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INCB081776 + INCMGA00012 for Cancer

Phase 1
Waitlist Available
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female participants at least 18 years of age with advanced malignancies who have received or been intolerant to standard therapy
Cohorts 1-3 must have received 1 prior PD-1/L1 treatment and have experienced PD during or after that treatment and have progressed on other SOC therapy(ies); Cohort 4 must be PD-1/L1 treatment naïve but have progressed on SOC therapy(ies)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 1 year.
Awards & highlights

Study Summary

This trial is testing a new cancer drug and its potential side effects.

Who is the study for?
This trial is for adults with advanced malignancies, including melanoma, lung cancer (NSCLC), head and neck cancer (SCCHN), soft-tissue sarcoma, and others. Participants must have measurable disease and may have received prior treatments as specified per cohort. They should be willing to undergo tumor biopsies but cannot join if they have significant heart issues, active autoimmune diseases requiring recent treatment, certain infections like hepatitis or HIV, or haven't recovered from previous therapy side effects.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of INCB081776 alone (Part 1) and combined with INCMGA00012 (Part 2). It will assess how these drugs are processed in the body and their impact on tumors. The trial aims to find out if these interventions can help treat various types of advanced cancers by monitoring early clinical activity.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones for cancer treatments like INCB081776 and INCMGA00012 might include fatigue, nausea, inflammation-related symptoms due to immune system activation, potential organ-specific toxicity such as liver or kidney issues, skin reactions at injection sites among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 or older with advanced cancer and have tried or can't tolerate standard treatments.
Select...
I have had one PD-1/L1 treatment and my cancer got worse, or I haven't had PD-1/L1 treatment but my cancer progressed after standard treatments.
Select...
My cancer type matches one of the specified groups for the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1 (1A and 1B): Number of treatment-emergent adverse events (TEAEs)
Part 1 (1A and 1B): Recommended Dose for Expansion (RDE)
Part 2 (2A & 2B): Number of treatment-emergent adverse events
+1 more
Secondary outcome measures
Part 1 and Part 2 : CL/F of INCB081776
Part 1 and Part 2 : Vz/F of INCB081776
Part 1 and Part 2 : λz of INCB081776
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: INCB081776 + INCMGA00012Experimental Treatment2 Interventions
INCB081776 in combination with INCMGA00012.
Group II: INCB081776Experimental Treatment1 Intervention
Single-agent INCB081776.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INCMGA00012
2021
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
361 Previous Clinical Trials
54,966 Total Patients Enrolled
Diane Hershock, MDStudy DirectorIncyte Corporation
1 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

INCB081776 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03522142 — Phase 1
Solid Tumors Research Study Groups: INCB081776, INCB081776 + INCMGA00012
Solid Tumors Clinical Trial 2023: INCB081776 Highlights & Side Effects. Trial Name: NCT03522142 — Phase 1
INCB081776 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03522142 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current sample size of this experiment?

"This medical trial necessitates the participation of 140 qualified patients, who can attend one of two locations: Dana Farber Cancer Institute in Hackensack, New jersey or at Hackensack University Medical Center in Houston, Texas."

Answered by AI

Is there any precedent for the utilization of INCB081776 in scientific research?

"Presently, 26 medical trials are being conducted to explore the effects of INCB081776. Three of these live studies have reached Phase 3. Although most investigations regarding this medication take place in A CORU�A and Virginia, there are 810 sites conducting research on its efficacy."

Answered by AI

Is this a revolutionary clinical trial?

"Research on INCB081776 has been conducted since 2016, when Incyte Corporation sponsored the first trial with 325 participants. Following successful completion of this phase 1 study, it was approved for use in clinical settings and today 26 trials are active across 117 cities and 43 nations."

Answered by AI

Has the drug INCB081776 been given regulatory authorization by the FDA?

"With limited evidence of INCB081776's safety and efficacy, our team at Power has assigned a score of 1 to this medication."

Answered by AI

What is the ultimate goal of this clinical research?

"According to the Incyte Corporation, which sponsors this trial, the primary objective is measuring treatment-emergent adverse events (TEAEs) over a Screening through 90 days after end of treatment period. Secondary objectives include examining Cmax, t½ and Vz/F for INCB081776."

Answered by AI

In what locations is this clinical study taking place?

"This medical trial is being conducted at multiple locations, including the Dana Farber Cancer Institute in Hackensack, New jersey; Hackensack University Medical Center in Houston, Texas; and Md Anderson Cancer Centre in Madison Wisconsin. In addition to these three sites, there are an additional 9 participating clinics."

Answered by AI

Is this trial available to participants at the present moment?

"Clinicaltrials.gov indicates that this trial is actively recruiting, having been first posted on August 27th 2018 and updated most recently on November 10th 2022."

Answered by AI
~9 spots leftby Nov 2024