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A PHASE 2 STUDY EVALUATING INCB099280 IN PARTICIPANTS WITH SELECT SOLID TUMORS WHO ARE IMMUNE CHECKPOINT INHIBITOR–NAÏVE
EU CTIS ID: 2022-502716-37-00
What this study is testing
To determine the safety, tolerability, and preliminary efficacy of INCB099280 400 mg BID, 600 mg BID, and 800 mg BID in participants with advanced solid tumors.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Ability to comprehend and willingness to sign a written ICF for the study.
- Age 18 years or older inclusive at the time of signing the ICF.
- Prior systemic therapy, diagnoses, and disease settings as follows: a. Immunotherapy naive b. Measurable disease per RECIST v1.1 c. One of the following disease settings: see protocol
- ECOG performance score of 0 or 1 (except for UC, where a score of up to 2 is permitted).
- Life expectancy > 3 months
- Willingness to avoid pregnancy or fathering children
You likely can't join if
- Known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of disease recurrence for 3 years since initiation of that therapy.
- Presence of gastrointestinal conditions that may affect drug absorption, as well as those that interfere with gastrointestinal transit
- Any autoimmune disease requiring systemic treatment in the past 5 years, including corticosteroids of a daily dose exceeding 10 mg of prednisone or equivalent
- Diagnosis of primary immunodeficiency or receiving chronic systemic steroid therapy at a daily dose exceeding 10 mg of prednisone or equivalent
- HIV infection and any one or more of the following: CD4+ T-cell count < 200 cells/µL, detectable viral load per parameters of assay, or antiretroviral therapy regimen containing moderate or potent CYP3A4/CYP3A5 inhibitors or inducers
- Active infection requiring systemic therapy, with the exception of HIV and hepatitis
See the full eligibility criteria
Who can join
- Ability to comprehend and willingness to sign a written ICF for the study.
- Age 18 years or older inclusive at the time of signing the ICF.
- Prior systemic therapy, diagnoses, and disease settings as follows: a. Immunotherapy naive b. Measurable disease per RECIST v1.1 c. One of the following disease settings: see protocol
- ECOG performance score of 0 or 1 (except for UC, where a score of up to 2 is permitted).
- Life expectancy > 3 months
- Willingness to avoid pregnancy or fathering children
What rules you out
- Known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of disease recurrence for 3 years since initiation of that therapy.
- Presence of gastrointestinal conditions that may affect drug absorption, as well as those that interfere with gastrointestinal transit
- Any autoimmune disease requiring systemic treatment in the past 5 years, including corticosteroids of a daily dose exceeding 10 mg of prednisone or equivalent
- Diagnosis of primary immunodeficiency or receiving chronic systemic steroid therapy at a daily dose exceeding 10 mg of prednisone or equivalent
- HIV infection and any one or more of the following: CD4+ T-cell count < 200 cells/µL, detectable viral load per parameters of assay, or antiretroviral therapy regimen containing moderate or potent CYP3A4/CYP3A5 inhibitors or inducers
- Active infection requiring systemic therapy, with the exception of HIV and hepatitis
- History of organ transplantation, including allogeneic stem cell transplantation.
- Known hypersensitivity or severe reaction to any component of study drug or formulation components.
- Postoperative complications preventing the participant from adhering protocol assessments and procedures.
- Receipt of systemic antibiotics within 28 days of first dose of study treatment.
- Probiotic usage is prohibited during screening and throughout the study treatment period.
- CNS metastases requiring treatment and/or leptomeningeal disease.
- Received a live vaccine within 28 days of the planned start of study drug. Note: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, some shingles, yellow fever, rabies, BCG, and typhoid vaccines. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live-attenuated vaccines and are not allowed. Note: If enrolled, participants should not receive live vaccine during the study and up to 28 days after the last dose of study drug.
- Treatment with moderate and potent CYP3A4/CYP3A5 inhibitors or inducers
- Unable to be weaned off of a prohibited medication before the initiation of study treatment.
- Participants with laboratory values at screening as defined in the protocol
- Clinically significant ECG abnormality, including average QTcF interval > 480 milliseconds
- Active HBV or HCV as follows (testing must be performed): a.Detectable HBV DNA (viral load) and HBsAg. b. Participants with chronic HBV infection with active disease who meet the criteria for anti-HBV therapy are required to be on a suppressive antiviral therapy prior to initiation of study treatment. c. Active HCV is defined as a positive HCV antibody result and quantitative HCV RNA (viral load) result greater than the lower limit of detection
- Pregnant, expecting to conceive, or breastfeeding or expecting to father children
- Any condition that would, in the investigator's judgment, interfere with full participation in the study
- The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection, or who are unable to express their consent per article L.1121-8 of the French Public Health Code, not affiliated to a social security per article L.1121-8-1 of the French Public Health Code.
- Toxicity from prior therapy that has not recovered to ≤ Grade 1 or baseline
- Prior receipt of an anti–PD-1, anti–PD-L1, or anti–PD-L2 agent or treatment with an immune modulator
- Received thoracic radiation of > 30 Gy within 6 months of the first dose of study treatment.
- Participation in another interventional clinical study while receiving INCB099280.
- Treatment with anticancer medications or investigational drugs within the detailed intervals before the first administration of study drug
- Impaired cardiac function or clinically significant cardiac disease
- History or evidence of interstitial lung disease including noninfectious pneumonitis.
The study team makes the final eligibility decision.
Where it's taking place
- New Zealand
- South Africa
- Korea, Republic of
- Georgia
- Turkey
- Australia
- Brazil
- Chile
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Zealand; South Africa; Korea, Republic of; Georgia; Turkey; Australia and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.