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

  • STATUS
    Recruiting
  • End date
    Sep 27, 2022
  • participants needed
    140
  • sponsor
    Incyte Corporation
Updated on 7 October 2021

Summary

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).

Details
Condition Advanced Solid Tumors
Treatment Nivolumab, INCMGA00012, INCB081776
Clinical Study IdentifierNCT03522142
SponsorIncyte Corporation
Last Modified on7 October 2021

Eligibility

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 nave 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 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)
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.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

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

Learn more

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.

Learn more

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

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note