Phase 2
N=87
A Phase 1/2, Open-Label, Dose-Escalation, Safety Study of INCAGN01949 in Subjects With Advanced or Metastatic Solid Tumors
Advanced Malignancies · Metastatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02923349 ↗Enrolled (actual)
87
Serious AEs
39.1%
Results posted
May 2020
Primary outcome: Primary: Number of Participants With Treatment-related Adverse Events — 4; 4; 21; 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- INCAGN01949 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Incyte Biosciences International Sàrl
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-related Adverse Events |
4; 4; 21; 17; 22; 11 | — |
| SECONDARY Maximum Observed Concentration (Cmax) of INCAGN01949 in Plasma |
1630; 5820; 22300; 39200; 84900; 207000 | — |
| SECONDARY Area Under the Single-dose Concentration-time Curve (AUC0-t) of INCAGN01949 |
185; 904; 2370; 5400; 10000; 28300 | — |
| SECONDARY Objective Response Rate Per RECIST and Modified RECIST |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Duration of Response Per RECIST and Modified RECIST |
192 | — |
| SECONDARY Progression-free Survival Per RECIST and Modified RECIST |
57; 47.5; 54.0; 56.0; 52.0; 125.0 | — |
| SECONDARY Duration of Disease Control Per RECIST and Modified RECIST |
0; 57; 64; 57; NA; 120 | — |
| SECONDARY Time to Maximum Concentration of INCAGN01949 in Plasma |
0.64; 2.53; 4.3; 0.63; 0.6; 0.7 | — |
| SECONDARY Summary of Trough Concentrations(Cmin) of INCAGN01949 |
303; 1890; 3620; 8880; 17000; 41000 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02923349). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.