Trials / Completed
CompletedNCT04580485
INCB106385 Alone or in Combination With Immunotherapy in Advanced Solid Tumors
A Phase 1, Open-Label, Multicenter Study of INCB106385 as Monotherapy or in Combination With Immunotherapy in Participants With Advanced Solid Tumors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- Incyte Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, open-label, dose-escalation/dose-expansion Phase 1 clinical study to investigate the safety, tolerability, PK profile, pharmacodynamics, and preliminary clinical efficacy of INCB106385 when given as monotherapy or in combination with INCMGA00012 in participants with selected CD8 T-cell-positive advanced solid tumors including SCCHN, NSCLC, ovarian cancer, CRPC, TNBC, bladder cancer, and specified GI malignancies (defined as CRC, gastric/GEJ cancer, HCC, PDAC, or SCAC)
Conditions
- Ovarian Cancer
- Bladder Cancer
- Non Small Cell Lung Cancer
- Squamous Cell Carcinoma of Head and Neck
- Triple Negative Breast Cancer
- Castration Resistant Prostate Cancer
- Colorectal Cancer
- Gastric/ Gastroesophageal Junction
- Hepatocellular Carcinoma
- Pancreatic Ductal Adenocarcinoma
- Squamous Carcinoma of the Anal Canal
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | INCB106385 | INCB106385 will be administered orally QD |
| DRUG | INCMGA00012 | INCMGA0012 will be administered IV once every 4 weeks (Q4W) |
Timeline
- Start date
- 2021-02-03
- Primary completion
- 2024-01-22
- Completion
- 2024-01-22
- First posted
- 2020-10-08
- Last updated
- 2025-07-11
Locations
27 sites across 6 countries: United States, Belgium, France, Italy, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04580485. Inclusion in this directory is not an endorsement.