Epacadostat + Sirolimus for Advanced Cancers

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byChao Huang, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Chao Huang

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a small phase I study with dose escalation and dose expansion cohorts. The former cohort will need up to 12 subjects with advanced solid tumor to define feasibility and recommended phase 2 dose (RP2D); the latter up to 10 subjects to further define safety. Study subjects will be adults with advanced solid tumor (dose escalation) and advanced non-small cell lung cancer (NSCLC) who progressed on at least one first-line systemic therapy (dose expansion).

Eligibility Criteria

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.

Inclusion Criteria

No known allergy or reaction to any component of either study drug formulation

Not pregnant or nursing

I haven't taken MAOI drugs in the last 21 days.

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Exclusion 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.

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Treatment Details

Interventions

Epacadostat (IDO1 Inhibitor)
Sirolimus (mTOR Inhibitor)

Trial OverviewThe 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.

Participant Groups

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.

Epacadostat is already approved in United States for the following indications:

🇺🇸 Approved in United States as Epacadostat for: