A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors
A Phase 1, Open-Label, Multicenter Study of INCA33890 in Participants With Advanced or Metastatic Solid Tumors
2 other identifiers
interventional
408
8 countries
36
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2023
Typical duration for phase_1
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2023
CompletedFirst Posted
Study publicly available on registry
May 1, 2023
CompletedStudy Start
First participant enrolled
July 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 13, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 13, 2027
December 18, 2025
December 1, 2025
3.5 years
April 14, 2023
December 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Dose Limiting Toxicities (DLTs)
Up to 28 days
Treatment Emerging Adverse Events (TEAEs)
Up to 2 years
TEAEs leading to dose modification or discontinuation
Up to 2 years
Secondary Outcomes (11)
Objective response Rate
2 years
Disease Control Rate
2 years
Duration of Response
2 years
Pharmacokinetics Parameter : Cmax of INCA33890
Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up
Pharmacokinetics Parameter : Tmax of INCA33890
Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up
- +6 more secondary outcomes
Study Arms (10)
Part 1a - Dose Escalation Monotherapy
EXPERIMENTALINCA33890 will be administered at the protocol-defined dose based on cohort assignment.
Part 1b-Dose Expansion Monotherapy
EXPERIMENTALINCA33890 will be administered at the protocol-defined dose based on cohort assignment.
Part 2a - Dose Escalation Combination Therapy - Group 1
EXPERIMENTALINCA33890 will be administered in combination with bevacizumab at the protocol-defined dose based on cohort assignment.
Part 2a - Dose Escalation Combination Therapy - Group 2
EXPERIMENTALINCA33890 will be administered in combination with bevacizumab and FOLFIRI at the protocol-defined dose based on cohort assignment.
Part 2a - Dose Escalation Combination Therapy - Group 3
EXPERIMENTALINCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose based on cohort assignment.
Part 2a - Dose Escalation Combination Therapy - Group 4
EXPERIMENTALINCA33890 will be administered in combination with cetuximab at the protocol-defined dose based on cohort assignment.
Part 2b - Dose Expansion Combination Therapy - Group 1
EXPERIMENTALINCA33890 will be administered in combination with bevacizumab at the protocol-defined dose based on cohort assignment.
Part 2b - Dose Expansion Combination Therapy - Group 2
EXPERIMENTALINCA33890 will be administered in combination with bevacizumab and FOLFIRI at the protocol-defined dose based on cohort assignment.
Part 2b - Dose Expansion Combination Therapy - Group 3
EXPERIMENTALINCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose based on cohort assignment.
Part 2b - Dose Expansion Combination Therapy - Group 4
EXPERIMENTALINCA33890 will be administered in combination with cetuximab at the protocol-defined dose based on cohort assignment.
Interventions
INCA33890 will be administered at protocol defined dose.
Bevacizumab will be administered at protocol defined dose.
FOLFIRI will be administered at protocol defined dose.
FOLFOX will be administered at protocol defined dose.
Cetuximab will be administered at protocol defined dose.
Eligibility Criteria
You may qualify if:
- ≥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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
The Angeles Clinic and Research Institute
Los Angeles, California, 90025, United States
Valkyrie Clinical Trials
Los Angeles, California, 90067, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Cancer and Hematology Centers of Western Michigan-Start Midwest
Grand Rapids, Michigan, 49546, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Nyu Langone Health - Long Island Hospital
Mineola, New York, 11501, United States
Laura and Isaac Perlmutter Cancer Center
New York, New York, 10016, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Lifespan Cancer Research Institute
Providence, Rhode Island, 02903, United States
University of Texas Md Anderson Cancer Center
Houston, Texas, 77030, United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229, United States
Rigshospitalet Uni of Hospital of Copenhagen
Copenhagen, 02100, Denmark
Herlev Og Gentofte Hospital
Herlev, 02730, Denmark
Odense University Hospital
Odense C, 05000, Denmark
Vejle Hospital
Vejle, 07100, Denmark
Centre Leon Berard
Lyon, 69373, France
Institut Gustave Roussy
Villejuif, 94805, France
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan, 20133, Italy
Irccs Istituto Clinico Humanitas
Rozzano, 20089, Italy
Centro Ricerche Cliniche Di Verona
Verona, 37134, Italy
Kansai Medical University Hospital
Hirakata, 573-1191, Japan
National Cancer Center Hospital
Tokyo, 104-0045, Japan
The Cancer Institute Hospital of Jfcr
Tokyo, 135-0063, Japan
Start Barcelona
Barcelona, 08023, Spain
Hospital General Universitario Vall D Hebron
Barcelona, 08035, Spain
Fundacion Jimenez Diaz University Hospital
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Centro Integral Oncologico Clara Campal
Madrid, 28050, Spain
Istituto Oncologico Della Svizzera Italiana
Bellinzona, 06500, Switzerland
Centre Hospitalier Universitaire Vaudois (Chuv)
Lausanne, 01011, Switzerland
Kantonsspital St. Gallen
Sankt Gallen, 09007, Switzerland
Cambridge University Hospitals Nhs Foundation Trust
Cambridge, CB2 0QQ, United Kingdom
Guys and St Thomas Nhs Foundation Trust
London, SE1 9RT, United Kingdom
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
London, W12 0HS, United Kingdom
The Christie Nhs Foundation Trust Uk
Manchester, M20 4BV, United Kingdom
Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust
Newcastle upon Tyne, NE7 7DN, United Kingdom
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2023
First Posted
May 1, 2023
Study Start
July 24, 2023
Primary Completion (Estimated)
January 13, 2027
Study Completion (Estimated)
January 13, 2027
Last Updated
December 18, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
- Access Criteria
- Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency