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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT05836324

Studienbeginn:
Juli 2023

Letztes Update:
01.04.2024

Wirkstoff:
INCA33890

Indikation (Clinical Trials):
Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Incyte Corporation

Collaborator:
-

Kontakt

Studienlocations
(3 von 30)

The Angeles Clinic and Research Institute
90025 Los Angeles
United StatesRekrutierend» Google-Maps
Dana Farber Cancer Institute
02215 Boston
United StatesNoch nicht rekrutierend» Google-Maps
Cancer and Hematology Centers of Western Michigan-Start Midwest
49546 Grand Rapids
United StatesRekrutierend» Google-Maps
Hackensack University Medical Center
07601 Hackensack
United StatesRekrutierend» Google-Maps
Lifespan Cancer Research Institute
02903 Providence
United StatesRekrutierend» Google-Maps
University of Texas Md Anderson Cancer Center
77030 Houston
United StatesRekrutierend» Google-Maps
South Texas Accelerated Research Therapeutics
78229 San Antonio
United StatesRekrutierend» Google-Maps
Rigshospitalet Uni of Hospital of Copenhagen
02100 Copenhagen
DenmarkRekrutierend» Google-Maps
Institut Paoli Calmettes
13009 Marseille
FranceNoch nicht rekrutierend» Google-Maps
Institut Gustave Roussy
94805 Villejuif Cedex
FranceNoch nicht rekrutierend» Google-Maps
Fondazione Irccs Istituto Nazionale Del Tumori Di Milano
20133 Milano
ItalyRekrutierend» Google-Maps
Irccs Istituto Clinico Humanitas
20089 Rozzano
ItalyRekrutierend» Google-Maps
Centro Ricerche Cliniche Di Verona (Crc)
37134 Verona
ItalyRekrutierend» Google-Maps
Hospital General Universitario Vall D Hebron
08035 Barcelona
SpainRekrutierend» Google-Maps
Fundacion Jimenez Diaz University Hospital
28040 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario 12 de Octubre
28041 Madrid
SpainRekrutierend» Google-Maps
Centro Integral Oncologico Clara Campal
28050 Madrid
SpainRekrutierend» Google-Maps
Istituto Oncologico Della Svizzera Italiana
06500 Bellinzona
SwitzerlandRekrutierend» Google-Maps
Centre Hospitalier Universitaire Vaudois (Chuv)
01011 Lausanne
SwitzerlandRekrutierend» Google-Maps
Kantonsspital St. Gallen
09007 St. Gallen
SwitzerlandRekrutierend» Google-Maps
Cambridge University Hospitals Nhs Foundation Trust
CB2 0QQ Cambridge
United KingdomRekrutierend» Google-Maps
Guys and St Thomas Nhs Foundation Trust
SE1 9RT London
United KingdomNoch nicht rekrutierend» Google-Maps
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
W12 0HS London
United KingdomRekrutierend» Google-Maps
The Christie Nhs Foundation Trust Uk
M20 4BV Manchester
United KingdomNoch nicht rekrutierend» Google-Maps
Freeman Hospital Newcastle Upon Tyne Foundation Nhs Trust
NE7 7DN Newcastle Upon Tyne
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. Number of participants with Dose Limiting Toxicities (DLTs) (Time Frame - Up to 28 days)

2. Number of participants with Treatment Emerging Adverse Events (TEAEs) (Time Frame - Up to 2 years)

3. Number of participants with TEAEs leading to dose modification or discontinuation (Time Frame - Up to 2 years)

Secondary outcome:

1. Objective response Rate (Time Frame - 2 years)

2. Disease Control Rate (Time Frame - 2 years)

3. Duration of Response (Time Frame - 2 years)

4. Pharmacokinetics Parameter : Cmax of INCA33890 (Time Frame - 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 (Time Frame - 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 (Time Frame - 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 (Time Frame - 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 (Time Frame - 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/F of INCA33890 (Time Frame - 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/F of INCA33890 (Time Frame - 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 (Time Frame - 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)

Studien-Arme

  • Experimental: Part 1a - Dose Escalation
    INCA33890 will be administered at a protocol defined starting regimen intravenously. Subsequent dose regimens will be determined during study conduct.
  • Experimental: Part 1b-Dose Expansion
    INCA33890 will be administered at the recommended dose(s) for expansion (RDE[s]) in participants with advanced or metastatic ICI sensitive or ICI non sensitive tumor types

Geprüfte Regime

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

Quelle: ClinicalTrials.gov


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