Clinical trial NCT02697591: A Study of INCAGN01876 in Participants With Advanced or Metastatic Solid Tumors
Official title: A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN01876 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
melanoma, non-small cell lung cancer (NSCLC)
renal cell carcinoma (RCC)
glucocorticoid-induced tumor necrosis factor receptor (GITR)
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2016-03-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This was an open-label, non-randomized Phase 1/2 safety study of INCAGN01876 in participants with advanced or metastatic solid tumors that was conducted in 2 parts. Part 1 is dose escalation and safety expansion which determines the optimal dose and maximum number of tolerated doses. Part 2 is dose expansion in which Part 1 recommended dose will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
* Part 1: Participants with advanced or metastatic solid tumors.
* Part 2: Participants with advanced or metastatic adenocarcinoma of endometrium, melanoma, non-small cell lung cancer, and renal cell carcinoma.
* Participants who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or participants who refuse standard treatment.
* Presence of measurable disease based on Response Evaluation Criteria in Solid Tumors (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.
* 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.
* Prior treatment with any tumor necrosis factor super family agonist.
* Known active central nervous system metastases and/or carcinomatous meningitis.
* Evidence of active, non-infectious pneumonitis or history of interstitial lung disease.
* Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.

Primary outcomes:
measure: Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) and as Per the Severity
timeFrame: From screening through 60 days after end of treatment, up to Month 15
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Day 1 of Cycles 1 and 6 post-dose
measure: Time to Maximum Concentration (Tmax)
timeFrame: Day 1 of Cycles 1 and 6 post-dose
measure: Minimum Observed Plasma Concentration Over the Dose Interval (Cmin)
timeFrame: Day 1 of Cycles 2, 3, 4, 6, and 7 post-dose
measure: Area Under the Plasma Time Curve From Time = 0 to the Last Measurable Concentration (AUC0-t)
timeFrame: Day 1 of Cycles 1 and 6 post-dose
measure: Objective Response Rate (ORR) Per RECIST v1.1 and Modified RECISTv1.1 (mRECIST)
timeFrame: Baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter up to 15 months
measure: Duration of Response (DOR) Per RECIST and mRECIST
timeFrame: Baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter up to 15 months
measure: Duration of Disease Control Per RECIST and mRECIST
timeFrame: Baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter up to 15 months
measure: Progression Free Survival (PFS) Per RECIST and mRECIST
timeFrame: Baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter up to 15 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institute
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Middletown
country: United States
facility: Memorial Sloan Kettering at Monmouth
state: New Jersey
city: Harrison
country: United States
facility: MSK Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Incyte Corporation
name: John Janik, MD
role: STUDY_DIRECTOR
References: