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

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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 Identifier	TX149864
Sponsor	Incyte Europe Sàrl
Last Modified on	8 December 2020

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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

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Step 4 Get your study results

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