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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 : Active, not recruiting
First Posted : March 3, 2016
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation ( Incyte Biosciences International Sàrl )

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.

Condition or disease Intervention/treatment Phase
Advanced Malignancies Metastatic Cancer Drug: INCAGN01876 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN01876 in Subjects With Advanced or Metastatic Solid Tumors
Actual Study Start Date : April 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020


Arm Intervention/treatment
Experimental: INCAGN01876 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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02697591


Locations
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United States, California
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06511
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, New Jersey
Memorial Sloan Kettering at Monmouth
Middletown, New Jersey, United States, 07748
United States, New York
MSK Westchester
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Incyte Biosciences International Sàrl
Investigators
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Study Director: John Janik, MD Incyte Corporation

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Responsible Party: Incyte Biosciences International Sàrl
ClinicalTrials.gov Identifier: NCT02697591    
Other Study ID Numbers: INCAGN 1876-101
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Keywords provided by Incyte Corporation ( Incyte Biosciences International Sàrl ):
Solid tumor
adenocarcinoma of the endometrium
melanoma, non-small cell lung cancer (NSCLC)
renal cell carcinoma (RCC)
glucocorticoid-induced tumor necrosis factor receptor (GITR)
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes