A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors

Launched by INCYTE CORPORATION · Apr 26, 2023

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called INCA33890 for people with advanced or metastatic solid tumors, which are cancers that have spread beyond their original site. The main goal of the study is to see how safe this treatment is and to identify the highest dose that can be given without causing serious side effects. The trial is currently looking for participants aged 18 and older who have already tried other treatments but have not seen improvements or cannot receive standard therapies for their cancer.

To be eligible for the study, participants should have a confirmed diagnosis of advanced or metastatic cancer and must be willing to undergo biopsies (small tissue samples) to help researchers evaluate the treatment's effect. Additionally, they should be in relatively good health, with a performance status that allows them to perform daily activities. However, certain conditions may disqualify individuals, including having other active cancers, significant heart problems, or certain infections. If someone joins the trial, they can expect close monitoring and support throughout the treatment process. This study is an important step in finding new options for people facing challenging cancer diagnoses.

Gender

ALL

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.