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

Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03343613
• Other study ID #: 16786
• Secondary ID: I9L-MC-JZCA2017-
• Status: Terminated
• Phase: Phase 1
• Start date: November 17, 2017
• Est. completion date: May 4, 2020

Study information

• Verified date: June 2020
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: May 4, 2020
• Est. primary completion date: February 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Non Small Cell Lung Cancer
• Renal Cell Carcinoma
• Solid Tumor
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• LY3381916
IDO-1 inhibitor administered orally
• LY3300054
PD-L1 inhibitor administered IV

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet	Brussel
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	Universitair Ziekenhuis Gent	Gent
Denmark	Finsen Institute	Copenhagen
France	Gustave Roussy	Villejuif Cedex
Italy	Azienda Ospedaliera Umberto I	Ancona
Italy	Azienda Ospedaliera San Gerardo	Monza	Milano
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Clinico Universitario Virgen de la Victoria	Malaga	Andalucia
United States	IU Simon Cancer Center	Indianapolis	Indiana
United States	Sarah Cannon Research Institute SCRI	Nashville	Tennessee
United States	Tennessee Oncology PLLC	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Belgium,  Denmark,  France,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Dose Limiting Toxicities (DLTs)	Number of participants with DLTs	Baseline through Cycle 1 (28 Day Cycle)
Secondary	Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3381916	PK: Cmax of LY3381916	Predose Lead in Day 1 through Cycle 3 Day 1
Secondary	PK: Area Under the Plasma Concentration Curve (AUC) of LY3381916	PK: AUC of LY3381916	Predose Lead in Day 1 through Cycle 3 Day 1
Secondary	PK: Cmax of LY3381916 Administered in Combination with LY3300054	PK: Cmax of LY3381916 administered in combination with LY3300054	Predose Cycle 1 Day 1 through Cycle 3 Day 1
Secondary	PK: AUC of LY3381916 Administered in Combination with LY3300054	PK: AUC of LY3381916 administered in combination with LY3300054	Predose Cycle 1 Day 1 through Cycle 3 Day 1
Secondary	PK: Cmax of LY3300054 Administered in Combination with LY3381916	PK: Cmax of LY3300054 administered in combination with LY3381916	Predose Cycle 1 Day 1 through Cycle 3 Day 1
Secondary	PK: Minimum Plasma Concentration (Cmin) of LY3300054 Administered in Combination with LY3381916	PK: Cmin of LY3300054 administered in combination with LY3381916	Predose Cycle 1 Day 1 through Cycle 3 Day 1
Secondary	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	Baseline through Measured Progressive Disease (Estimated up to 12 Months)
Secondary	Time to Response (TTR)	TTR	Baseline to Date of CR or PR (Estimated up to 12 Months)
Secondary	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	Baseline through Measured Progressive Disease (Estimated up to 12 Months)
Secondary	Duration of Response (DOR)	DOR	Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)
Secondary	Progression Free Survival (PFS)	PFS	Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 12 Months)

External Links

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