Clinical trial NCT03343613: A Study of LY3381916 Alone or in Combination With LY3300054 in Participants With Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Solid Tumor
Non Small Cell Lung Cancer
Renal Cell Carcinoma
Triple Negative Breast Cancer
Keywords: IDO-1 Inhibitor
IDO1 Inhibitor
IDO Inhibitor
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2017-11-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with Dose Limiting Toxicities (DLTs)
timeFrame: Baseline through Cycle 1 (28 Day Cycle)
Secondary outcomes:
measure: Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3381916
timeFrame: Predose Lead in Day 1 through Cycle 3 Day 1
measure: PK: Area Under the Plasma Concentration Curve (AUC) of LY3381916
timeFrame: Predose Lead in Day 1 through Cycle 3 Day 1
measure: PK: Cmax of LY3381916 Administered in Combination with LY3300054
timeFrame: Predose Cycle 1 Day 1 through Cycle 3 Day 1
measure: PK: AUC of LY3381916 Administered in Combination with LY3300054
timeFrame: Predose Cycle 1 Day 1 through Cycle 3 Day 1
measure: PK: Cmax of LY3300054 Administered in Combination with LY3381916
timeFrame: Predose Cycle 1 Day 1 through Cycle 3 Day 1
measure: PK: Minimum Plasma Concentration (Cmin) of LY3300054 Administered in Combination with LY3381916
timeFrame: Predose Cycle 1 Day 1 through Cycle 3 Day 1
measure: Objective Response Rate (ORR): Percentage of Participants with a Complete Response (CR) or Partial Response (PR)
timeFrame: Baseline through Measured Progressive Disease (Estimated up to 12 Months)
measure: Time to Response (TTR)
timeFrame: Baseline to Date of CR or PR (Estimated up to 12 Months)
measure: Disease Control Rate (DCR): Percentage of Participants who Exhibit Stable Disease (SD), CR or PR
timeFrame: Baseline through Measured Progressive Disease (Estimated up to 12 Months)
measure: Duration of Response (DOR)
timeFrame: Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)
measure: Progression Free Survival (PFS)
timeFrame: Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 12 Months)
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Simon Cancer Center
state: Indiana
city: Nashville
country: United States
facility: Sarah Cannon Research Institute SCRI
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology PLLC
state: Tennessee
city: Brussel
country: Belgium
facility: Institut Jules Bordet
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Copenhagen
country: Denmark
facility: Finsen Institute
city: Villejuif Cedex
country: France
facility: Gustave Roussy
city: Monza
country: Italy
facility: Azienda Ospedaliera San Gerardo
state: Milano
city: Ancona
country: Italy
facility: Azienda Ospedaliera Umberto I
city: Malaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria
state: Andalucia
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: