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Solid TumorsPhase 1NCT05836324

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

A Phase 1 study testing INCA33890, bevacizumab and FOLFIRI in people with Solid Tumors and Advanced Solid Tumors, run by Incyte Corporation at 39 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
INCA33890, bevacizumab and FOLFIRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
570 participants
Where
39 sitesin 9 countries
Study dates
24 Jul 2023to 3 May 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

39 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Incyte Corporation Call Center (US) contact

1.855.463.3463

medinfo@incyte.com

Incyte Corporation Call Center (ex-US) contact

+800 00027423

eumedinfo@incyte.com

39 sites in 9 countries

United States11 sites, 11 recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Recruiting

  • Cancer and Hematology Centers of Western Michigan-Start Midwest

    Grand Rapids, Michigan, 49546

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Recruiting

  • University of Texas Md Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • The Angeles Clinic and Research Institute

    Los Angeles, California, 90025

    Recruiting

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067

    Recruiting

  • Nyu Langone Health - Long Island Hospital

    Mineola, New York, 11501

    Recruiting

  • Laura and Isaac Perlmutter Cancer Center

    New York, New York, 10016

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Lifespan Cancer Research Institute

    Providence, Rhode Island, 02903

    Recruiting

  • South Texas Accelerated Research Therapeutics

    San Antonio, Texas, 78229

    Recruiting

Other trials in United States

Spain5 sites, 5 recruiting

  • Start Barcelona

    Barcelona, 08023

    Recruiting

  • Hospital General Universitario Vall D Hebron

    Barcelona, 08035

    Recruiting

  • Fundacion Jimenez Diaz University Hospital

    Madrid, 28040

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Recruiting

  • Centro Integral Oncologico Clara Campal

    Madrid, 28050

    Recruiting

Other trials in Spain

United Kingdom5 sites, 5 recruiting

  • Cambridge University Hospitals Nhs Foundation Trust

    Cambridge, CB2 0QQ

    Recruiting

  • Guys and St Thomas Nhs Foundation Trust

    London, SE1 9RT

    Recruiting

  • Imperial College Healthcare Nhs Trust - Hammersmith Hospital

    London, W12 0HS

    Recruiting

  • The Christie Nhs Foundation Trust Uk

    Manchester, M20 4BV

    Recruiting

  • Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust

    Newcastle upon Tyne, NE7 7DN

    Recruiting

Other trials in United Kingdom

Denmark4 sites, 4 recruiting

  • Rigshospitalet Uni of Hospital of Copenhagen

    Copenhagen, 02100

    Recruiting

  • Herlev Og Gentofte Hospital

    Herlev, 02730

    Recruiting

  • Odense University Hospital

    Odense C, 05000

    Recruiting

  • Vejle Hospital

    Vejle, 07100

    Recruiting

Other trials in Denmark

China3 sites, 3 recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, 100021

    Not yet recruiting

  • Peking University People'S Hospital

    Beijing, 100044

    Not yet recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine (Fahzu)

    Hangzhou, 310003

    Not yet recruiting

Other trials in China

Italy3 sites, 3 recruiting

  • Fondazione Irccs Istituto Nazionale Dei Tumori

    Milan, 20133

    Recruiting

  • Irccs Istituto Clinico Humanitas

    Rozzano, 20089

    Recruiting

  • Centro Ricerche Cliniche Di Verona

    Verona, 37134

    Recruiting

Other trials in Italy

Japan3 sites, 3 recruiting

  • Kansai Medical University Hospital

    Hirakata, 573-1191

    Recruiting

  • National Cancer Center Hospital

    Tokyo, 104-0045

    Recruiting

  • The Cancer Institute Hospital of Jfcr

    Tokyo, 135-0063

    Recruiting

Other trials in Japan

Switzerland3 sites, 3 recruiting

  • Istituto Oncologico Della Svizzera Italiana

    Bellinzona, 06500

    Recruiting

  • Centre Hospitalier Universitaire Vaudois (Chuv)

    Lausanne, 01011

    Recruiting

  • Kantonsspital St. Gallen

    Sankt Gallen, 09007

    Recruiting

Other trials in Switzerland

France2 sites, 2 recruiting

  • Centre Leon Berard

    Lyon, 69373

    Recruiting

  • Institut Gustave Roussy

    Villejuif, 94805

    Recruiting

Other trials in France

About this study

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

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.

Being tested
INCA33890, bevacizumab, FOLFIRI, FOLFOX, Cetuximab
Keywords
Solid Tumors, INCA33890

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INCA33890Drug

    INCA33890 will be administered at protocol defined dose.

  • bevacizumabDrug

    Bevacizumab will be administered at protocol defined dose.

  • FOLFIRIDrug

    FOLFIRI will be administered at protocol defined dose.

  • FOLFOXDrug

    FOLFOX will be administered at protocol defined dose.

  • CetuximabDrug

    Cetuximab will be administered at protocol defined dose.

  • ADG126Drug

    ADG126 will be administered at protocol defined dose.

Study groups in NCT05836324
Study groupRoleWhat they receive
Part 1a - Dose Escalation MonotherapyExperimentalINCA33890 will be administered at the protocol-defined dose based on cohort assignment.
Receives: Drug: INCA33890
Part 1b-Dose Expansion MonotherapyExperimentalINCA33890 will be administered at the protocol-defined dose based on cohort assignment.
Receives: Drug: INCA33890
Part 2a - Dose Escalation Combination Therapy - Group 1ExperimentalINCA33890 will be administered in combination with bevacizumab at the protocol-defined dose based on cohort assignment.
Receives: Drug: INCA33890; Drug: bevacizumab
Part 2a - Dose Escalation Combination Therapy - Group 2ExperimentalINCA33890 will be administered in combination with bevacizumab and FOLFIRI at the protocol-defined dose based on cohort assignment.
Receives: Drug: INCA33890; Drug: bevacizumab; Drug: FOLFIRI
Part 2a - Dose Escalation Combination Therapy - Group 3ExperimentalINCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose based on cohort assignment.
Receives: Drug: INCA33890; Drug: bevacizumab; Drug: FOLFOX
Part 2a - Dose Escalation Combination Therapy - Group 4ExperimentalINCA33890 will be administered in combination with cetuximab at the protocol-defined dose based on cohort assignment.
Receives: Drug: INCA33890; Drug: Cetuximab
Part 2a - Dose Escalation Combination Therapy - Group 5ExperimentalINCA33890 will be administered in combination with ADG126 at the protocol-defined dose based on cohort assignment.
Receives: Drug: INCA33890; Drug: ADG126
Part 2b - Dose Expansion Combination Therapy - Group 1ExperimentalINCA33890 will be administered in combination with bevacizumab at the protocol-defined dose based on cohort assignment.
Receives: Drug: INCA33890; Drug: bevacizumab
Part 2b - Dose Expansion Combination Therapy - Group 2ExperimentalINCA33890 will be administered in combination with bevacizumab and FOLFIRI at the protocol-defined dose based on cohort assignment.
Receives: Drug: INCA33890; Drug: bevacizumab; Drug: FOLFIRI
Part 2b - Dose Expansion Combination Therapy - Group 3ExperimentalINCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose based on cohort assignment.
Receives: Drug: INCA33890; Drug: bevacizumab; Drug: FOLFOX
Part 2b - Dose Expansion Combination Therapy - Group 4ExperimentalINCA33890 will be administered in combination with cetuximab at the protocol-defined dose based on cohort assignment.
Receives: Drug: INCA33890; Drug: Cetuximab
Part 2b - Dose Expansion Combination Therapy - Group 5ExperimentalINCA33890 will be administered in combination with ADG126 at the protocol-defined dose based on cohort assignment.
Receives: Drug: INCA33890; Drug: ADG126

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicities (DLTs)

    Measured: Up to 28 days

  2. Treatment Emerging Adverse Events (TEAEs)

    Measured: Up to 2 years

  3. TEAEs leading to dose modification or discontinuation

    Measured: Up to 2 years

Secondary outcomes (11)

  1. Objective response Rate

    Measured: 2 years

  2. Disease Control Rate

    Measured: 2 years

  3. Duration of Response

    Measured: 2 years

  4. Pharmacokinetics Parameter : Cmax of INCA33890

    Measured: 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

  5. Pharmacokinetics Parameter : Tmax of INCA33890

    Measured: 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. Pharmacokinetics Parameter : Cmin of INCA33890

    Measured: 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

  7. Pharmacokinetics Parameter : AUC(0-t) of INCA33890

    Measured: 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

  8. Pharmacokinetics Parameter : AUC 0-∞ of INCA33890

    Measured: 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

  9. Pharmacokinetics Parameter : CL of INCA33890

    Measured: 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

  10. Pharmacokinetics Parameter : Vz of INCA33890

    Measured: 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

  11. Pharmacokinetics Parameter : t1/2 of INCA33890

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2023
  2. Study start24 Jul 2023
  3. Primary completion3 May 2029 (estimated)
  4. Study completion3 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
570 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05836324
Sponsor's protocol ID
INCA 33890-101
Other IDs
2022-502456-31-00
Status last verified
Jul 2026
First submitted
14 Apr 2023
Last updated
23 Jul 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing INCA33890, bevacizumab and FOLFIRI in people with Solid Tumors and Advanced Solid Tumors, run by Incyte Corporation at 39 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States, Spain, United Kingdom, Denmark, China and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Incyte Corporation Call Center (US) (1.855.463.3463, medinfo@incyte.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicities (DLTs) (time frame: Up to 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05836324.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.

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