Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
Eligible patients will be assigned to a treatment cohort, depending on their tumour type and treatment history. All enrolled patients will receive either 25mg or 100mg oral INCB099280, once daily or twice daily, on each day of each 28-day cycle.
Conditions
This trial is treating people with select advanced cancers, including Cutaneous Squamous Cell Carcinoma, Urothelial Cancer, Cervical Cancer, Hepatocellular (Liver) Cancer, Oesophageal Squamous Cell Carcinoma, Merkel Cell Carcinoma, Small-cell Lung Cancer, Mesothelioma and Nasopharyngeal (Nose) Carcinoma
Eligibility
Inclusion
- 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.
- Eastern Cooperative Oncology Group performance status score of 0 or 1.
- Life expectancy > 12 weeks.
- Willingness to avoid pregnancy or fathering children.
Exclusion
- Laboratory values outside the Protocol-defined ranges.
- Clinically significant cardiac disease.
- History or presence of an electrocardiogram 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 Human Immunodeficiency Virus (HIV)
- Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
Inclusion
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Incyte Corporation
Scientific Title
A Phase 1 Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Select Advanced Solid Tumors
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