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

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05836324
• Other study ID #: INCA 33890-101
• Status: Recruiting
• Phase: Phase 1
• Start date: July 24, 2023
• Est. completion date: December 24, 2026

Study information

• Verified date: March 2024
• Source: Incyte Corporation
• Contact: Incyte Corporation Call Center (US)
• Phone: 1.855.463.3463
• Email: medinfo[@]incyte.com
• Is FDA regulated: No
• 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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Metastatic Solid Tumors
• Neoplasms
• Solid Tumors

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