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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors; Solid Tumors; Metastatic Solid Tumors
• Intervention / Treatment: Drug: INCA33890; Drug: Cetuximab; Drug: bevacizumab; Drug: FOLFIRI; Drug: FOLFOX; Drug: ADG126

• Study Type: Interventional
• Enrollment (Estimated): 570
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Incyte Corporation Call Center (US); Phone Number: 1.855.463.3463; Email: medinfo@incyte.com
• Study Contact Backup: Name: Incyte Corporation Call Center (ex-US); Phone Number: +800 00027423; Email: eumedinfo@incyte.com

Study Locations

• China
  • Beijing, China, 100044
    • Not yet recruiting
    • Peking University People's Hospital
  • Beijing, China, 100021
    • Not yet recruiting
    • Cancer Hospital Chinese Academy of Medical Sciences
  • Hangzhou, China, 310003
    • Not yet recruiting
    • The First Affiliated Hospital, Zhejiang University School of Medicine (Fahzu)
• Denmark
  • Copenhagen, Denmark, 02100
    • Recruiting
    • Rigshospitalet Uni of Hospital of Copenhagen
  • Herlev, Denmark, 02730
    • Recruiting
    • Herlev Og Gentofte Hospital
  • Odense C, Denmark, 05000
    • Recruiting
    • Odense University Hospital
  • Vejle, Denmark, 07100
    • Recruiting
    • Vejle Hospital
• France
  • Lyon, France, 69373
    • Recruiting
    • Centre Leon Berard
  • Villejuif, France, 94805
    • Recruiting
    • Institut Gustave Roussy
• Italy
  • Milan, Italy, 20133
    • Recruiting
    • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Rozzano, Italy, 20089
    • Recruiting
    • IRCCS Istituto Clinico Humanitas
  • Verona, Italy, 37134
    • Recruiting
    • Centro Ricerche Cliniche Di Verona
• Japan
  • Hirakata, Japan, 573-1191
    • Recruiting
    • Kansai Medical University Hospital
  • Tokyo, Japan, 104-0045
    • Recruiting
    • National Cancer Center Hospital
  • Tokyo, Japan, 135-0063
    • Recruiting
    • The Cancer Institute Hospital of JFCR
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital General Universitario Vall D Hebron
  • Barcelona, Spain, 08023
    • Recruiting
    • Start Barcelona
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28050
    • Recruiting
    • Centro Integral Oncologico Clara Campal
  • Madrid, Spain, 28040
    • Recruiting
    • Fundacion Jimenez Diaz University Hospital
• Switzerland
  • Bellinzona, Switzerland, 06500
    • Recruiting
    • Istituto Oncologico della Svizzera Italiana
  • Lausanne, Switzerland, 01011
    • Recruiting
    • Centre Hospitalier Universitaire Vaudois (CHUV)
  • Sankt Gallen, Switzerland, 09007
    • Recruiting
    • Kantonsspital St. Gallen
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Recruiting
    • Cambridge University Hospitals NHS Foundation Trust
  • London, United Kingdom, W12 0HS
    • Recruiting
    • Imperial College Healthcare NHS Trust - Hammersmith Hospital
  • London, United Kingdom, SE1 9RT
    • Recruiting
    • Guys and St Thomas NHS Foundation Trust
  • Manchester, United Kingdom, M20 4BV
    • Recruiting
    • The Christie Nhs Foundation Trust Uk
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Recruiting
    • Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust
• United States
  • California
    • Los Angeles, California, United States, 90025
      • Recruiting
      • The Angeles Clinic and Research Institute
    • Los Angeles, California, United States, 90067
      • Recruiting
      • Valkyrie Clinical Trials
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana Farber Cancer Institute
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Recruiting
      • Cancer and Hematology Centers of Western Michigan-Start Midwest
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Recruiting
      • Hackensack University Medical Center
  • New York
    • Mineola, New York, United States, 11501
      • Recruiting
      • Nyu Langone Health - Long Island Hospital
    • New York, New York, United States, 10016
      • Recruiting
      • Laura and Isaac Perlmutter Cancer Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Lifespan Cancer Research Institute
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas MD Anderson Cancer Center
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • South Texas Accelerated Research Therapeutics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1a - Dose Escalation Monotherapy; INCA33890 will be administered at the protocol-defined dose based on cohort assignment.	Drug: INCA33890; INCA33890 will be administered at protocol defined dose.
Experimental: Part 1b-Dose Expansion Monotherapy; INCA33890 will be administered at the protocol-defined dose based on cohort assignment.	Drug: INCA33890; INCA33890 will be administered at protocol defined dose.
Experimental: Part 2a - Dose Escalation Combination Therapy - Group 1; INCA33890 will be administered in combination with bevacizumab at the protocol-defined dose based on cohort assignment.	Drug: INCA33890; INCA33890 will be administered at protocol defined dose.; Drug: bevacizumab; Bevacizumab will be administered at protocol defined dose.
Experimental: Part 2a - Dose Escalation Combination Therapy - Group 2; INCA33890 will be administered in combination with bevacizumab and FOLFIRI at the protocol-defined dose based on cohort assignment.	Drug: INCA33890; INCA33890 will be administered at protocol defined dose.; Drug: bevacizumab; Bevacizumab will be administered at protocol defined dose.; Drug: FOLFIRI; FOLFIRI will be administered at protocol defined dose.
Experimental: Part 2a - Dose Escalation Combination Therapy - Group 3; INCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose based on cohort assignment.	Drug: INCA33890; INCA33890 will be administered at protocol defined dose.; Drug: bevacizumab; Bevacizumab will be administered at protocol defined dose.; Drug: FOLFOX; FOLFOX will be administered at protocol defined dose.
Experimental: Part 2a - Dose Escalation Combination Therapy - Group 4; INCA33890 will be administered in combination with cetuximab at the protocol-defined dose based on cohort assignment.	Drug: INCA33890; INCA33890 will be administered at protocol defined dose.; Drug: Cetuximab; Cetuximab will be administered at protocol defined dose.
Experimental: Part 2b - Dose Expansion Combination Therapy - Group 1; INCA33890 will be administered in combination with bevacizumab at the protocol-defined dose based on cohort assignment.	Drug: INCA33890; INCA33890 will be administered at protocol defined dose.; Drug: bevacizumab; Bevacizumab will be administered at protocol defined dose.
Experimental: Part 2b - Dose Expansion Combination Therapy - Group 2; INCA33890 will be administered in combination with bevacizumab and FOLFIRI at the protocol-defined dose based on cohort assignment.	Drug: INCA33890; INCA33890 will be administered at protocol defined dose.; Drug: bevacizumab; Bevacizumab will be administered at protocol defined dose.; Drug: FOLFIRI; FOLFIRI will be administered at protocol defined dose.
Experimental: Part 2b - Dose Expansion Combination Therapy - Group 3; INCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose based on cohort assignment.	Drug: INCA33890; INCA33890 will be administered at protocol defined dose.; Drug: bevacizumab; Bevacizumab will be administered at protocol defined dose.; Drug: FOLFOX; FOLFOX will be administered at protocol defined dose.
Experimental: Part 2b - Dose Expansion Combination Therapy - Group 4; INCA33890 will be administered in combination with cetuximab at the protocol-defined dose based on cohort assignment.	Drug: INCA33890; INCA33890 will be administered at protocol defined dose.; Drug: Cetuximab; Cetuximab will be administered at protocol defined dose.
Experimental: Part 2a - Dose Escalation Combination Therapy - Group 5; INCA33890 will be administered in combination with ADG126 at the protocol-defined dose based on cohort assignment.	Drug: INCA33890; INCA33890 will be administered at protocol defined dose.; Drug: ADG126; ADG126 will be administered at protocol defined dose.
Experimental: Part 2b - Dose Expansion Combination Therapy - Group 5; INCA33890 will be administered in combination with ADG126 at the protocol-defined dose based on cohort assignment.	Drug: INCA33890; INCA33890 will be administered at protocol defined dose.; Drug: ADG126; ADG126 will be administered at protocol defined dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Duration of Response	2 years
Disease Control Rate	2 years
Objective response Rate	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
Pharmacokinetics Parameter : Cmin 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 : AUC(0-t) 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 : AUC 0-∞ 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 : t1/2 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 : CL 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 : Vz 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

Collaborators and Investigators

• Sponsor: Incyte Corporation

Publications and helpful links

Helpful Links

• A study to evaluate the safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2023
• Primary Completion (Estimated): May 3, 2029
• Study Completion (Estimated): May 3, 2029

Study Registration Dates

• First Submitted: April 14, 2023
• First Submitted That Met QC Criteria: April 26, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Solid Tumors; INCA33890
• Additional Relevant MeSH Terms: Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Bevacizumab; Cetuximab; Folfox protocol; IFL protocol
• Other Study ID Numbers: INCA 33890-101; 2022-502456-31-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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

• IPD Sharing Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No