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JOURNAL ONKOLOGIE – STUDIE
DeFianCe

Phase 2 Study of DKN-01 in Colorectal Cancer

Rekrutierend

NCT-Nummer:
NCT05480306

Studienbeginn:
August 2022

Letztes Update:
23.04.2024

Wirkstoff:
DKN-01, FOLFIRI, Bevacizumab, FOLFOX

Indikation (Clinical Trials):
Colorectal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Leap Therapeutics, Inc.

Collaborator:
-

Studienleiter

Cynthia Sirard, MD
Study Director
Leap Therapeutics, Inc.

Kontakt

Studienlocations
(3 von 41)

Universitaetsklinikum Hamburg-Eppendorf (UKE) - Universitaeres Cancer Center Hamburg (UCCH)
Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Heidelberg (UKHD) - Nationales Centrum fuer Tumorerkrankungen Heidelberg (NCT)
Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
SLK-Kliniken Heilbronn GmbH - Klinikum am Gesundbrunnen - Klinik fuer Innere Medizin III
Heilbronn
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Gemeinschaftspraxis fuer Haematologie und Onkologie - Magdeburg
Magdeburg
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz
(Rheinland-Pfalz)
GermanyRekrutierend» Google-Maps
The University of Arizona Cancer Center
85719 Tucson
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists & Research Institute (FCS)
33909 Cape Coral
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists & Research Institute
32003 Fleming Island
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists & Research Institute
32605 Gainesville
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists & Research Institute
33414 Wellington
United StatesRekrutierend» Google-Maps
Hematology Oncology of Indiana, PC - Indianapolis
46260 Indianapolis
United StatesRekrutierend» Google-Maps
Hematology Oncology Clinic
70809 Baton Rouge
United StatesRekrutierend» Google-Maps
Center for Cancer and Blood Disorders
20817 Bethesda
United StatesRekrutierend» Google-Maps
Oncology Hematology Associates - Springfield
65807 Springfield
United StatesRekrutierend» Google-Maps
Mount Sinai Medical Center - New York
10029 New York
United StatesRekrutierend» Google-Maps
White Plains Hospital
10601 White Plains
United StatesRekrutierend» Google-Maps
Messino Cancer Centers
28806 Asheville
United StatesRekrutierend» Google-Maps
Duke University Medical Center
27710 Durham
United StatesRekrutierend» Google-Maps
Wake Forest University
27157 Winston-Salem
United StatesRekrutierend» Google-Maps
Prisma Health Cancer Institute - Faris
29605 Greenville
United StatesRekrutierend» Google-Maps
Sanford Cancer Center
57104 Sioux Falls
United StatesRekrutierend» Google-Maps
Tennessee Oncology
37404 Chattanooga
United StatesRekrutierend» Google-Maps
SCRI Oncology Partners
37203 Nashville
United StatesNoch nicht rekrutierend» Google-Maps
MultiCare Tacoma General Hospital
98405 Tacoma
United StatesRekrutierend» Google-Maps
University of Wisconsin Hospital and Clinics
53792 Madison
United StatesRekrutierend» Google-Maps
Dong-A University Medical Center
Busan
Korea, Republic ofRekrutierend» Google-Maps
Kyungpook National University Chilgok Hospital
Daegu
Korea, Republic ofRekrutierend» Google-Maps
Gachon University Gil Medical Center
Incheon
Korea, Republic ofRekrutierend» Google-Maps
Inha University Hospital
Incheon
Korea, Republic ofRekrutierend» Google-Maps
CHA University - Bundang CHA General Hospital
Seongnam-si
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Bundang Hospital
Seongnam-si
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Hospital
Seoul
Korea, Republic ofRekrutierend» Google-Maps
The Catholic University of Korea - St. Vincent's Hospital
Suwon
Korea, Republic ofRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

This is a Phase 2 randomized, open-label, two-part, multicenter study with a safety run-in to

evaluate efficacy and safety of DKN-01 plus FOLFIRI/FOLFOX and bevacizumab versus standard of

care (SOC) [FOLFIRI/FOLFOX and bevacizumab] as second-line treatment of advanced CRC

patients.

In Parts A and B, approximately 150 evaluable adult advanced CRC patients with measurable

disease (RECIST v1.1) who have radiographically progressed during or following 1 line of

systemic treatment will be enrolled in the study.

The study consists of a Screening Period, a Treatment Period, a Safety Follow-up Period

(SFUP) and a Long-Term Follow-up Period (LTFU). Patients will be followed in the SFUP for

approximately 30 days (+7 days) after the last administration of study drug and then enter

the LTFU period to be followed for survival and subsequent therapies. Additionally, patients

that ended study treatment for a reason unrelated to progressive disease [PD] will also be

followed for disease progression in the LTFU period.

Ein-/Ausschlusskriterien

Adult patients with advanced CRC with measurable disease (RECIST v1.1) who have

radiographically progressed during or following one line of systemic treatment will be

enrolled in the study.

Inclusion Criteria:

Patients meeting all of the following criteria will be considered eligible for study entry:

1. Disease progression following first-line systemic therapy with any

fluoropyrimidine-based regimen for advanced disease (except FOLFOXIRI, see exclusion

criteria).

• Patients may have received prior neoadjuvant or adjuvant therapy which could have

included irinotecan or oxaliplatin. If progression has occurred within 12 months from

last dose of neoadjuvant or adjuvant treatment, this regimen will be considered as the

one line of systemic therapy for advanced disease.

- If assigned to receive FOLFIRI, patient may have received no prior irinotecan as

part of first-line systemic therapy.

- If assigned to receive FOLFOX, patient may have received no prior oxaliplatin as

part of first line systemic therapy.

- Prior treatment with an anti-VEGF or anti-EGFR therapy is allowed as first-line

and/or maintenance systemic therapy.

2. Able to provide written informed consent for any study specific procedures.

3. One or more tumors measurable on radiographic imaging as defined by RECIST 1.1

4. Sufficient tumor tissue for mandatory pre-treatment evaluation (fresh biopsy

[preferred], or archived tissue block specimen).

5. ECOG performance status ≤1 within 7 days of first dose of study drug. Acceptable

liver, renal, hematologic, and coagulation function

6. Females of childbearing potential and male partners of female patients must agree to

use adequate contraception during the study and for 6 months after their last dose of

study drug

Exclusion Criteria:

Patients meeting any of the following criteria are not eligible for study entry:

1. Diagnosis of Microsatellite instability-high (MSI-H)/mismatch repair-deficient (dMMR)

and/or BRAF V600E mutation positive colorectal cancer.

2. Prior therapy with an anti-DKK1, FOLFOXIRI, PD-1, anti-PD-L1, anti-PD-L-2 or any other

antibody or drug specifically targeting T-cell co-stimulation or coinhibitory

checkpoint.

3. Systemic anti-cancer therapy within 28 days prior to first dose of study drug.

4. Major surgery within 28 days prior to first dose of study drug.

5. Prior radiation therapy within 14 days prior to first dose of study drug.

6. Active leptomeningeal disease or uncontrolled brain metastases.

7. Any active cancer ≤ 2 years before first dose of study drug with the exception of

cancer for this study.

8. New York Heart Association Class III or IV cardiac disease, myocardial infarction

within the past 6 months, or unstable arrhythmia.

9. Fridericia-corrected QT interval (QTcF) > 470 msec (female) or history of congenital

long QT syndrome.

10. Active, uncontrolled bacterial, viral, or fungal infections, within 14 days of study

entry requiring systemic therapy.

11. Serious nonmalignant disease

12. Pregnant or nursing.

13. History of osteonecrosis of the hip or have evidence of structural bone abnormalities

in the proximal femur on MRI scan that are symptomatic and clinically significant.

14. Known osteoblastic bony metastasis.

15. Major surgery 28 days prior to study entry.

16. Prior radiation therapy within 14 days prior to study entry.

17. Significant allergy to a pharmaceutical therapy that, in the opinion of the

Investigator, poses an increased risk to the patient.

18. Active substance abuse.

19. Known dihydropyrimidine dehydrogenase deficiency.

20. Administration of a live vaccine within 28 days before first dose of study drug

Studien-Rationale

Primary outcome:

1. Progression Free Survival (PFS) (Time Frame - approximately 6 months):
PFS, as determined by the Investigator per RECIST v1.1 of DKN-01 plus SOC versus SOC.



Secondary outcome:

1. Objective Response Rate (ORR) (Time Frame - approximately 6 months):
ORR, as determined by the Investigator per RECIST v1.1 of DKN-01 plus SOC versus SOC

2. Duration of Response (DoR) (Time Frame - approximately 6 months):
DoR, as determined by the Investigator per RECIST v1.1 of DKN-01 plus SOC versus SOC

3. Overall Survival (OS) (Time Frame - approximately 6 months):
OS with DKN-01 plus SOC versus SOC

4. Incidence of ≥Grade 3 related treatment-related adverse events (TRAEs). (Time Frame - approximately 6 months)

Studien-Arme

  • Experimental: Treatment
    DKN-01 + FOLFIRI or FOLFOX + bevacizumab
  • Active Comparator: Control
    FOLFIRI or FOLFOX + bevacizumab

Geprüfte Regime

  • DKN-01 (LY2812176):
    30 minute IV infusion (400mg) every two weeks with an additional loading dose in the first cycle of treatment
  • FOLFIRI:
    90-min IV infusion of irinotecan, leucovorin, and fluorouracil followed by a continuous 46-hour infusion of fluorouracil every two weeks
  • Bevacizumab:
    90-min IV infusion (5mg)
  • FOLFOX:
    2 hour IV infusion of oxaliplatin, folinic acid, and fluorouracil followed by a continuous 46-hour infusion of fluorouracil every two weeks

Quelle: ClinicalTrials.gov


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