Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors

  • STATUS
    Recruiting
  • days left to enroll
    69
  • participants needed
    140
  • sponsor
    Incyte Corporation
Send
Updated on 4 October 2022
See if I qualify

Summary

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors.

Details
Condition Advanced Solid Tumors, MSI-H/dMMR Tumors, Cutaneous Squamous Cell Carcinoma, Urothelial Carcinoma, HCC, Cervical Cancer, Esophageal Squamous Cell Carcinoma, Merkel Cell Carcinoma, Small-cell Lung Cancer, Mesothelioma, PD-L1 Amplified Tumor (9p24.1), Nasopharyngeal Carcinoma, Cyclin-dependent Kinase 12 Mutated Tumors, Basal Cell Carcinoma (Unresectable or Metastatic), Sarcomatoid Renal Cell Carcinoma, Clear Cell Ovarian or Endometrial Carcinoma, Anal Carcinoma, Squamous Cell Penile Carcinoma, DNA Polymerase Epsilon Mutated Tumors (P286R and V411L)
Treatment INCB099318
Clinical Study IdentifierNCT04272034
SponsorIncyte Corporation
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Must have disease progression after treatment with available therapies that are known to confer clinical benefit or must be intolerant to or ineligible for standard treatment
Histologically confirmed advanced solid tumors (protocol-defined select solid tumors) with measurable lesions per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) that are considered nonamenable to surgery or other curative treatments or procedures
ECOG performance status score of 0 or 1
Life expectancy > 12 weeks
Willingness to avoid pregnancy or fathering children

Exclusion Criteria

Exclusion Criteria
Laboratory values outside the Protocol-defined ranges
Clinically significant cardiac disease
History or presence of an ECG that, in the investigator's opinion, is clinically meaningful
Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases)
Known additional malignancy that is progressing or requires active treatment
Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy (including prior IO) and/or complications from prior surgical intervention before starting study treatment
Prior receipt of an anti-PD-L1 therapy
Treatment with anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug
A 28-day washout for systemic antibiotics is required
Probiotic usage while on study and during screening is prohibited
Active infection requiring systemic therapy
Known history of HIV
Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation
Clear my responses
Read more

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

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

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
Edit Delete

Added by • 

 • 

Private

Edit Delete

Reply by • • Private
Edit Delete

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.

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