Clinical Trials /

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

NCT02923349

Description:

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.

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

Completed

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Phase 1/2, Open-Label, Dose-Escalation, Safety Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors
  • Official Title: A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: INCAGN 1949-101
  • NCT ID: NCT02923349

Conditions

  • Advanced Cancer
  • Metastatic Cancer

Interventions

DrugSynonymsArms
INCAGN01949INCAGN01949

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
INCAGN01949Experimental
  • INCAGN01949

Eligibility 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.
      
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
Time Frame: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 INCAGN01949 in serum
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 INCAGN01949
Time Frame:Protocol-defined timepoints in treatment Cycles 1-7, up to 4 months
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:Defined as percentage of subjects having complete response or partial response
Measure: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
Safety Issue:
Description:Defined as the time from earliest date of disease response until earliest date of disease progression or death.
Measure: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
Safety Issue:
Description:Defined as the time from date of first dose of study drug until the earliest date of disease progression or death.
Measure: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
Safety Issue:
Description:Measured from first report of stable disease or better until disease progression or death.

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
  • ovarian cancer
  • renal cell carcinoma
  • melanoma
  • non-small cell lung cancer
  • OX40
  • immunoglobulin G monoclonal antibody

Last Updated

January 10, 2018