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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02923349
• Other study ID #: INCAGN 1949-101
• Status: Completed
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Advanced Malignancies
• Metastatic Cancer
• Neoplasm Metastasis

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