A Phase 1/2, Open-Label, Dose-Escalation, Safety Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors
2 other identifiers
interventional
87
4 countries
8
Brief Summary
The purpose of this study is to determine the safety and tolerability and assess preliminary efficacy of INCAGN01949 in subjects with advanced or metastatic solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2016
Typical duration for phase_1
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2016
CompletedFirst Posted
Study publicly available on registry
October 4, 2016
CompletedStudy Start
First participant enrolled
October 31, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2019
CompletedResults Posted
Study results publicly available
May 12, 2020
CompletedAugust 24, 2025
August 1, 2025
2.4 years
October 3, 2016
March 26, 2020
August 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment-related Adverse Events
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
From screening through 60 days after end of treatment, up to 11 months
Secondary Outcomes (8)
Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma
Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949
Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
Objective Response Rate Per RECIST and Modified RECIST
Baseline and every 8 weeks,up to 11 months
Duration of Response Per RECIST and Modified RECIST
Baseline and every 8 weeks, up to 11 months
Progression-free Survival Per RECIST and Modified RECIST
Baseline and every 8 weeks, up to 11 months
- +3 more secondary outcomes
Study Arms (1)
INCAGN01949
EXPERIMENTALInterventions
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
You may qualify if:
- Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
- 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.
You may not qualify if:
- Laboratory and medical history parameters not within the protocol-defined range.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Rutgers, The State University of New Jersey
New Brunswick, New Jersey, 08901, United States
New York University Clinical Cancer Center
New York, New York, 10016, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona, 08035, Spain
University Hospital of Laussane (CHUV)
Lausanne, 1011, Switzerland
University College Hospital
London, NW1 2PG, United Kingdom
University of Oxford
Oxford, OX3 7LE, United Kingdom
Related Publications (1)
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.
PMID: 36316061DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Incyte Biosciences International Sàrl
- Organization
- Incyte Corporation Call Centre
Study Officials
- STUDY DIRECTOR
John E. Janik, MD
Incyte Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2016
First Posted
October 4, 2016
Study Start
October 31, 2016
Primary Completion
March 26, 2019
Study Completion
March 26, 2019
Last Updated
August 24, 2025
Results First Posted
May 12, 2020
Record last verified: 2025-08