A Study Exploring the Safety and Tolerability of INCB081776 in Participants With Advanced Malignancies

Stopped early · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of single-agent INCB081776 (Part 1) and INCB081776 in combination with INCMGA00012 (Part 2).

Key facts

Study ID

NCT03522142

Run by

Incyte Corporation

People needed

83

Starts

2018-08-27

Expected to finish

2025-09-10

Last updated by the study team

2025-10-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female participants at least 18 years of age with advanced malignancies who have received or been intolerant to standard therapy:
• 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.

You may not qualify if…

• Laboratory values not within the protocol-defined range.
• 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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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