NCT05836324 A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors
| NCT ID | NCT05836324 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Incyte Corporation |
| Condition | Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 408 participants |
| Start Date | 2023-07-24 |
| Primary Completion | 2027-01-13 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 408 participants in total. It began in 2023-07-24 with a primary completion date of 2027-01-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05836324 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05836324 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05836324 currently recruiting?
Yes, NCT05836324 is actively recruiting participants. Contact the research team at medinfo@incyte.com for enrollment information.
Where is the NCT05836324 trial being conducted?
This trial is being conducted at Los Angeles, United States, Los Angeles, United States, Boston, United States, Grand Rapids, United States and 11 additional locations.
Who is sponsoring the NCT05836324 clinical trial?
NCT05836324 is sponsored by Incyte Corporation. The trial plans to enroll 408 participants.