A Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Malignancies
NCT ID: NCT03522142
Last Updated: 2025-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
83 participants
INTERVENTIONAL
2018-08-27
2025-09-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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INCB081776
Single-agent INCB081776.
INCB081776
INCB081776 administered once or twice daily orally with water after a fast of at least 2 hours before and at least 1 hour after the dose.
INCB081776 + INCMGA00012
INCB081776 in combination with INCMGA00012.
INCB081776
INCB081776 administered once or twice daily orally with water after a fast of at least 2 hours before and at least 1 hour after the dose.
INCMGA00012
INCMGA0012 administered intravenously according to the label as 500 mg every 4 weeks
Interventions
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INCB081776
INCB081776 administered once or twice daily orally with water after a fast of at least 2 hours before and at least 1 hour after the dose.
INCMGA00012
INCMGA0012 administered intravenously according to the label as 500 mg every 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Parts 1A and 2A:
* Histologically confirmed advanced or metastatic gastric or GEJ adenocarcinoma, HCC, melanoma, NSCLC, RCC, soft-tissue sarcoma, SCCHN (recurrent or metastatic), TNBC, or urothelial carcinoma. Additional tumor histologies, including MSI-H tumors, may be allowed with approval from the medical monitor.
* Measurable disease per RECIST v1.1.
Parts 1B and 2B:
• Histologic confirmation of the cohort-specific tumor types specified below: Cohort 1 - Advanced or metastatic melanoma Cohort 2 - Advanced or metastatic NSCLC Cohort 3 - Recurrent or metastatic SCCHN Cohort 4 - Advanced or metastatic soft-tissue sarcoma
* 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).
* Measurable disease per RECIST v1.1.
* Must be willing to submit to a fresh baseline tumor biopsy and an on-treatment biopsy between Cycle 2 Day 1 and Cycle 3 Day 1.
* Care should be taken to biopsy the same lesion for the baseline and on-treatment samples. If a participant has a solitary target lesion, this should not be biopsied.
Part 1C:
* Participants with relapsed/refractory AML following standard therapy; acute promyelocytic leukemia (M3) and therapy-related AML are excluded.
* FLT3-ITD and IDH1/2 wild-type or mutated are eligible; appropriate targeted therapy for participants with actionable mutations must have been received.
Exclusion Criteria
* History of retinal disease as defined in the protocol.
* Clinically significant cardiac disease as per protocol-defined criteria.
* History or presence of an ECG that, in the investigator's opinion, is clinically meaningful as per protocol-defined criteria.
* Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed as per protocol-defined criteria.
* Active or inactive autoimmune disease or syndrome that has required systemic treatment in the past 2 years or receiving systemic therapy for an autoimmune or inflammatory disease.
* Prior Grade 3 or higher immune-related AEs or any ocular toxicity on prior immunotherapy as per protocol-defined criteria.
* Receipt of any vitamin K antagonists, systemic corticosteroids, live vaccines, or treatment with any anticancer medications or investigational drugs within the protocol-defined intervals.
* Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy and/or complications from prior surgical intervention before starting study treatment.
* Active infection requiring systemic therapy.
* Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
* Known history of HIV (HIV 1/2 antibodies).
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Diane Hershock, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Yale Cancer Center
New Haven, Connecticut, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Md Anderson Cancer Center
Houston, Texas, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Rigshospitalet Uni of Hospital of Copenhagen
Copenhagen, , Denmark
Odense University Hospital
Odense C, , Denmark
Netherlands Cancer Institute Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
Haukeland University Hospital
Bergen, , Norway
Utprøvingsenheten, Oslo University Hospital Radiumhospitalet
Oslo, , Norway
Skane University Hospital Lund
Lund, , Sweden
Karolinska University Hospital Solna
Stockholm, , Sweden
Countries
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Other Identifiers
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2023-504499-29-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-004867-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCB 81776-101
Identifier Type: -
Identifier Source: org_study_id
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