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

NCT05836324

RecruitingPhase 1

Sponsor: Incyte Corporation

Conditions: Solid Tumors, Advanced Solid Tumors, Metastatic Solid Tumors

Interventions: INCA33890, bevacizumab, FOLFIRI, FOLFOX, Cetuximab

Countries: United States, China, Denmark, France, Italy, Japan, Spain, Switzerland

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (39)
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Boston, Massachusetts, United States
  • Grand Rapids, Michigan, United States
  • Hackensack, New Jersey, United States
  • Mineola, New York, United States
  • New York, New York, United States
  • Philadelphia, Pennsylvania, United States
  • Providence, Rhode Island, United States
  • Houston, Texas, United States
  • San Antonio, Texas, United States
  • Beijing, China
  • Beijing, China
  • Hangzhou, China
  • Copenhagen, Denmark
  • Herlev, Denmark
  • Odense C, Denmark
  • Vejle, Denmark
  • Lyon, France
  • Villejuif, France
  • Milan, Italy
  • Rozzano, Italy
  • Verona, Italy
  • Hirakata, Japan
  • Tokyo, Japan
  • Tokyo, Japan
  • Barcelona, Spain
  • Barcelona, Spain
  • Madrid, Spain
  • Madrid, Spain
  • + 9 more on CT.gov