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.
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
Drug | Synonyms | Arms |
---|
INCAGN01949 | | INCAGN01949 |
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
Name | Type | Description | Interventions |
---|
INCAGN01949 | Experimental | | |
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