Sponsors

Lead Sponsor

Incyte Corporation

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Must have disease progression after treatment with available therapies that are known to confer clinical benefit or must be intolerant to or ineligible for standard treatment.
•Histologically confirmed advanced solid tumors (protocol-defined select solid tumors) with measurable lesions per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) that are considered nonamenable to surgery or other curative treatments or procedures.
•ECOG performance status score of 0 or 1.
•Life expectancy \> 12 weeks.
•Willingness to avoid pregnancy or fathering children.

Exclusion Criteria

•Laboratory values outside the Protocol-defined ranges.
•Clinically significant cardiac disease.
•History or presence of an ECG that, in the investigator's opinion, is clinically meaningful.
•Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed (eg, evidence of new or enlarging brain metastasis or new neurological symptoms attributable to brain or CNS metastases).
•Known additional malignancy that is progressing or requires active treatment.
•Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy (including prior IO) and/or complications from prior surgical intervention before starting study treatment.
•Prior receipt of an anti-PD-L1 therapy.
•Treatment with anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
•A 28-day washout for systemic antibiotics is required.
•Probiotic usage while on study and during screening is prohibited.
•Active infection requiring systemic therapy.
•Known history of HIV
•Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.

Related studies

RECRUITINGPhase 1

A Study to Test the Safety and Tolerability of SBO-154 in Patients With Advanced Solid Tumors.

NCT07042100 · Advanced Solid Tumors

RECRUITINGPhase 1/2

Phase 1/2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing Solid Tumors

NCT07589530 · Advanced Solid Tumors, Metastatic Solid Tumors, and more

RECRUITINGPhase 1

A Phase I Study of BAY3498264 Given Together With Sotorasib in Participants Who Have Advanced Solid Cancers With Specific Genetic Changes Called KRASG12C Mutation

NCT06659341 · Advanced Solid Tumors Harboring KRAS G12C Mutation

RECRUITINGPhase 1

A Study of DXC014 in Patients With Advanced Solid Tumors.

NCT07177937 · Small Cell Lung Cancer, Melanoma, and more

RECRUITINGPhase 2

Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patients With Head and Neck Cancer

NCT06532279 · Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, and more

View all related studies →

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors

What this study is about

Save this trial guide to your notes

Sponsors

Related studies

A Study to Test the Safety and Tolerability of SBO-154 in Patients With Advanced Solid Tumors.

Phase 1/2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing Solid Tumors

A Phase I Study of BAY3498264 Given Together With Sotorasib in Participants Who Have Advanced Solid Cancers With Specific Genetic Changes Called KRASG12C Mutation

A Study of DXC014 in Patients With Advanced Solid Tumors.

Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patients With Head and Neck Cancer

Trial snapshot

Condition

Locations shown

For caregivers