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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02923349
Other study ID # INCAGN 1949-101
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date October 31, 2016
Est. completion date March 26, 2019

Study information

Verified date May 2020
Source Incyte Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 87
Est. completion date March 26, 2019
Est. primary completion date March 26, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
INCAGN01949
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.

Locations

Country Name City State
Spain Vall d'Hebron Institute of Oncology (VHIO) Barcelona
Switzerland University Hospital of Laussane (CHUV) Lausanne
United Kingdom University College Hospital London
United Kingdom University of Oxford Oxford
United States MD Anderson Cancer Center Houston Texas
United States Vanderbilt University Medical Center Nashville Tennessee
United States Rutgers, The State University of New Jersey New Brunswick New Jersey
United States New York University Clinical Cancer Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Incyte Biosciences International Sàrl

Countries where clinical trial is conducted

United States,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 From screening through 60 days after end of treatment, up to 11 months
Secondary Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma To evaluate the Cmax of INCAGN01949 in subjects with advanced or metastatic solid tumors. 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
Secondary 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 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
Secondary 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. Baseline and every 8 weeks,up to 11 months
Secondary 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. Baseline and every 8 weeks, up to 11 months
Secondary 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. Baseline and every 8 weeks, up to 11 months
Secondary 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. Baseline and every 8 weeks, up to 11 months
Secondary Time to Maximum Concentration of INCAGN01949 in Plasma To evaluate the Tmax of INCAGN01949 in subjects with advanced or metastatic solid tumors. 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
Secondary 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 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
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