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 Cancer
- 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: | Safety and tolerability will be assessed by monitoring frequency, duration, and severity of adverse events |
Time Frame: | From screening through 60 days after end of treatment, up to 18 months. |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Maximum observed concentration (Cmax) of INCAGN01949 in serum |
Time Frame: | Protocol-defined timepoints in treatment Cycles 1-7, up to 4 months |
Safety Issue: | |
Description: | |
Measure: | Area under the single-dose concentration-time curve (AUC0-t) of INCAGN01949 |
Time Frame: | Protocol-defined timepoints in treatment Cycles 1-7, up to 4 months |
Safety Issue: | |
Description: | |
Measure: | Objective response rate per RECIST and modified RECIST |
Time Frame: | Baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter for duration of study participation, up to 18 months |
Safety Issue: | |
Description: | Defined as percentage of subjects having complete response or partial response |
Measure: | Duration of response per RECIST and modified RECIST |
Time Frame: | Baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter for duration of study participation, up to 18 months |
Safety Issue: | |
Description: | Defined as the time from earliest date of disease response until earliest date of disease progression or death. |
Measure: | Progression-free survival per RECIST and modified RECIST |
Time Frame: | Baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter for duration of study participation, up to 18 months |
Safety Issue: | |
Description: | Defined as the time from date of first dose of study drug until the earliest date of disease progression or death. |
Measure: | Duration of disease control per RECIST and modified RECIST |
Time Frame: | Baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter for duration of study participation, up to 18 months |
Safety Issue: | |
Description: | Measured from first report of stable disease or better until disease progression or death. |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
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
January 10, 2018