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A Phase 1/2, Open-Label, Dose-Escalation, Safety Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors

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ClinicalTrials.gov Identifier: NCT02923349
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation ( Incyte Biosciences International Sàrl )

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.

Condition or disease Intervention/treatment Phase
Advanced Malignancies Metastatic Cancer Drug: INCAGN01949 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 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 INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors
Actual Study Start Date : October 2016
Actual Primary Completion Date : March 26, 2019
Actual Study Completion Date : March 26, 2019


Arm Intervention/treatment
Experimental: INCAGN01949 Drug: INCAGN01949
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.




Primary Outcome Measures :
  1. Safety and tolerability will be assessed by monitoring frequency, duration, and severity of adverse events [ Time Frame: From screening through 60 days after end of treatment, up to 18 months. ]

Secondary Outcome Measures :
  1. Maximum observed concentration (Cmax) of INCAGN01949 in serum [ 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 INCAGN01949 [ Time Frame: Protocol-defined timepoints in treatment Cycles 1-7, up to 4 months ]
  3. Objective response rate per RECIST and modified RECIST [ Time Frame: 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 ]
    Defined as percentage of subjects having complete response or partial response

  4. Duration of response per RECIST and modified RECIST [ Time Frame: 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 ]
    Defined as the time from earliest date of disease response until earliest date of disease progression or death.

  5. Progression-free survival per RECIST and modified RECIST [ Time Frame: 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 ]
    Defined as the time from date of first dose of study drug until the earliest date of disease progression or death.

  6. Duration of disease control per RECIST and modified RECIST [ Time Frame: 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 ]
    Measured from first report of stable disease or better until disease progression or death.



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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.
  • 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.

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): NCT02923349


Locations
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United States, New Jersey
Rutgers, The State University of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, New York
New York University Clinical Cancer Center
New York, New York, United States, 10016
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Spain
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona, Spain, 08035
Switzerland
University Hospital of Laussane (CHUV)
Lausanne, Switzerland, 1011
United Kingdom
University College Hospital
London, United Kingdom, NW1 2PG
University of Oxford
Oxford, United Kingdom, OX3 7LE
Sponsors and Collaborators
Incyte Biosciences International Sàrl
Investigators
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Study Director: John E. Janik, MD Incyte Corporation

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Responsible Party: Incyte Biosciences International Sàrl
ClinicalTrials.gov Identifier: NCT02923349     History of Changes
Other Study ID Numbers: INCAGN 1949-101
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Keywords provided by Incyte Corporation ( Incyte Biosciences International Sàrl ):
Solid tumor
adenocarcinoma of the endometrium
ovarian cancer
renal cell carcinoma
melanoma
non-small cell lung cancer
OX40
immunoglobulin G monoclonal antibody
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes