A Phase I Study of INCB099280 in Combination With Ipilimumab in Participants With Selected Solid Tumors
- Conditions
- Solid tumorMedDRA version: 21.1Level: PTClassification code: 10027480Term: Metastatic malignant melanoma Class: 100000004864MedDRA version: 21.0Level: PTClassification code: 10052360Term: Colorectal adenocarcinoma Class: 100000004864MedDRA version: 21.1Level: LLTClassification code: 10038407Term: Renal cell cancer Class: 10029104MedDRA version: 20.0Level: LLTClassification code: 10010036Term: Colorectal carcinoma Class: 10029104MedDRA version: 20.0Level: PTClassification code: 10073071Term: Hepatocellular carcinoma Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10025650Term: Malignant melanoma Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10025671Term: Malignant melanoma stage IV Class: 100000004864MedDRA version: 20.0Level: HLTClassification code: 10027156Term: Skin melanomas (excl ocular) Class: 10040785Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-503243-34-00
- Lead Sponsor
- Incyte Corp.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 124
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.
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 kmenových 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. Detectabl
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method