Clinical trial NCT05836324: A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors
Official title: A Phase 1, Open-Label, Multicenter Study of INCA33890 in Participants With Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumors
Advanced Solid Tumors
Metastatic Solid Tumors
Keywords: Solid Tumors
INCA33890
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2023-05-01
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Dose Limiting Toxicities (DLTs)
timeFrame: Up to 28 days
measure: Treatment Emerging Adverse Events (TEAEs)
timeFrame: Up to 2 years
measure: TEAEs leading to dose modification or discontinuation
timeFrame: Up to 2 years
Secondary outcomes:
measure: Objective response Rate
timeFrame: 2 years
measure: Disease Control Rate
timeFrame: 2 years
measure: Duration of Response
timeFrame: 2 years
measure: Pharmacokinetics Parameter : Cmax of INCA33890
timeFrame: 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
measure: Pharmacokinetics Parameter : Tmax of INCA33890
timeFrame: 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
measure: Pharmacokinetics Parameter : Cmin of INCA33890
timeFrame: 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
measure: Pharmacokinetics Parameter : AUC(0-t) of INCA33890
timeFrame: 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
measure: Pharmacokinetics Parameter : AUC 0-∞ of INCA33890
timeFrame: 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
measure: Pharmacokinetics Parameter : CL of INCA33890
timeFrame: 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
measure: Pharmacokinetics Parameter : Vz of INCA33890
timeFrame: 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
measure: Pharmacokinetics Parameter : t1/2 of INCA33890
timeFrame: 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
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institute
state: California
city: Los Angeles
country: United States
facility: Valkyrie Clinical Trials
state: California
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Grand Rapids
country: United States
facility: Cancer and Hematology Centers of Western Michigan-Start Midwest
state: Michigan
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Mineola
country: United States
facility: Nyu Langone Health - Long Island Hospital
state: New York
city: New York
country: United States
facility: Laura and Isaac Perlmutter Cancer Center
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Providence
country: United States
facility: Lifespan Cancer Research Institute
state: Rhode Island
city: Houston
country: United States
facility: University of Texas Md Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics
state: Texas
city: Copenhagen
country: Denmark
facility: Rigshospitalet Uni of Hospital of Copenhagen
city: Herlev
country: Denmark
facility: Herlev Og Gentofte Hospital
city: Odense C
country: Denmark
facility: Odense University Hospital
city: Vejle
country: Denmark
facility: Vejle Hospital
city: Lyon
country: France
facility: Centre Leon Berard
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy
city: Milano
country: Italy
facility: Fondazione Irccs Istituto Nazionale Dei Tumori
city: Rozzano
country: Italy
facility: Irccs Istituto Clinico Humanitas
city: Verona
country: Italy
facility: Centro Ricerche Cliniche Di Verona
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital of Jfcr
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Barcelona
country: Spain
facility: Start Barcelona
city: Barcelona
country: Spain
facility: Hospital General Universitario Vall D Hebron
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz University Hospital
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Centro Integral Oncologico Clara Campal
city: Bellinzona
country: Switzerland
facility: Istituto Oncologico Della Svizzera Italiana
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois (Chuv)
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals Nhs Foundation Trust
city: London
country: United Kingdom
facility: Guys and St Thomas Nhs Foundation Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare Nhs Trust - Hammersmith Hospital
city: Manchester
country: United Kingdom
facility: The Christie Nhs Foundation Trust Uk
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust
Study officials:
References: