Clinical trial NCT02923349: A Phase 1/2, Open-Label, Dose-Escalation, Safety Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors
Official title: A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Advanced Malignancies
Metastatic Cancer
Keywords: Solid tumor
adenocarcinoma of the endometrium
ovarian cancer
renal cell carcinoma
melanoma
non-small cell lung cancer
OX40
immunoglobulin G monoclonal antibody
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2016-10-04
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Participants With Treatment-related Adverse Events
timeFrame: From screening through 60 days after end of treatment, up to 11 months
Secondary outcomes:
measure: Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma
timeFrame: 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
measure: Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949
timeFrame: 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
measure: Objective Response Rate Per RECIST and Modified RECIST
timeFrame: Baseline and every 8 weeks,up to 11 months
measure: Duration of Response Per RECIST and Modified RECIST
timeFrame: Baseline and every 8 weeks, up to 11 months
measure: Progression-free Survival Per RECIST and Modified RECIST
timeFrame: Baseline and every 8 weeks, up to 11 months
measure: Duration of Disease Control Per RECIST and Modified RECIST
timeFrame: Baseline and every 8 weeks, up to 11 months
measure: Time to Maximum Concentration of INCAGN01949 in Plasma
timeFrame: 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
measure: Summary of Trough Concentrations(Cmin) of INCAGN01949
timeFrame: 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
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers, The State University of New Jersey
state: New Jersey
city: New York
country: United States
facility: New York University Clinical Cancer Center
state: New York
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Barcelona
country: Spain
facility: Vall d'Hebron Institute of Oncology (VHIO)
city: Lausanne
country: Switzerland
facility: University Hospital of Laussane (CHUV)
city: London
country: United Kingdom
facility: University College Hospital
city: Oxford
country: United Kingdom
facility: University of Oxford
Study officials:
affiliation: Incyte Corporation
name: John E. Janik, MD
role: STUDY_DIRECTOR
References:
citation: 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.