search
Back to results

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

Primary Purpose

Advanced Malignancies, Metastatic Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
INCAGN01949
Sponsored by
Incyte Biosciences International Sàrl
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Malignancies focused on measuring Solid tumor, adenocarcinoma of the endometrium, ovarian cancer, renal cell carcinoma, melanoma, non-small cell lung cancer, OX40, immunoglobulin G monoclonal antibody

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rutgers, The State University of New Jersey
  • New York University Clinical Cancer Center
  • Vanderbilt University Medical Center
  • MD Anderson Cancer Center
  • Vall d'Hebron Institute of Oncology (VHIO)
  • University Hospital of Laussane (CHUV)
  • University College Hospital
  • University of Oxford

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

INCAGN01949

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-related Adverse Events
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment

Secondary Outcome Measures

Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma
To evaluate the Cmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949
To evaluate the AUC0-t of INCAGN01949 in subjects with advanced or metastatic solid tumors
Objective Response Rate Per RECIST and Modified RECIST
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.
Duration of Response Per RECIST and Modified RECIST
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.
Progression-free Survival Per RECIST and Modified RECIST
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.
Duration of Disease Control Per RECIST and Modified RECIST
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.
Time to Maximum Concentration of INCAGN01949 in Plasma
To evaluate the Tmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
Summary of Trough Concentrations(Cmin) of INCAGN01949
To evaluate the Cmin of INCAGN01949 in subjects with advanced or metastatic solid tumors. Cmin is the minimum observed concentration of INCAGN1949

Full Information

First Posted
October 3, 2016
Last Updated
May 6, 2020
Sponsor
Incyte Biosciences International Sàrl
search

1. Study Identification

Unique Protocol Identification Number
NCT02923349
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
October 31, 2016 (Actual)
Primary Completion Date
March 26, 2019 (Actual)
Study Completion Date
March 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Biosciences International Sàrl

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Malignancies, Metastatic Cancer
Keywords
Solid tumor, adenocarcinoma of the endometrium, ovarian cancer, renal cell carcinoma, melanoma, non-small cell lung cancer, OX40, immunoglobulin G monoclonal antibody

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
INCAGN01949
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
INCAGN01949
Intervention Description
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 Measure Information:
Title
Number of Participants With Treatment-related Adverse Events
Description
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
Time Frame
From screening through 60 days after end of treatment, up to 11 months
Secondary Outcome Measure Information:
Title
Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma
Description
To evaluate the Cmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
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
Title
Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949
Description
To evaluate the AUC0-t of INCAGN01949 in subjects with advanced or metastatic solid tumors
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
Title
Objective Response Rate Per RECIST and Modified RECIST
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.
Time Frame
Baseline and every 8 weeks,up to 11 months
Title
Duration of Response Per RECIST and Modified RECIST
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.
Time Frame
Baseline and every 8 weeks, up to 11 months
Title
Progression-free Survival Per RECIST and Modified RECIST
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.
Time Frame
Baseline and every 8 weeks, up to 11 months
Title
Duration of Disease Control Per RECIST and Modified RECIST
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.
Time Frame
Baseline and every 8 weeks, up to 11 months
Title
Time to Maximum Concentration of INCAGN01949 in Plasma
Description
To evaluate the Tmax of INCAGN01949 in subjects with advanced or metastatic solid tumors.
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
Title
Summary of Trough Concentrations(Cmin) of INCAGN01949
Description
To evaluate the Cmin of INCAGN01949 in subjects with advanced or metastatic solid tumors. Cmin is the minimum observed concentration of INCAGN1949
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John E. Janik, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Rutgers, The State University of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
New York University Clinical Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Vall d'Hebron Institute of Oncology (VHIO)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
University Hospital of Laussane (CHUV)
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
University College Hospital
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
University of Oxford
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
36316061
Citation
Davis EJ, Martin-Liberal J, Kristeleit R, Cho DC, Blagden SP, Berthold D, Cardin DB, Vieito M, Miller RE, Hari Dass P, Orcurto A, Spencer K, Janik JE, Clark J, Condamine T, Pulini J, Chen X, Mehnert JM. First-in-human phase I/II, open-label study of the anti-OX40 agonist INCAGN01949 in patients with advanced solid tumors. J Immunother Cancer. 2022 Oct;10(10):e004235. doi: 10.1136/jitc-2021-004235.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs