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Evaluating the safety of INCA33890 for advanced or metastatic solid tumors

A Phase 1, Open-Label, Multicenter Study of INCA33890 in Participants With Advanced or Metastatic Solid Tumors

Phase 1 Interventional Incyte Corporation · NCT05836324

This study is testing a new drug called INCA33890 to see if it's safe for people with advanced solid tumors who haven't had success with other treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment408 (estimated)
Ages18 Years and up
SexAll
SponsorIncyte Corporation Industry-sponsored
Drugs / interventionsprednisone
Locations36 sites (Los Angeles, California and 35 other locations)
Trial IDNCT05836324 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and tolerability of INCA33890 in patients with advanced or metastatic solid tumors. It will determine the maximum tolerated dose (MTD) and/or recommended dose escalation (RDE) of the drug, alongside other treatments like bevacizumab and FOLFIRI. Participants will undergo mandatory tumor biopsies to evaluate treatment effects. The study is designed for individuals who have not responded to or are ineligible for existing therapies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed advanced or metastatic solid tumors who have experienced disease progression after prior treatments.

Not a fit: Patients with additional malignancies requiring active treatment or those who have not recovered from prior therapy toxicities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced or metastatic solid tumors who have limited alternatives.

How similar studies have performed: Other studies evaluating similar treatment approaches have shown promise, but the specific use of INCA33890 in this context is novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Los Angeles, California and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Solid TumorsAdvanced Solid TumorsMetastatic Solid TumorsINCA33890
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.