Phase 2
N=100
A Study of INCAGN01876 in Participants With Advanced or Metastatic Solid Tumors
Advanced Malignancies · Metastatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02697591 ↗Enrolled (actual)
100
Serious AEs
43.0%
Results posted
Feb 2021
Primary outcome: Primary: Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) and as Per the Severity — 4; 4; 4; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- INCAGN01876 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Incyte Biosciences International Sàrl
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) and as Per the Severity |
4; 4; 4; 3; 15; 18 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) |
781; 2700; 6450; 21,600; 66,000; 128,000 | — |
| SECONDARY Time to Maximum Concentration (Tmax) |
0.1; 0.1; 0.1; 0.1; 0.1; 0.1 | — |
| SECONDARY Minimum Observed Plasma Concentration Over the Dose Interval (Cmin) |
42.1; 460; 1110; 4910; 14,800; 25,600 | — |
| SECONDARY Area Under the Plasma Time Curve From Time = 0 to the Last Measurable Concentration (AUC0-t) |
70.7; 302; 850; 3130; 8880; 17,900 | — |
| SECONDARY Objective Response Rate (ORR) Per RECIST v1.1 and Modified RECISTv1.1 (mRECIST) |
0.0; 0.0; 25.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Duration of Response (DOR) Per RECIST and mRECIST |
NA; NA; 169.0; NA; NA; NA | — |
| SECONDARY Duration of Disease Control Per RECIST and mRECIST |
NA; NA; 169.0; 91.0; 58.5; 58.0 | — |
| SECONDARY Progression Free Survival (PFS) Per RECIST and mRECIST |
1.64; 1.84; 6.70; 1.48; 1.87; 1.87 | — |
Summary
This was an open-label, non-randomized Phase 1/2 safety study of INCAGN01876 in participants with advanced or metastatic solid tumors that was conducted in 2 parts. Part 1 is dose escalation and safety expansion which determines the optimal dose and maximum number of tolerated doses. Part 2 is dose expansion in which Part 1 recommended dose will be evaluated.
Eligibility Criteria
Inclusion Criteria
- Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.
- Part 1: Participants with advanced or metastatic solid tumors.
- Part 2: Participants with advanced or metastatic adenocarcinoma of endometrium, melanoma, non-small cell lung cancer, and renal cell carcinoma.
- Participants who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or participants who refuse standard treatment.
- Presence of measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
Exclusion Criteria
- Laboratory and medical history parameters not within the protocol-defined range.
- Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
- Has not recovered to ≤ Grade 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting therapy.
- Receipt of a live vaccine within 30 days of planned start of study therapy.
- Active autoimmune disease.
- Prior treatment with any tumor necrosis factor super family agonist.
- Known active central nervous system metastases and/or carcinomatous meningitis.
- Evidence of active, non-infectious pneumonitis or history of interstitial lung disease.
- Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
Data sourced from ClinicalTrials.gov (NCT02697591). 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.