Actively Recruiting
A Phase 1, Open-Label, Multicenter Study of INCA33890 in Participants With Advanced or Metastatic Solid Tumors
Led by Incyte Corporation · Updated on 2025-12-18
408
Participants Needed
36
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, dose limiting toxicities (DLTs), and the maximum tolerated dose (MTD) or recommended doses of the drug INCA33890 in adults with advanced or metastatic solid tumors. This phase 1, open-label, multicenter study aims to understand how this investigational drug works alone or combined with other cancer treatments in participants whose cancer has progressed or for whom standard treatments are not suitable. Participants will receive INCA33890 according to their assigned study group, which may include monotherapy or combinations with bevacizumab, FOLFIRI, FOLFOX, or cetuximab. Dosing is protocol-defined based on the cohort assignment, with distinct parts for dose escalation and dose expansion both for monotherapy and combination therapy groups. Throughout the study, participants will be monitored for dose limiting toxicities within 28 days and treatment-emerging adverse events for up to 2 years. Researchers will also assess tumor response rates, disease control, duration of response, and detailed pharmacokinetic measurements of INCA33890 at multiple timepoints throughout the treatment cycles and follow-up. The total duration of participation may extend up to 2 years, including safety monitoring and evaluation of treatment effects.
CONDITIONS
Brief Title
A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Histologically or cytologically confirmed advanced or metastatic malignancies as defined in the protocol
- Part 1: Disease progression after treatment with, intolerance to, or ineligibility for known beneficial therapies including anti-PD-(L)1 or anti-CTLA4 therapy if applicable
- Part 2: Depending on cohort, may have received or not prior treatment for the malignancy under study
- ECOG performance status score of 0 or 1
- Willing to undergo pre- and on-treatment tumor biopsies as required
- Measurable disease present according to RECIST v1.1
You will not qualify if you...
- Any other progressing malignancy or history of other malignancy within 2 years
- Not recovered to Grade 1 or baseline from residual toxicities of prior therapy
- Active autoimmune disease requiring systemic corticosteroids
- Untreated or progressing brain or CNS metastases
- History of organ transplant including allogeneic stem cell transplantation
- History of significant or uncontrolled cardiac disease
- Active hepatitis B, hepatitis C, or HIV infection
- On chronic systemic steroids exceeding 10 mg/day prednisone or equivalent
- Chronic or active infectious disease requiring systemic treatment
- Recent initiation or modification of anticoagulation therapy within 3 months prior to first dose
- Significant uncontrolled medical conditions such as vasculitis, aneurysms, vascular malformations, myocarditis, or recent bowel obstruction within 60 days
- Must have adequate laboratory values as defined by protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation.
Participants receive INCA33890 alone or in combination with other drugs at protocol-defined doses depending on their assigned cohort.
Regular visits during each treatment cycle for dosing and assessments
Duration - Up to 2 years
Participants are monitored for safety and treatment effects after stopping treatment.
Periodic visits for up to 2 years after treatment ends
Trial Site Locations
Total: 36 locations
1
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
Actively Recruiting
2
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
Actively Recruiting
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
Cancer and Hematology Centers of Western Michigan-Start Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
5
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
6
Nyu Langone Health - Long Island Hospital
Mineola, New York, United States, 11501
Actively Recruiting
7
Laura and Isaac Perlmutter Cancer Center
New York, New York, United States, 10016
Actively Recruiting
8
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
9
Lifespan Cancer Research Institute
Providence, Rhode Island, United States, 02903
Actively Recruiting
10
University of Texas Md Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
11
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
Actively Recruiting
12
Rigshospitalet Uni of Hospital of Copenhagen
Copenhagen, Denmark, 02100
Actively Recruiting
13
Herlev Og Gentofte Hospital
Herlev, Denmark, 02730
Actively Recruiting
14
Odense University Hospital
Odense C, Denmark, 05000
Actively Recruiting
15
Vejle Hospital
Vejle, Denmark, 07100
Actively Recruiting
16
Centre Leon Berard
Lyon, France, 69373
Actively Recruiting
17
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
18
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan, Italy, 20133
Actively Recruiting
19
Irccs Istituto Clinico Humanitas
Rozzano, Italy, 20089
Actively Recruiting
20
Centro Ricerche Cliniche Di Verona
Verona, Italy, 37134
Actively Recruiting
21
Kansai Medical University Hospital
Hirakata, Japan, 573-1191
Actively Recruiting
22
National Cancer Center Hospital
Tokyo, Japan, 104-0045
Actively Recruiting
23
The Cancer Institute Hospital of Jfcr
Tokyo, Japan, 135-0063
Actively Recruiting
24
Start Barcelona
Barcelona, Spain, 08023
Actively Recruiting
25
Hospital General Universitario Vall D Hebron
Barcelona, Spain, 08035
Actively Recruiting
26
Fundacion Jimenez Diaz University Hospital
Madrid, Spain, 28040
Actively Recruiting
27
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
28
Centro Integral Oncologico Clara Campal
Madrid, Spain, 28050
Actively Recruiting
29
Istituto Oncologico Della Svizzera Italiana
Bellinzona, Switzerland, 06500
Actively Recruiting
30
Centre Hospitalier Universitaire Vaudois (Chuv)
Lausanne, Switzerland, 01011
Actively Recruiting
31
Kantonsspital St. Gallen
Sankt Gallen, Switzerland, 09007
Actively Recruiting
32
Cambridge University Hospitals Nhs Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
33
Guys and St Thomas Nhs Foundation Trust
London, United Kingdom, SE1 9RT
Actively Recruiting
34
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
London, United Kingdom, W12 0HS
Actively Recruiting
35
The Christie Nhs Foundation Trust Uk
Manchester, United Kingdom, M20 4BV
Actively Recruiting
36
Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
Research Team
I
Incyte Corporation Call Center (US)
I
Incyte Corporation Call Center (ex-US)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
10
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