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JOURNAL ONKOLOGIE – STUDIE

Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia

Rekrutierend

NCT-Nummer:
NCT04623541

Studienbeginn:
November 2020

Letztes Update:
06.01.2021

Wirkstoff:
Epcoritamab

Indikation (Clinical Trials):
Leukemia, Leukemia, Lymphoid, Leukemia, Lymphocytic, Chronic, B-Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Genmab

Collaborator:
AbbVie

Kontakt

Studienlocations (3 von 10)

University of Cologne
Köln
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Hackensack Meridian Hospital
07601 Hackensack
United StatesNoch nicht rekrutierend» Google-Maps
Fred Hutchinson Cancer Research Center
98109 Seattle
United StatesNoch nicht rekrutierend» Google-Maps
Universitair Medisch Centrum Groningen
9713 Groningen
NetherlandsNoch nicht rekrutierend» Google-Maps
Maastricht University Medical Center
6229 Maastricht
NetherlandsNoch nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

The purpose of the escalation part of the trial is to determine the recommended phase 2 dose

(RP2D) and the maximum tolerated dose (if reached) as well as establish the safety profile of

epcoritamab in patients with R/R CLL.

In the expansion part additional patients will be treated with epcoritamab at the RP2D and

the the purpose is to assess and evaluate the preliminary efficacy, safety and tolerability

profiles of epcoritamab at the RP2D.

Ein-/Ausschlusskriterien

Inclusion Criteria

1. Subject must sign an ICF, prior to any screening procedures.

2. Must have active CLL disease that needs treatment per iwCLL2018

3. R/R CLL after receiving at least 2 prior lines of systemic antineoplastic therapy,

including treatment with (or intolerance of) a BTK inhibitor

4. Has Measurable Disease with ≥5 × 109/L (5,000/μL) B lymphocytes in peripheral blood or

Presence of measurable lymphadenopathy and/or organomegaly

5. ECOG performance status score of 0 or 1

6. Screening flow cytometry evidence of CD20 positivity

7. Has laboratory parameters as follows:

a. HBG-≥9.0 g/dL; ANC-≥1.0 x 109/L; Platelets-≥30 x 109/L

8. Received a cumulative dose of corticosteroids less than the equivalent of 250 mg of

prednisone within the 2-week period before the first dose

9. Availability of fresh bone marrow material

10. Must take prophylaxis for TLS

11. A woman must be either not of childbearing potential or of childbearing potential and

practicing a highly effective method of birth control, and must have a negative serum

beta-human chorionic gonadotropin (beta-hCG) and urine pregnancy test at screening.

12. A man who is sexually active with a woman of childbearing potential and has not had a

vasectomy must agree to use a barrier method of birth control.

Exclusion Criteria

1. Transformation of CLL to aggressive non-Hodgkin lymphoma

2. Received prior treatment with a CD3 × CD20 bispecific antibody.

3. Received any prior allogeneic HSCT or solid organ transplantation.

4. Received treatment with an anti-cancer biologic including anti-CD20 therapy,

radio-conjugated or toxin-conjugated antibody or CAR T-cell therapy or investigational

drug or medical device within 4 weeks, before the first dose.

5. Received chemotherapy or radiation therapy within 2 weeks of the first dose of

epcoritamab.

6. Has autoimmune disease or other diseases that require permanent or high-dose

immunosuppressive therapy.

7. Has uncontrolled intercurrent illness.

8. Toxicities from previous anti-cancer therapies have not resolved to baseline levels or

to Grade 1 or less except for alopecia and peripheral neuropathy.

9. Primary central nervous system (CNS) lymphoma or known CNS involvement at screening.

10. Known past or current malignancy other than inclusion diagnosis

11. Subject has suspected allergies, hypersensitivity, or intolerance to epcoritamab or

its excipients.

12. Subject is unable to tolerate uric acid reducing medications

13. Has had major surgery within 3 weeks before screening or will not have fully recovered

from surgery, or has major surgery planned during the time the subject is expected to

participate in the trial (or within 4 weeks after the last dose of epcoritamab).Known

history/positive serology for hepatitis B.

14. Known medical history or ongoing hepatitis C infection that has not been cured.

15. HIV tested positive at screening.

16. Is a woman who is pregnant or breast-feeding, or who is planning to become pregnant

while enrolled in this trial or within 12 months after the last dose of epicoritamab.

17. Is a man who plans to father a child while enrolled in this trial or within 12 months

after the last dose of epicoritamab.

Studien-Rationale

Primary outcome:

1. Dose escalation part: Incidence of dose limiting toxicities (DLTs) (Time Frame - For each subject in a given dose escalation cohort, DLTs are assessed during the first cycle (28 days).):
To identify the recommended phase II dose (RP2D)

2. Dose escalation part: Incidence of dose limiting toxicities (DLTs) (Time Frame - For each subject in a given dose escalation cohort, DLTs are assessed during the first cycle (28 days).):
To identify maximum tolerated dose (MTD) if reached

3. Dose expansion part: assess preliminary efficacy of epcoritamab (Time Frame - response assessments will be evaluated evaluated on an ongoing basis during the conduct of the trial (up to 3 years after the last subject first dose)):
overall response rate

4. Dose escalation and expansion part: Adverse events (AEs) (Time Frame - AEs are collected throughout trial until the end of the safety follow-up period (60 days after last dose)):
To assess the safety and tolerability of epcoritamab throughout the treatment period of patients participating in the trial)

Secondary outcome:

1. Dose escalation and expansion part: To characterize the pharmacokinetic properties of epcoritamab (Time Frame - assessed through trial until the end of the treatment period, expected average of 1 year):
Pharmacokinetic (PK) parameters Clearance (Cl)

2. Dose escalation and expansion part: To characterize the pharmacokinetic properties of epcoritamab (Time Frame - assessed through trial until the end of the treatment period, expected average of 1 year):
PK parameters Volume of Distrubution (Vd)

3. Dose escalation and expansion part: To characterize the pharmacokinetic properties of epcoritamab (Time Frame - assessed through trial until the end of the treatment period, expected average of 1 year):
PK parameters maximum (peak) plasma drug concentration (Cmax)

4. Dose escalation and expansion part: To characterize the pharmacokinetic properties of epcoritamab (Time Frame - assessed through trial until the end of the treatment period, expected average of 1 year):
PK parameters time to reach maximum (peak) plasma concentration (Tmax)

5. Dose escalation and expansion part: To characterize the pharmacokinetic properties of epcoritamab (Time Frame - assessed through trial until the end of the treatment period, expected average of 1 year):
PK parameters Area under the concentration-time curve (AUC) from time zero to last quantifiable sample

6. Dose escalation and expansion part: To characterize the pharmacokinetic properties of epcoritamab (Time Frame - assessed through trial until the end of the treatment period, expected average of 1 year):
PK parameters Area under the concentration-time curve (AUC) from time zero to infinity

7. Dose escalation and expansion part: To characterize the pharmacokinetic properties of epcoritamab (Time Frame - assessed through trial until the end of the treatment period, expected average of 1 year):
PK parameters pre-dose (trough) concentrations

8. Dose escalation and expansion part: To characterize the pharmacokinetic properties of epcoritamab (Time Frame - assessed through trial until the end of the treatment period, expected average of 1 year):
PK parameters elimination half-life (T1/2)

9. Dose escalation and expansion part: To evaluate pharmacodynamic markers of epcoritamab (Time Frame - assessed through trial until the end of the treatment period, expected average of 1 year):
pharmacodynamic (PD) marker cytokines

10. Dose escalation and expansion part: To evaluate pharmacodynamic markers of epcoritamab (Time Frame - assessed through trial until the end of the treatment period, expected average of 1 year):
pharmacodynamic (PD) marker immune subset CD4

11. Dose escalation and expansion part: To evaluate pharmacodynamic markers of epcoritamab (Time Frame - assessed through trial until the end of the treatment period, expected average of 1 year):
pharmacodynamic (PD) marker immune subset CD8

12. Dose escalation and expansion part: To evaluate pharmacodynamic markers of epcoritamab (Time Frame - assessed through trial until the end of the treatment period, expected average of 1 year):
pharmacodynamic (PD) marker immune subset B cells

13. Dose escalation and expansion part: To evaluate pharmacodynamic markers of epcoritamab (Time Frame - assessed through trial until the end of the treatment period, expected average of 1 year):
pharmacodynamic (PD) marker immune subset activation marker positive/expression level

14. Dose escalation and expansion part: Evaluate the immunogenicity of epcoritamab (Time Frame - assessed through trial until the end of the treatment period, expected average of 1 year):
incidence of antidrug-antibodies to epcoritamab

15. Dose escalation part: Assess the preliminary anti-tumor activity of epcoritamab (Time Frame - response assessments will be evaluated evaluated on an ongoing basis during the conduct of the trial (up to 3 years after the last subject first dose)):
overall response rate

16. Dose escalation and expansion part: Assess the preliminary anti-tumor activity of epcoritamab (Time Frame - response assessments will be evaluated evaluated on an ongoing basis during the conduct of the trial (up to 3 years after the last subject first dose)):
duration of response

17. Dose escalation and expansion part: Assess the preliminary anti-tumor activity of epcoritamab (Time Frame - response assessments will be evaluated evaluated on an ongoing basis during the conduct of the trial (up to 3 years after the last subject first dose)):
time to response

18. Dose escalation and expansion part: Assess the preliminary anti-tumor activity of epcoritamab (Time Frame - response assessments will be evaluated evaluated on an ongoing basis during the conduct of the trial (up to 3 years after the last subject first dose)):
progression free survival

19. Dose escalation and expansion part: Assess the preliminary anti-tumor activity of epcoritamab (Time Frame - response assessments will be evaluated evaluated on an ongoing basis during the conduct of the trial (up to 3 years after the last subject first dose)):
overall survival

Geprüfte Regime

  • Epcoritamab (GEN3013; DuoBody®-CD3xCD20):
    Epcoritamab will be administered in cycles of 28 days.

Quelle: ClinicalTrials.gov


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