A Phase 1/2, Open-Label, Dose-Escalation, Safety Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors
NCT ID: NCT02923349
Last Updated: 2025-08-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
87 participants
INTERVENTIONAL
2016-10-31
2019-03-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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INCAGN01949
INCAGN01949
Initial cohort dose of INCAGN01949 monotherapy at the protocol-defined starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose will be taken forward into expansion cohorts.
Interventions
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INCAGN01949
Initial cohort dose of INCAGN01949 monotherapy at the protocol-defined starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose will be taken forward into expansion cohorts.
Eligibility Criteria
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Inclusion Criteria
* Subjects who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or who refuse standard treatment. There is no limit to the number of prior treatment regimens.
* Part 1: Subjects with advanced or metastatic solid tumors.
* Part 2: Subjects with advanced or metastatic adenocarcinoma of the endometrium, ovarian cancer, renal cell carcinoma, melanoma, and non-small cell lung cancer.
* Presence of measureable disease based on RECIST v1.1.
* Eastern Cooperative Oncology Group performance status 0 or 1.
Exclusion Criteria
* Receipt of anticancer medications or investigational drugs within the protocol-defined intervals before the first administration of study drug.
* Has not recovered to ≤ Grade 1 from toxic effects of prior therapy (including prior immunotherapy) and/or complications from prior surgical intervention before starting therapy.
* Receipt of a live vaccine within 30 days of planned start of study drug.
* Active autoimmune disease that required systemic treatment in the past.
18 Years
ALL
No
Sponsors
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Incyte Biosciences International Sàrl
INDUSTRY
Responsible Party
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Principal Investigators
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John E. Janik, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Rutgers, The State University of New Jersey
New Brunswick, New Jersey, United States
New York University Clinical Cancer Center
New York, New York, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona, , Spain
University Hospital of Laussane (CHUV)
Lausanne, , Switzerland
University College Hospital
London, , United Kingdom
University of Oxford
Oxford, , United Kingdom
Countries
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References
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Davis EJ, Martin-Liberal J, Kristeleit R, Cho DC, Blagden SP, Berthold D, Cardin DB, Vieito M, Miller RE, Hari Dass P, Orcurto A, Spencer K, Janik JE, Clark J, Condamine T, Pulini J, Chen X, Mehnert JM. First-in-human phase I/II, open-label study of the anti-OX40 agonist INCAGN01949 in patients with advanced solid tumors. J Immunother Cancer. 2022 Oct;10(10):e004235. doi: 10.1136/jitc-2021-004235.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-002079-93
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INCAGN 1949-101
Identifier Type: -
Identifier Source: org_study_id
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