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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05836324
Other study ID # INCA 33890-101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date July 24, 2023
Est. completion date December 24, 2026

Study information

Verified date June 2024
Source Incyte Corporation
Contact Incyte Corporation Call Center (US)
Phone 1.855.463.3463
Email medinfo@incyte.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 165
Est. completion date December 24, 2026
Est. primary completion date December 24, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - =18 years old - Histologically or cytologically confirmed advanced or metastatic malignancies - 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.

Study Design


Intervention

Drug:
INCA33890
INCA33890 will be administered at protocol defined dose.

Locations

Country Name City State
Denmark Rigshospitalet Uni of Hospital of Copenhagen Copenhagen
Denmark Herlev Og Gentofte Hospital Herlev
Denmark Odense University Hospital Odense C
Denmark Vejle Hospital Vejle
France Centre Leon Berard Lyon
France Institut Paoli Calmettes Marseille
France Institut Gustave Roussy Villejuif Cedex
Italy Fondazione Irccs Istituto Nazionale Del Tumori Di Milano Milano
Italy Irccs Istituto Clinico Humanitas Rozzano
Italy Centro Ricerche Cliniche Di Verona (Crc) Verona
Spain Hospital General Universitario Vall D Hebron Barcelona
Spain Start Barcelona Barcelona
Spain Centro Integral Oncologico Clara Campal Madrid
Spain Fundacion Jimenez Diaz University Hospital Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Switzerland Istituto Oncologico Della Svizzera Italiana Bellinzona
Switzerland Centre Hospitalier Universitaire Vaudois (Chuv) Lausanne
Switzerland Kantonsspital St. Gallen St. Gallen
United Kingdom Cambridge University Hospitals Nhs Foundation Trust Cambridge
United Kingdom Guys and St Thomas Nhs Foundation Trust London
United Kingdom Imperial College Healthcare Nhs Trust - Hammersmith Hospital London
United Kingdom The Christie Nhs Foundation Trust Uk Manchester
United Kingdom Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust Newcastle Upon Tyne
United States Dana Farber Cancer Institute Boston Massachusetts
United States Cancer and Hematology Centers of Western Michigan-Start Midwest Grand Rapids Michigan
United States Hackensack University Medical Center Hackensack New Jersey
United States University of Texas Md Anderson Cancer Center Houston Texas
United States The Angeles Clinic and Research Institute Los Angeles California
United States Lifespan Cancer Research Institute Providence Rhode Island
United States South Texas Accelerated Research Therapeutics San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Denmark,  France,  Italy,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with Dose Limiting Toxicities (DLTs) Up to 28 days
Primary Number of participants with Treatment Emerging Adverse Events (TEAEs) Up to 2 years
Primary Number of participants with TEAEs leading to dose modification or discontinuation Up to 2 years
Secondary Objective response Rate 2 years
Secondary Disease Control Rate 2 years
Secondary Duration of Response 2 years
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Pharmacokinetics Parameter : AUC 0-8 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
Secondary Pharmacokinetics Parameter : CL/F 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
Secondary Pharmacokinetics Parameter : Vz/F 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
Secondary 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
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