NCT05836324 · Incyte Corporation
A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors
What this study is about
To evaluate the safety, tolerability, and DLTs and determine the MTD and/or RDE(s) of INCA33890 in participants with select advanced or metastatic solid tumors.
View original scientific description
To evaluate the safety, tolerability, and DLTs and determine the MTD and/or RDE(s) of INCA33890 in participants with select advanced or metastatic solid tumors.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- ≥18 years old
- Histologically or cytologically confirmed advanced or metastatic malignancies as defined in the protocol.
- Part 1: Participants must have experienced disease progression after treatment with, be intolerant to, or be ineligible for, or refused available therapies, including anti-PD-(L)1 or anti-CTLA4 therapy if applicable, that are known to confer clinical benefit. Part 2: depending on cohort, participants may have received or not prior treatment for the malignancy under study.
- ECOG performance status score of 0 or 1.
- Willingness to undergo pre- and on-treatment tumor biopsy (core or excisional). Biopsies are mandatory depending on the cohorts.
- Presence of measurable disease according to RECIST v1.1.
Exclusion criteria
- Any known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years.
- Not recovered to ≤ Grade 1 or baseline from residual toxicities of prior therapy.
- Has active autoimmune disease requiring systemic immunosuppression with corticosteroids.
- Brain or CNS metastases untreated or that have progressed.
- History of organ transplant, including allogeneic stem cell transplantation.
- History of clinically significant or uncontrolled cardiac disease.
- Active HBV, active HCV, or HIV positive.
- Is on chronic systemic steroids (\> 10 mg/day of prednisone or equivalent).
- Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment
- Participants that have been initiated on or had modifications in anticoagulation therapies within the last 3 months prior to first dose of treatment.
- Significant concurrent, uncontrolled medical condition, eg:
- Cardiovascular: Participants with known vasculitis, aneurisms, and other vascular malformations of clinical significance or history of myocarditis.
- Gastrointestinal: Any bowel obstruction within 60 days prior to C1D1.
- Participants with adequate laboratory values within the protocol defined ranges. Other protocol-defined Inclusion/Exclusion Criteria may apply.
Where
- Los Angeles, California
- Boston, Massachusetts
- Grand Rapids, Michigan
- Hackensack, New Jersey
- Mineola, New York
- New York, New York
- Philadelphia, Pennsylvania
- Providence, Rhode Island
- Houston, Texas
- San Antonio, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 18, 2025 · Source of record for eligibility and locations