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JOURNAL ONKOLOGIE – STUDIE

ZN-c3 in Adult Participants With Metastatic Colorectal Cancer

Rekrutierend

NCT-Nummer:
NCT05743036

Studienbeginn:
Februar 2023

Letztes Update:
08.03.2024

Wirkstoff:
ZN-c3, Encorafenib, Cetuximab

Indikation (Clinical Trials):
Colorectal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

Collaborator:
Pfizer

Kontakt

K-Group Beta, Inc. a subsidiary of Zentalis Pharmaceuticals
Kontakt:
Phone: (212) 433-3791
E-Mail: info@zenopharma.com» Kontaktdaten anzeigen

Studienlocations
(3 von 27)

Hämatologie- Onkologie im Zentrum MVZ GmbH
86150 Augsburg
(Bayern)
GermanyRekrutierend» Google-Maps
Klinikum der Universität München Großhadern
81377 Muenchen
(Bayern)
GermanyRekrutierend» Google-Maps
Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie
81737 Muenchen
(Bayern)
GermanyRekrutierend» Google-Maps
Institut für Klinisch Onkologische Forschung
60488 Frankfurt
(Hessen)
GermanyRekrutierend» Google-Maps
DRK Kliniken Berlin - Köpenick
12559 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
USC Norris Comprehensive Cancer Center
90033 Los Angeles
United StatesRekrutierend» Google-Maps
Alliance for Multispecialty Research, LLC
66204 Merriam
United StatesRekrutierend» Google-Maps
University of Texas MD Anderson Cancer Center
77030 Houston
United StatesRekrutierend» Google-Maps
The Queen Elizabeth Hospital
5011 Woodville South
AustraliaRekrutierend» Google-Maps
Peter MacCallum Cancer Centre
3000 Melbourne
AustraliaRekrutierend» Google-Maps
Semmelweis University-Department of Internal Medicine and Oncology
1083 Budapest
HungaryRekrutierend» Google-Maps
Clinexpert Kft. Bugat Pal Korhaz
3200 Gyöngyös
HungaryRekrutierend» Google-Maps
Istituto Nazionale Tumori IRCCS Fondazione Pascale
80131 Napoli
ItalyRekrutierend» Google-Maps
IRCCS Casa Sollievo della Sofferenza
71013 San Giovanni Rotondo
ItalyRekrutierend» Google-Maps
ASST Grande Ospedale Metropolitano Niguarda
20162 Milano
ItalyRekrutierend» Google-Maps
Szpital Uniwersytecki w Krakowie
31-501 Kraków
PolandRekrutierend» Google-Maps
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
31-826 Kraków
PolandRekrutierend» Google-Maps
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
02-034 Warsaw
PolandRekrutierend» Google-Maps
Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego
45-061 Opole
PolandRekrutierend» Google-Maps
Parc de Salut Mar - Hospital del Mar
08003 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitario Reina Sofia
14004 Córdoba
SpainRekrutierend» Google-Maps
Fundación Instituto Valenciano de Oncología
46009 Valencia
SpainRekrutierend» Google-Maps
Hospital Universitari Vall d'Hebron
08035 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitario Puerta de Hierro Majadahonda
28222 Madrid
SpainRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of this study is to evaluate the safety, tolerability, and potential clinical

benefits of ZN-c3 administered in combination with encorafenib and cetuximab in adult

participants with metastatic BRAF V600E mutant colorectal cancer previously treated with one

or two treatment regimens.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Histologically or cytologically confirmed metastatic Stage IV colorectal

adenocarcinoma.

- Documented evidence of a BRAF V600E mutation in tumor tissue or blood

- Presence of measurable disease per RECIST version 1.1 guidelines.

- Disease progression after 1 or 2 previous systemic regimens for metastatic disease

- Adequate bone marrow function

- Adequate hepatic and renal function

Exclusion Criteria:

- Documented clinical disease progression or radiographic disease progression during the

screening period

- Leptomeningeal disease.

- Symptomatic brain metastasis.

- Presence of acute or chronic pancreatitis.

- Unable to swallow, retain, and absorb oral medications.

- Clinically significant cardiovascular diseases

- Evidence of active noninfectious pneumonitis.

- Evidence of active and uncontrolled bacterial or viral infection, within 2 weeks prior

to start of any of the study interventions

- Participants with known positivity for HIV

- Active hepatitis B or hepatitis C infection

- Concurrent or previous other malignancy within 2 years of study entry

- Has had an allogeneic tissue/solid organ transplant

- Pregnant or females of childbearing potential who have a positive β-hCG laboratory

test result within 14 days prior to enrollment or is breastfeeding

Studien-Rationale

Primary outcome:

1. Dose Escalation Phase - Incidence of Dose Limiting Toxicities (DLTs) (Time Frame - From Lead-in Day -1 to Cycle 1 Day 28):
DLTs defined as treatment-related AEs occurring within the first 29 days after the start of any study treatment that in the opinion of the investigator cannot be reasonably attributed to the participant's underlying disease, concomitant medications, or pre-existing conditions.

2. Dose Expansion Phase - Objective response rate (ORR) (Time Frame - From first dose of any study intervention every 8 weeks during treatment, up to 12 months):
ORR defined as the proportion of participants who achieves a best overall response of Complete Response (CR) or Partial Response (PR), assessed by Investigator per RECIST Version 1.1.

Secondary outcome:

1. Dose Escalation Phase - Incidence and severity of adverse events (AEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 (Time Frame - From first dose of any study intervention through 28 days after the last dose of any study intervention):
Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.

2. Proportion of participants with dose interruptions due to AEs in Dose Escalation Phase (Time Frame - From first dose of any study intervention through 28 days after the last dose of any study intervention)

3. Proportion of participants with dose modifications due to AEs in Dose Escalation Phase (Time Frame - From first dose of any study intervention through 28 days after the last dose of any study intervention)

4. Proportion of participants with discontinuations due to AEs in Dose Escalation Phase (Time Frame - From first dose of any study intervention through 28 days after the last dose of any study intervention)

5. Dose Escalation Phase - Objective response rate (ORR) (Time Frame - From first dose of any study intervention every 8 weeks during treatment, up to 12 months):
ORR defined as the proportion of participants who achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) per RECIST Version 1.1.

6. Dose Escalation Phase - Duration of Response (DOR) (Time Frame - From first dose of any study intervention every 8 weeks during treatment, up to 12 months):
DOR defined as the time from the date of first radiographic evidence of response (CR or PR) to the earliest documented disease progression per RECIST version 1.1, or death due to any cause.

7. Dose Escalation Phase - Progression Free Survival (PFS) (Time Frame - From first dose of any study intervention every 8 weeks during treatment, up to 12 months):
PFS defined as the time from the first dose to the earliest documented disease progression per RECIST version 1.1, or death due to any cause.

8. Dose Escalation Phase - Disease Control Rate (DCR) (Time Frame - From first dose of any study intervention every 8 weeks during treatment, up to 12 months):
DCR defined as the proportion of participants with BOR of CR, PR, or stable disease (SD), per RECIST version 1.1.

9. Dose Escalation Phase - Time to Response (TTR) (Time Frame - From first dose of any study intervention every 8 weeks during treatment, up to 12 months):
TTR defined as the time from first dose to first radiographic evidence of response (CR or PR) per RECIST version 1.1.

10. Dose Escalation - ZN-c3 plasma exposure: AUC (Time Frame - From lead in day -1 visit through Cycle 1 Day 15)

11. Dose Escalation - ZN-c3 plasma exposure: Cmax (Time Frame - From lead in day -1 visit through Cycle 1 Day 15)

12. Dose Escalation - ZN-c3 plasma exposure: Tmax (Time Frame - From lead in day -1 visit through Cycle 1 Day 15)

13. Dose Escalation - Encorafenib plasma exposure: AUC (Time Frame - From lead in day -1 visit through Cycle 1 Day 15)

14. Dose Escalation - Encorafenib plasma exposure: Cmax (Time Frame - From lead in day -1 visit through Cycle 1 Day 15)

15. Dose Escalation - Encorafenib plasma exposure: Tmax (Time Frame - From lead in day -1 visit through Cycle 1 Day 15)

16. Dose Expansion Phase - Duration of Response (DOR) (Time Frame - From first dose of any study intervention every 8 weeks during treatment, up to 12 months):
DOR defined as the time from the date of first radiographic evidence of response (CR or PR) to the earliest documented disease progression per RECIST version 1.1, or death due to any cause.

17. Dose Expansion Phase - Progression Free Survival (PFS) (Time Frame - From first dose of any study intervention every 8 weeks during treatment, up to 12 months):
PFS defined as the time from the first dose to the earliest documented disease progression per RECIST version 1.1, or death due to any cause.

18. Dose Expansion Phase - Disease Control Rate (DCR) (Time Frame - From first dose of any study intervention every 8 weeks during treatment, up to 12 months):
DCR defined as the proportion of participants with BOR of CR, PR, or stable disease (SD), per RECIST version 1.1.

19. Dose Expansion Phase - Time to Response (TTR) (Time Frame - From first dose of any study intervention every 8 weeks during treatment, up to 12 months):
TTR defined as the time from first dose to first radiographic evidence of response (CR or PR) per RECIST version 1.1.

20. Dose Expansion Phase - Incidence and severity of adverse events (AEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 (Time Frame - From first dose of any study intervention through 28 days after the last dose of any study intervention):
Safety will be assessed by monitoring adverse events and clinically relevant changes in vital signs and clinical laboratory results.

21. Proportion of participants with dose interruptions due to AEs in Dose Expansion Phase (Time Frame - From first dose of any study intervention through 28 days after the last dose of any study intervention)

22. Proportion of participants with dose modifications due to AEs in Dose Expansion Phase (Time Frame - From first dose of any study intervention through 28 days after the last dose of any study intervention)

23. Proportion of participants with discontinuations due to AEs in Dose Expansion Phase (Time Frame - From first dose of any study intervention through 28 days after the last dose of any study intervention)

24. Dose Expansion - ZN-c3 in combination with combination with E+C plasma exposure: AUC (Time Frame - Lead in day 7)

25. Dose Expansion - ZN-c3 in combination with combination with E+C plasma exposure: Cmax (Time Frame - Lead in day 7)

26. Dose Expansion - ZN-c3 in combination with combination with E+C plasma exposure: Tmax (Time Frame - Day 7)

27. Dose Expansion - Encorafenib in combination with ZN-c3 and cetuximab plasma exposure: AUC (Time Frame - Cycle 1 Day 15)

28. Dose Expansion - Encorafenib in combination with ZN-c3 and cetuximab plasma exposure: Cmax (Time Frame - Cycle 1 Day 15)

29. Dose Expansion - Encorafenib in combination with ZN-c3 and cetuximab plasma exposure: Tmax (Time Frame - Cycle 1 Day 15)

30. Dose Expansion - ZN-c3 plasma exposure: AUC (Time Frame - Cycle 1 Day 15)

31. Dose Expansion - ZN-c3 plasma exposure: Cmax (Time Frame - Cycle 1 Day 15)

32. Tumor tissue BRAF V600E mutational status (Time Frame - From lead in day 1 visit through the last dose of any study intervention, up to 12 months)

Studien-Arme

  • Experimental: Dose Escalation
    Participants will receive different doses of ZN-c3 in combination with different doses of Encorafenib and a fixed dose of Cetuximab
  • Experimental: Dose Expansion
    Participants will receive recommended dose of ZN-c3 and encorafenib as determined in dose escalation phase in combination with cetuximab

Geprüfte Regime

  • ZN-c3:
    ZN-c3 tablet by mouth, in combination with encorafenib
  • Encorafenib (BRAFTOVI®):
    Encorafenib capsule by mouth, in combination with ZN-c3
  • Cetuximab (ERBITUX®):
    Infusion

Quelle: ClinicalTrials.gov


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