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IDO1 Inhibitor
Epacadostat + Sirolimus for Advanced Cancers
Phase 1
Waitlist Available
Led By Chao Huang, MD
Research Sponsored by Chao Huang
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status #0-2
No prior ≥ Grade 3 immune-related adverse event (irAE) while receiving immunotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see if it is safe and effective. So far, it has only been tested on a small number of people.
Who is the study for?
Adults with advanced solid tumors, specifically those with non-small cell lung cancer (NSCLC) that has worsened after first-line treatment. Participants must be over 18, have adequate organ function, and not have any health issues or treatments that could affect the study's results. They should not be pregnant or nursing and must agree to use contraception.Check my eligibility
What is being tested?
The trial is testing Epacadostat in combination with Sirolimus on patients with advanced malignancies. It includes a dose escalation phase to determine safe dosage levels followed by a dose expansion phase to further assess safety for NSCLC patients who've had prior therapy.See study design
What are the potential side effects?
Potential side effects may include immune system reactions affecting various organs, infusion-related responses, fatigue, digestive disturbances, blood disorders, increased risk of infections and specific organ inflammation such as pneumonitis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself and perform daily activities.
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I have never had a severe reaction to immunotherapy.
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I am not using, nor do I plan to use, drugs that affect CYP3A4 enzyme activity.
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I am not taking any UGT1A9 inhibitor medication.
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I have never had lung scarring or inflammation not caused by infections.
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I have not had any eye problems due to immune-related side effects.
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I have received at least one round of systemic therapy.
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I am 18 years old or older.
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I do not have active hepatitis B or C.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of treatment-emergent adverse events.
Secondary outcome measures
Disease control rate (DCR) >40% in subjects with NSCLC (dose expansion cohort)
Median Overall Survival (mOS) > 6 months in subjects with NSCLC (dose expansion cohort)
Median progression free survival (mPFS) >3 months in subjects with NSCLC (dose expansion cohort)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Sirolimus/Epacadostat Dose ExpansionExperimental Treatment2 Interventions
Once recommended phase 2 dose (RP2D) is defined, a total of 10 non-small cell lung cancer (NSCLC) patients who meet eligibility will be enrolled in the dose expansion cohort. Treatment will be sirolimus RP2D once daily and epacadostat RP2D twice daily (BID).
Sirolimus lead-in phase: loading dose on day -7 and maintenance dose starting day -6. On Cycle 1 Day 1, epacadostat 300mg BID will be added.
Group II: Sirolimus/Epacadostat Dose EscalationExperimental Treatment2 Interventions
Traditional 3 + 3 dose escalation design.
Starting doses: sirolimus 3milligrams (mg) loading/1mg maintenance and epacadostat 300mg twice daily (BID). If 0 in 3 subjects develops dose limiting toxicity (DLT), next 3 subjects will be treated at dose level 2 (DL2): sirolimus 6mg loading/2mg maintenance and epacadostat 300mg BID. If 1 subject in dose level 1 (DL1) develops DLT, 3 additional subjects will be enrolled in DL1. If 2 or more subjects in a total of 6 subjects, or 2 or more subjects in the initial 3 subjects develop DLT, the next 3 subjects will be treated at dose level -1 (DL-1): 3mg loading/1mg sirolimus + epacadostat 100mg BID. If only 1 subject in a total of 6 develops DLT, dose escalation to DL2 will be made for the next 3 subjects. Same algorithm will apply to DL2 except no further dose escalation/de-escalation will be made.
Sirolimus lead-in phase: loading dose on day -7 and maintenance dose starting day -6. On Cycle 1 Day 1, epacadostat 300mg BID will be added.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Epacadostat
2018
Completed Phase 3
~1080
sirolimus
2006
Completed Phase 4
~1510
Find a Location
Who is running the clinical trial?
Chao HuangLead Sponsor
University of Kansas Medical CenterOTHER
469 Previous Clinical Trials
171,317 Total Patients Enrolled
Chao Huang, MDPrincipal Investigator - KUMC
Jayhawk Primary Care Inc, Kansas City VA Medical Center
University Fed De Rio Grande Do Sul (Medical School)
Temple University Hospital (Residency)
3 Previous Clinical Trials
58 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with an IDO inhibitor.I have been treated with drugs targeting PI3K, AKT, or mTOR for my cancer.You have had or currently have an abnormal ECG that the doctor thinks is important.I haven't taken MAOI drugs in the last 21 days.I am not taking any UGT1A9 inhibitor medication.I had a severe reaction to previous immunotherapy.I have not taken high-dose steroids or immunosuppressants in the last 14 days.I am not taking any UGT1A9 inhibitor medications.I am able to care for myself and perform daily activities.My organs and bone marrow are working well.I have never had a severe reaction to immunotherapy.I am not receiving treatment for an autoimmune or inflammatory disease.I do not have any untreated or uncontrolled illnesses.I am not using, nor do I plan to use, drugs that affect CYP3A4 enzyme activity.I have had a condition where lymphocytes grow abnormally.I haven't had chemotherapy in the last 3 weeks or still have side effects from earlier treatments.I had radiotherapy less than 2 weeks ago.I can tolerate treatments that may affect my liver.I haven't had monoclonal antibody treatment in the last 4 weeks or still have side effects from treatments over 4 weeks ago.I agree to use birth control during the study.I have a history of cancer.I don't have any health issues that could affect the study's results.I have never had lung scarring or inflammation not caused by infections.I have not had any eye problems due to immune-related side effects.I haven't taken MAOI drugs or similar in the last 21 days.I have received at least one round of systemic therapy.I am using or might need drugs that affect liver enzyme CYP3A4.My brain cancer causes symptoms, is getting worse, or needs steroids.I don't have any health issues that could affect the study's results.I do not have any unmanaged ongoing illnesses.I am 18 years old or older.I do not have active hepatitis B or C.I haven't had cancer in the last 5 years, except for skin cancer.I have an autoimmune disease but am not on systemic therapy, with some exceptions.
Research Study Groups:
This trial has the following groups:- Group 1: Sirolimus/Epacadostat Dose Escalation
- Group 2: Sirolimus/Epacadostat Dose Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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