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 Malignancies
  • 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:Number of Participants With Treatment-related Adverse Events
Time Frame:From screening through 60 days after end of treatment, up to 11 months
Safety Issue:
Description:Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment

Secondary Outcome Measures

Measure:Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma
Time Frame:Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
Safety Issue:
Description:To evaluate the Cmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
Measure:Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949
Time Frame:Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
Safety Issue:
Description:To evaluate the AUC0-t of INCAGN01949 in subjects with advanced or metastatic solid tumors
Measure:Objective Response Rate Per RECIST and Modified RECIST
Time Frame:Baseline and every 8 weeks,up to 11 months
Safety Issue:
Description:ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Measure:Duration of Response Per RECIST and Modified RECIST
Time Frame:Baseline and every 8 weeks, up to 11 months
Safety Issue:
Description:ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Measure:Progression-free Survival Per RECIST and Modified RECIST
Time Frame:Baseline and every 8 weeks, up to 11 months
Safety Issue:
Description:ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Measure:Duration of Disease Control Per RECIST and Modified RECIST
Time Frame:Baseline and every 8 weeks, up to 11 months
Safety Issue:
Description:ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 and mRECIST v1.1. by investigator determination.
Measure:Time to Maximum Concentration of INCAGN01949 in Plasma
Time Frame:Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
Safety Issue:
Description:To evaluate the Tmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
Measure:Summary of Trough Concentrations(Cmin) of INCAGN01949
Time Frame:Pre-infusion for cycles 1,2,3,4,5,6 and 7, 10-minutes, 4 hrs, 24 hrs post-infusion, Day 8 for cycles 1 & 6
Safety Issue:
Description:To evaluate the Cmin of INCAGN01949 in subjects with advanced or metastatic solid tumors. Cmin is the minimum observed concentration of INCAGN1949

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Completed
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

May 12, 2020