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

  • End date
    Nov 28, 2023
  • participants needed
  • sponsor
    Incyte Corporation
Updated on 7 October 2022


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).

Condition Advanced Solid Tumors
Treatment INCMGA00012, INCB081776
Clinical Study IdentifierNCT03522142
SponsorIncyte Corporation
Last Modified on7 October 2022


Yes No Not Sure

Inclusion Criteria

• 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

Exclusion Criteria

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
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)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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