An Open-Label, Dose-Escalation, Safety Tolerability Study of INCAGN01876 in Subjects With Advanced or Metastatic Solid Tumors

  • STATUS
    Recruiting
  • sponsor
    Incyte Europe Sàrl
Updated on 8 December 2020
solid tumors
solid tumor
advanced solid tumor

Summary

An Open-Label, Dose-Escalation, Safety Tolerability Study of INCAGN01876 in Subjects With Advanced or Metastatic Solid Tumors

Description

This purpose of this study is to explore the safety of INCAGN01876 in subjects with advanced or metastatic solid tumors. The study has 2 parts: Part 1 will determine the recommended dose of INCAGN01876, while Part 2 will further evaluate the recommended dose in subjects with certain tumor types (endometrial cancer, melanoma, non-small cell lung cancer, and renal cell carcinoma).

For more information, please contact Incyte Corporation (responsible party for Incyte Europe Sàrl) at +1 (855) 463-3463.

Details
Condition All Solid Tumors, Solid Tumors
Clinical Study IdentifierTX149864
SponsorIncyte Europe Sàrl
Last Modified on8 December 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 0 yrs?
Gender: Male or Female
Do you have Solid Tumors?
Locally advanced or metastatic disease that must not be amenable to resection with curative intent
Part 1 subjects who have advanced or metastatic solid tumors, Part 2 subjects who have advanced or metastatic endometrial cancer, melanoma, non-small cell lung cancer, or renal cell carcinoma
Disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or subjects who refuse standard treatment
Measurable disease based on current treatment response criteria (RECIST v1.1)
Daily performance status of 0 to 1 based on the Eastern Cooperative Oncology Group (ECOG) ratings

Exclusion Criteria

Laboratory and medical history parameters not within the protocol-defined range
Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug
Has not recovered to ≤ Grade 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting therapy
Receipt of a live vaccine within 30 days of planned start of study therapy
Active autoimmune disease that required systemic treatment in the past 2 years
Clear my responses

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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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