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A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT03059823
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
The primary goal of this Phase 1 study is to characterize the safety and tolerability of INCMGA00012 and establish the maximum tolerated dose (MTD) of INCMGA00012 administered on either every two week or every four week schedules of administration among patients with solid tumors. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of INCMGA00012 will also be assessed.

Condition or disease Intervention/treatment Phase
Locally Advanced Solid Tumors Metastatic Solid Tumors Drug: INCMGA00012 Phase 1

Detailed Description:

This is an open-label, multi-center, Phase 1 dose-escalation and dose expansion study to define a MTD, describe preliminary safety, and to assess PK, immunogenicity, and potential anti-tumor activity of INCMGA00012 administered on either every two week or every four week schedules in patients with relapsed/ refractory or unresectable locally/ advanced or metastatic solid tumors.

In the initial phase of the study, two dose schedules will be assessed in dose escalation, once every two weeks and once every four weeks administration of single agent INCMGA00012. Following the establishment of an MTD, additional patients will enroll in expansion cohorts of specific tumor types and/or INCMGA00012 dose.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 207 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of INCMGA00012 in Patients With Advanced Solid Tumors
Actual Study Start Date : November 2016
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
Experimental: Dose Escalation-Q2W
INCMGA00012 treatment once every 2 weeks
Drug: INCMGA00012
Anti-PD-1 monoclonal antibody

Experimental: Dose Escalation- Q4W
INCMGA00012 treatment once every 4 weeks
Drug: INCMGA00012
Anti-PD-1 monoclonal antibody

Experimental: Expansion Cohort
INCMGA00012 treatment for locally advanced or metastatic solid tumors
Drug: INCMGA00012
Anti-PD-1 monoclonal antibody




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.03 [ Time Frame: 24 months ]
    Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.

  2. MTD [ Time Frame: 24 months ]
    Maximum Tolerated Dose of INCMGA00012


Secondary Outcome Measures :
  1. AUC [ Time Frame: 24 months ]
    Area Under the Plasma Concentration versus Time Curve of INCMGA00012

  2. Cmax [ Time Frame: 24 months ]
    Maximum Plasma Concentration of INCMGA00012

  3. Tmax [ Time Frame: 24 months ]
    Time to reach maximum (peak) plasma concentration of INCMGA00012

  4. Ctrough [ Time Frame: 24 months ]
    Trough plasma concentration of INCMGA00012

  5. Total body clearance of the drug from plasma (CL) of INCMGA00012 [ Time Frame: 24 months ]
  6. Vss [ Time Frame: 24 months ]
    Apparent volume of distribution at steady state of INCMGA00012

  7. t1/2 [ Time Frame: 24 months ]
    Terminal half-life of INCMGA00012

  8. ADA [ Time Frame: 24 months ]
    Percent of patients with anti-drug antibody



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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:

  • Histologically proven, locally advanced unresectable or metastatic solid tumors for whom no approved therapy with demonstrated clinical benefit is available or standard treatment was declined.
  • Expansion cohort(s): Progression during or following at least 1, and up to 5, previous systemic therapies, consistent with the standard of care for the specific tumor type.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy ≥ 12 weeks
  • Measurable disease
  • Acceptable laboratory parameters

Exclusion Criteria:

  • Symptomatic central nervous system (CNS) metastases.
  • For Cohort Expansion, patients who have previously received an immune checkpoint inhibitor (e.g., anti-PD-L1, anti-PD-1, anti-CTLA-4) are not eligible for this study.
  • Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, resolved childhood atopic dermatitis, psoriasis not requiring systemic treatment (within the past 2 years), and patients with a history of Grave's disease that are now euthyroid clinically and by laboratory testing.
  • Treatment with any systemic anti-neoplastic therapy, or investigational therapy within the 4 weeks prior to the initiation of study drug administration.
  • Treatment with radiation therapy within 2 weeks prior to the initiation of study drug administration.
  • Clinically significant cardiovascular disease
  • Clinically significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation.
  • Presence of active pneumonitis or history of non-infectious pneumonitis.
  • Clinically significant gastrointestinal disorders
  • Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug. Patients requiring any systemic antiviral, antifungal, or antibacterial therapy for active infection must have completed treatment no less than one week prior to the initiation of study drug
  • Known history of positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.
  • Known history of hepatitis B or hepatitis C infection or known positive test for hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C polymerase chain reaction (PCR)
  • Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed
  • Dementia or altered mental status that would preclude understanding and rendering of informed consent

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): NCT03059823


Contacts
Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 globalmedinfo@incyte.com

  Show 29 Study Locations
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Incyte Medical Monitor Incyte Corporation

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03059823     History of Changes
Other Study ID Numbers: INCMGA 0012-101
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Incyte Corporation:
Solid tumors
Metastatic cancer

Additional relevant MeSH terms:
Neoplasms