381916; IDO-1 inhibitor administered orally; Drug: LY3300054; PD-L1 inhibitor administered IV
Experimental: LY3381916 + LY3300054 Expansion B3 Metastatic clear cell carcinoma renal cell carcinoma (RCC) LY3381916 administered orally and LY3300054 administered IV.	Drug: LY3381916; IDO-1 inhibitor administered orally; Drug: LY3300054; PD-L1 inhibitor administered IV

Outcome Measures

Primary Outcome Measures

1. Number of Participants with Dose Limiting Toxicities (DLTs) [Baseline through Cycle 1 (28 Day Cycle)]

   Number of participants with DLTs

Secondary Outcome Measures

1. Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3381916 [Predose Lead in Day 1 through Cycle 3 Day 1]

   PK: Cmax of LY3381916

2. PK: Area Under the Plasma Concentration Curve (AUC) of LY3381916 [Predose Lead in Day 1 through Cycle 3 Day 1]

   PK: AUC of LY3381916

3. PK: Cmax of LY3381916 Administered in Combination with LY3300054 [Predose Cycle 1 Day 1 through Cycle 3 Day 1]

   PK: Cmax of LY3381916 administered in combination with LY3300054

4. PK: AUC of LY3381916 Administered in Combination with LY3300054 [Predose Cycle 1 Day 1 through Cycle 3 Day 1]

   PK: AUC of LY3381916 administered in combination with LY3300054

5. PK: Cmax of LY3300054 Administered in Combination with LY3381916 [Predose Cycle 1 Day 1 through Cycle 3 Day 1]

   PK: Cmax of LY3300054 administered in combination with LY3381916

6. PK: Minimum Plasma Concentration (Cmin) of LY3300054 Administered in Combination with LY3381916 [Predose Cycle 1 Day 1 through Cycle 3 Day 1]

   PK: Cmin of LY3300054 administered in combination with LY3381916

7. Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR) [Baseline through Measured Progressive Disease (Estimated up to 12 Months)]

   ORR: Percentage of participants with a CR or PR

8. Time to Response (TTR) [Baseline to Date of CR or PR (Estimated up to 12 Months)]

   TTR

9. Disease Control Rate (DCR): Percentage of Participants who Exhibit Stable Disease (SD), CR or PR [Baseline through Measured Progressive Disease (Estimated up to 12 Months)]

   DCR: Percentage of participants who exhibit SD, CR or PR

10. Duration of Response (DOR) [Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)]

    DOR

11. Progression Free Survival (PFS) [Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 12 Months)]

    PFS

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

• Are able and willing to provide required, newly acquired tumor biopsies.

• Have discontinued previous treatments for cancer.

• Are able to swallow capsules.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IU Simon Cancer Center	Indianapolis	Indiana	United States	46202
2	Sarah Cannon Research Institute SCRI	Nashville	Tennessee	United States	37203
3	Tennessee Oncology PLLC	Nashville	Tennessee	United States	37203
4	Institut Jules Bordet	Brussel		Belgium	1000
5	Universitair Ziekenhuis Antwerpen	Edegem		Belgium	2650
6	Universitair Ziekenhuis Gent	Gent		Belgium	9000
7	Finsen Institute	Copenhagen		Denmark	2100
8	Gustave Roussy	Villejuif Cedex		France	94805
9	Azienda Ospedaliera San Gerardo	Monza	Milano	Italy	20052
10	Azienda Ospedaliera Umberto I	Ancona		Italy	60100
11	Hospital Clinico Universitario Virgen de la Victoria	Malaga	Andalucia	Spain	29010
12	Hospital Universitari Vall d'Hebron	Barcelona		Spain	08035

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: 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), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• A Study of LY3381916 Alone or in Combination With LY3300054 in Participants With Solid Tumors

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT03343613
• Other Study ID Numbers: 16786; I9L-MC-JZCA; 2017-002693-39
• First Posted: Nov 17, 2017
• Last Update Posted: Jun 9, 2020
• Last Verified: Jun 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Eli Lilly and Company: IDO-1 Inhibitor; IDO1 Inhibitor; IDO Inhibitor
• Additional relevant MeSH terms: Carcinoma, Renal Cell; Triple Negative Breast Neoplasms

Study Results

No Results Posted as of Jun 9, 2020