Trial Title:
A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors
NCT ID:
NCT05836324
Condition:
Solid Tumors
Advanced Solid Tumors
Metastatic Solid Tumors
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Solid Tumors
INCA33890
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
INCA33890
Description:
INCA33890 will be administered at protocol defined dose.
Arm group label:
Part 1a - Dose Escalation
Arm group label:
Part 1b-Dose Expansion
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- ≥18 years old
- Histologically or cytologically confirmed advanced or metastatic malignancies as
defined in the protocol.
- Participants must have experienced disease progression after treatment with
available therapies, including anti-PD-(L)1 or anti-CTLA4 therapy if applicable,
that are known to confer clinical benefit, or who are intolerant to, or ineligible
for standard treatment. Prior anti-PD-(L)1 therapy should not have been discontinued
because of intolerance.
- ECOG performance status score of 0 or 1.
- Willingness to undergo pre- and on-treatment tumor biopsy (core or excisional).
Biopsies are mandatory for Part 1b cohorts only.
- 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.
- Received more than 4 prior anticancer regimen(s) for advanced or metastatic disease.
- History of clinically significant or uncontrolled cardiac disease
- Active HBV (or at risk of activation), 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
- Participants with adequate laboratory values within the protocol defined ranges.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Angeles Clinic and Research Institute
Address:
City:
Los Angeles
Zip:
90025
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Cancer and Hematology Centers of Western Michigan-Start Midwest
Address:
City:
Grand Rapids
Zip:
49546
Country:
United States
Status:
Recruiting
Facility:
Name:
Hackensack University Medical Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Facility:
Name:
Lifespan Cancer Research Institute
Address:
City:
Providence
Zip:
02903
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Texas Md Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
South Texas Accelerated Research Therapeutics
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Facility:
Name:
Rigshospitalet Uni of Hospital of Copenhagen
Address:
City:
Copenhagen
Zip:
02100
Country:
Denmark
Status:
Recruiting
Facility:
Name:
Herlev Og Gentofte Hospital
Address:
City:
Herlev
Zip:
02730
Country:
Denmark
Status:
Recruiting
Facility:
Name:
Odense University Hospital
Address:
City:
Odense C
Zip:
05000
Country:
Denmark
Status:
Recruiting
Facility:
Name:
Vejle Hospital
Address:
City:
Vejle
Zip:
07100
Country:
Denmark
Status:
Recruiting
Facility:
Name:
Centre Leon Berard
Address:
City:
Lyon
Zip:
69373
Country:
France
Status:
Recruiting
Facility:
Name:
Institut Paoli Calmettes
Address:
City:
Marseille
Zip:
13009
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif Cedex
Zip:
94805
Country:
France
Status:
Recruiting
Facility:
Name:
Fondazione Irccs Istituto Nazionale Dei Tumori
Address:
City:
Milano
Zip:
20133
Country:
Italy
Status:
Recruiting
Facility:
Name:
Irccs Istituto Clinico Humanitas
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Status:
Recruiting
Facility:
Name:
Centro Ricerche Cliniche Di Verona
Address:
City:
Verona
Zip:
37134
Country:
Italy
Status:
Recruiting
Facility:
Name:
Start Barcelona
Address:
City:
Barcelona
Zip:
08023
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital General Universitario Vall D Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Fundacion Jimenez Diaz University Hospital
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Centro Integral Oncologico Clara Campal
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Facility:
Name:
Istituto Oncologico Della Svizzera Italiana
Address:
City:
Bellinzona
Zip:
06500
Country:
Switzerland
Status:
Recruiting
Facility:
Name:
Centre Hospitalier Universitaire Vaudois (Chuv)
Address:
City:
Lausanne
Zip:
01011
Country:
Switzerland
Status:
Recruiting
Facility:
Name:
Kantonsspital St. Gallen
Address:
City:
St. Gallen
Zip:
09007
Country:
Switzerland
Status:
Recruiting
Facility:
Name:
Cambridge University Hospitals Nhs Foundation Trust
Address:
City:
Cambridge
Zip:
CB2 0QQ
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Guys and St Thomas Nhs Foundation Trust
Address:
City:
London
Zip:
SE1 9RT
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
Address:
City:
London
Zip:
W12 0HS
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
The Christie Nhs Foundation Trust Uk
Address:
City:
Manchester
Zip:
M20 4BV
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust
Address:
City:
Newcastle Upon Tyne
Zip:
NE7 7DN
Country:
United Kingdom
Status:
Recruiting
Start date:
July 24, 2023
Completion date:
December 24, 2026
Lead sponsor:
Agency:
Incyte Corporation
Agency class:
Industry
Source:
Incyte Corporation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05836324
