Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies

  • STATUS
    Recruiting
Updated on 10 December 2020
cancer
measurable disease
pd-l1
metastatic cancer

Summary

The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies in subjects with advanced or metastatic malignancies.

 

Description

For more information, please contact Incyte Corporation at 1.855.463.3463

Details
Condition Metastatic Cancers, Advanced Malignancies
Clinical Study IdentifierTX216937
Last Modified on10 December 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent
Phase 1: Subjects with advanced or metastatic solid tumors
Phase 1: Subjects who have disease progression after treatment with available therapies
Phase 2: Subjects with advanced or metastatic cervical cancer, gastric cancer (including stomach, esophageal, and GEJ), SCCHN and PD-1/PD-L1 relapsed melanoma
Presence of measurable disease based on RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

Exclusion Criteria

Laboratory and medical history parameters not within the Protocol-defined range
Prior treatment with any tumor necrosis factor super family agonist
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
Active autoimmune disease
Known active central nervous system metastases and/or carcinomatous meningitis
Evidence of active, noninfectious pneumonitis or history of interstitial lung disease
Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation
Known history of human immunodeficiency virus (HIV; HIV 1/2 antibodies)
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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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