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A Phase I Study of INCB099280 in Combination With Ipilimumab in Participants With Selected Solid Tumors
EU CTIS ID: 2023-503243-34-00
What this study is testing
To determine the safety and tolerability and identify 1 or more RDEs of INCB099280 when administered in combination with ipilimumab in participants with advanced solid tumors.
- Human Pharmacology (Phase I)- Other
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.
- Aged 18 years or older at the time of signing the ICF.
- Prior systemic therapy, diagnoses, and disease settings in the protocol
- Must be willing and able to conform to and comply with all Protocol requirements, including all scheduled visits, Protocol procedures, and the ability to swallow oral medication.
- An ECOG performance score of 0 or 1.
- Life expectancy > 3 months, in the opinion of the investigator.
You likely can't join if
- Has a 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. Note: The time requirement for no evidence of disease for 3 years does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, other noninvasive or indolent malignancies, or other in situ cancers.
- Participation in another interventional clinical study while receiving INCB099280.
- Treatment with anticancer medications or investigational drugs within the following intervals before the first administration of study treatment: a. At least 14 days for chemotherapy or targeted smallmolecule therapy. b. At least 28 days for a prior monoclonal antibody used for anticancer therapy. c. At least 28 days or 5 half-lives (whichever is longer) for all other investigational study drugs or devices. Note: Participants receiving bisphosphonates and/or denosumab are eligible for enrollment.
- Participants with impaired cardiac function or clinically significant cardiac disease: • New York Heart Association Class III or IV cardiac disease, including preexisting clinically significant ventricular arrhythmia, congestive heart failure, or cardiomyopathy • Unstable angina pectoris • Acute myocardial infarction ≤ 6 months before study participation • Other clinically significant heart disease (ie, uncontrolled ≥ Grade 3 hypertension)
- History or evidence of interstitial lung disease including noninfectious pneumonitis.
- Active infection requiring systemic therapy, with the exception of HIV and hepatitis as noted.
See the full eligibility criteria
Who can join
- Ability to comprehend and willingness to sign a written ICF for the study.
- Aged 18 years or older at the time of signing the ICF.
- Prior systemic therapy, diagnoses, and disease settings in the protocol
- Must be willing and able to conform to and comply with all Protocol requirements, including all scheduled visits, Protocol procedures, and the ability to swallow oral medication.
- An ECOG performance score of 0 or 1.
- Life expectancy > 3 months, in the opinion of the investigator.
- Histologically confirmed solid tumors with measurable disease per RECIST v1.1.
- Willingness to avoid pregnancy or fathering children based on the criteria below. a. Male participants with reproductive potential must agree to take appropriate precautions to avoid fathering children from screening through 100 days after the last dose of study treatment (or longer as appropriate based on country-specific requirements) and must refrain from donating sperm during this period. Permitted methods in preventing pregnancy (see Appendix A) should be communicated to the participants and their understanding confirmed. b. Female participants who are WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test before the first dose on Day 1 and must agree to take appropriate precautions to avoid pregnancy from screening through 190 days after the last dose of study treatment and must refrain from donating oocytes during this period. Permitted methods in preventing pregnancy (see Appendix A) should be communicated to the participants and their understanding confirmed. c. Female participants not considered to be of childbearing potential as defined in Appendix A are eligible.
What rules you out
- Has a 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. Note: The time requirement for no evidence of disease for 3 years does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, other noninvasive or indolent malignancies, or other in situ cancers.
- Participation in another interventional clinical study while receiving INCB099280.
- Treatment with anticancer medications or investigational drugs within the following intervals before the first administration of study treatment: a. At least 14 days for chemotherapy or targeted smallmolecule therapy. b. At least 28 days for a prior monoclonal antibody used for anticancer therapy. c. At least 28 days or 5 half-lives (whichever is longer) for all other investigational study drugs or devices. Note: Participants receiving bisphosphonates and/or denosumab are eligible for enrollment.
- Participants with impaired cardiac function or clinically significant cardiac disease: • New York Heart Association Class III or IV cardiac disease, including preexisting clinically significant ventricular arrhythmia, congestive heart failure, or cardiomyopathy • Unstable angina pectoris • Acute myocardial infarction ≤ 6 months before study participation • Other clinically significant heart disease (ie, uncontrolled ≥ Grade 3 hypertension)
- History or evidence of interstitial lung disease including noninfectious pneumonitis.
- Active infection requiring systemic therapy, with the exception of HIV and hepatitis as noted.
- History of organ transplantation, including allogeneic stem cell transplantation.
- 15. Anamnéza transplantácie orgánov vrátane alogénnej transplantácie kmeňových buniek
- Postoperative complications preventing the participant from adhering to Protocol assessments and procedures.
- Use of systemic antibiotics within 28 days before the first dose of study treatment.
- Use of probiotic supplements within 28 days before the first dose of study treatment.
- Presence of gastrointestinal conditions that may affect drug absorption, as well as those that interfere with gastrointestinal transit, including gastric bypass surgery, gastric sleeve, or lap band.
- Received a live vaccine within 28 days before the planned start of study treatment. Note: Examples of live vaccines include but are not limited to the following: measles, mumps, rubella, chickenpox/zoster, yellow fever, rabies, BCG, and typhoid. 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.
- Treatment with potent and moderate CYP3A4/5 inhibitors or inducers (see Appendix D). Note: A washout period ≥ 10 days before the first dose of study treatment is required for prior treatment with potent and moderate CYP3A4/5 inhibitors/inducers.
- Unable to be weaned off of a prohibited medication as described in Section 6.7.3 before the initiation of study treatment.
- Participants with laboratory values at screening defined in Table 7.
- Clinically significant ECG abnormality, including average QTcF interval > 480 milliseconds of triplicate ECGs.
- Active HBV or HCV defined as follows (testing must be performed to determine eligibility): a. Detectable HBV DNA (viral load) and HBsAg positive. 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. Positive anti-HCV result and quantitative HCV RNA (viral load) result greater than the lower limit of detection for the assay. Note: Participants previously treated for HCV with clearance are specifically allowed in the study.
- Female participants who are breastfeeding from the screening visit through 190 days after the last dose of study treatment.
- Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
- 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.
- 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 is receiving chronic systemic corticosteroid therapy of a daily dose exceeding 10 mg of prednisone or equivalent.
- Known HIV infection with 1 or more of the following: CD4+ T-cell count < 200 cells/μL, detectable viral load per parameters of assay, or antiretroviral regimen containing potent and moderate CYP3A4/5 inhibitors or inducers. Note: Participants modifying their HIV regimen to include only drugs without CYP3A4/5 inhibitors or inducers must be on a stable regimen for > 28 days.
- Has CNS metastases requiring treatment and/or leptomeningeal disease. Note: Participants with untreated CNS metastases are excluded if any of the followingapply: participants are symptomatic, metastases require increasing corticosteroids and/or a corticosteroid dose of more than 1 mg of dexamethasone daily (or equivalent), or participants have lesions with significant edema. Note: Participants with treated CNS metastases are excluded if any of the following apply: CNS metastatic disease is progressing, participants are not clinically stable within 2 weeks before Cycle 1 Day 1, or metastases require increasing corticosteroids and/or a corticosteroid dose of more than 1 mg of dexamethasone daily (or equivalent).
- Toxicity from prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of anemia not requiring transfusion support and any grade of alopecia).
- For Part 1 (dose escalation): Prior receipt of an anti–CTLA-4 therapy. For Part 2 (dose expansion): Prior receipt of anti CTLA-4 therapy
- Received thoracic radiation of > 30 Gy within 6 months before the first dose of study treatment. Note: Participants must have recovered from all radiationrelated toxicities to ≤ Grade 1 and not require corticosteroids.
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Brazil
- South Africa
- Canada
- Australia
- United States
- Turkey
- Mexico
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 Korea, Republic of; Brazil; South Africa; Canada; Australia; United States 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.