Clinical Trials /

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

NCT02697591

Description:

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.

Related Conditions:
  • Endometrial Adenocarcinoma
  • Malignant Solid Tumor
  • Melanoma
  • Non-Small Cell Lung Carcinoma
  • Renal Cell Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: An Open-Label, Dose-Escalation, Safety Study of INCAGN01876 in Subjects 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

Clinical Trial IDs

  • ORG STUDY ID: INCAGN 1876-101
  • NCT ID: NCT02697591

Conditions

  • Advanced Cancer
  • Metastatic Cancer

Interventions

DrugSynonymsArms
INCAGN01876INCAGN01876

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
INCAGN01876Experimental
  • INCAGN01876

Eligibility 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 that required systemic treatment in the past 2 years
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incyte Biosciences International Sàrl

Trial 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)

Last Updated

August 2, 2017