Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Open-Label, Dose-Escalation, Safety Study of INCAGN01876 in Subjects With Advanced or Metastatic Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02697591
Recruitment Status : Completed
First Posted : March 3, 2016
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation ( Incyte Biosciences International Sàrl )

Tracking Information
First Submitted Date  ICMJE February 22, 2016
First Posted Date  ICMJE March 3, 2016
Last Update Posted Date April 15, 2020
Actual Study Start Date  ICMJE April 30, 2016
Actual Primary Completion Date December 16, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2016)
Safety and tolerability will be assessed by monitoring frequency, duration, and severity of adverse events (AEs) [ Time Frame: AEs assessed from screening through 60 days after end of treatment, up to 18 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2018)
  • Maximum observed concentration (Cmax) of INCAGN01876 in serum will be summarized [ Time Frame: Protocol-defined timepoints in treatment Cycles 1-7, up to 4 months ]
  • Area under the single-dose concentration-time curve (AUC0-t) of INCAGN01876 will be summarized [ Time Frame: Protocol-defined timepoints in treatment Cycles 1-7, up to 4 months ]
  • Objective response rate (ORR) per RECIST and modified RECIST (mRECIST) [ Time Frame: Preliminary efficacy at baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter for duration of study participation, up to 18 months ]
  • Duration of response per RECIST and modified RECIST (mRECIST) [ Time Frame: Preliminary efficacy at baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter for duration of study participation, up to 18 months ]
  • Duration of disease control per RECIST and modified RECIST (mRECIST) [ Time Frame: Preliminary efficacy at baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter for duration of study participation, up to 18 months ]
  • Progression free survival (PFS) per RECIST and modified RECIST (mRECIST) [ Time Frame: Preliminary efficacy at baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter for duration of study participation, up to 18 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2016)
  • Maximum observed concentration (Cmax) of INCAGN01876 in serum will be summarized [ Time Frame: Protocol-defined timepoints in treatment Cycles 1-7, up to 4 months ]
  • Area under the single-dose concentration-time curve (AUC0-t) of INCAGN01876 will be summarized [ Time Frame: Protocol-defined timepoints in treatment Cycles 1-7, up to 4 months ]
  • Objective response rate (ORR) per RECIST and modified RECIST (mRECIST) [ Time Frame: Preliminary efficacy at baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter for duration of study participation, up to 18 months ]
  • Duration of response per RECIST and modified RECIST (mRECIST) [ Time Frame: Preliminary efficacy at baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter for duration of study participation, up to 18 months ]
  • Rate of disease control per RECIST and modified RECIST (mRECIST) [ Time Frame: Preliminary efficacy at baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter for duration of study participation, up to 18 months ]
  • Progression free survival (PFS) per RECIST and modified RECIST (mRECIST) [ Time Frame: Preliminary efficacy at baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter for duration of study participation, up to 18 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-Label, Dose-Escalation, Safety Study of INCAGN01876 in Subjects With Advanced or Metastatic Solid Tumors
Official Title  ICMJE A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN01876 in Subjects With Advanced or Metastatic Solid Tumors
Brief Summary This is an open-label, non-randomized Phase 1/2 safety study of INCAGN01876 in subjects with advanced or metastatic solid tumors that will be conducted in 2 parts. Part 1 will determine the pharmacologically active dose and/or maximum tolerated dose of INCAGN01876. Part 2 will further evaluate the recommended dose determined in Part 1 in subjects with select tumor types.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Malignancies
  • Metastatic Cancer
Intervention  ICMJE Drug: INCAGN01876
Initial cohort dose of INCAGN01876 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.
Study Arms  ICMJE Experimental: INCAGN01876
Intervention: Drug: INCAGN01876
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 12, 2019)
100
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2016)
146
Actual Study Completion Date  ICMJE December 16, 2019
Actual Primary Completion Date December 16, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent
  • Part 1: Subjects with advanced or metastatic solid tumors
  • Part 2: Subjects with advanced or metastatic adenocarcinoma of endometrium, melanoma, non-small cell lung cancer, and renal cell carcinoma
  • Subjects who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or subjects who refuse standard treatment
  • Presence of measureable 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
  • 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, noninfectious pneumonitis or history of interstitial lung disease
  • Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02697591
Other Study ID Numbers  ICMJE INCAGN 1876-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Incyte Corporation ( Incyte Biosciences International Sàrl )
Study Sponsor  ICMJE Incyte Biosciences International Sàrl
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: John Janik, MD Incyte Corporation
PRS Account Incyte Corporation
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP