Metastatic Cancer Clinical Trial
Official title:
A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors
Verified date | May 2020 |
Source | Incyte Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Incyte Biosciences International Sàrl |
United States, Spain, Switzerland, United Kingdom,
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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