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JOURNAL ONKOLOGIE – STUDIE

A Study of BLZ945 Single Agent or BLZ945 in Combination With PDR001 in Advanced Solid Tumors

Rekrutierend

NCT-Nummer:
NCT02829723

Studienbeginn:
Oktober 2016

Letztes Update:
02.06.2021

Wirkstoff:
BLZ945, PDR001

Indikation (Clinical Trials):
Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Novartis Pharmaceuticals

Collaborator:
-

Studienleiter

Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals

Kontakt

Studienlocations
(3 von 15)

Sarah Cannon Research Institute Sarah Cannon Research
37203 Nashville
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Erica Mills
Phone: 615-289-9227
E-Mail: erica.mills@sarahcannon.com
» Ansprechpartner anzeigen
Cancer Therapy and Research Center UT Health Science Center
78229 San Antonio
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Maghan Rios
Phone: 210-450-3838
E-Mail: riosm7@uthscsa.eud
» Ansprechpartner anzeigen
Novartis Investigative Site
6423906 Tel Aviv
IsraelRekrutierend» Google-Maps
Novartis Investigative Site
135 8550 Koto ku
JapanRekrutierend» Google-Maps
Novartis Investigative Site
169610 Singapore
SingaporeRekrutierend» Google-Maps
Novartis Investigative Site
08907 Hospitalet de LLobregat
SpainRekrutierend» Google-Maps
Novartis Investigative Site
8091 Zurich
SwitzerlandRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of this first-in-human (FIH) study of BLZ945 given as a single agent or in

combination with PDR001 is to characterize the safety, tolerability, pharmacokinetics (PK),

pharmacodynamics, and anti-tumor activity of BLZ945, administered orally, as a single agent

or in combination with PDR001, administered intravenously (i.v.) in adult patients with

advanced solid tumors.

Dose escalation will be guided by a Bayesian logistic regression model with overdose control.

Once MTD/ RP2D is declared, glioblastoma patients will be enrolled in the phase II part to

further assess the preliminary anti-tumor activity of BLZ945 as single agent and in

combination with PDR001.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Phase I: Patients with advanced/metastatic solid tumors, with measurable or

unmeasurable disease as determined by Response Evaluation Criteria in Solid Tumors

(RECIST) version 1.1

2. Phase I: Patients with a site of disease amenable to biopsy, and willing to undergo a

new tumor biopsy at screening, and during treatment.

3. Phase II: Patients with advanced/metastatic/recurrent isocitrate dehydrogenase (IDH)

wild-type glioblastoma, with at least one measurable lesion as determined by RANO

Other protocol defined inclusion criteria may apply

Exclusion Criteria:

1. History of severe hypersensitivity reactions to monoclonal antibodies.

2. Impaired cardiac function or clinically significant cardiac disease.

3. Active autoimmune disease or a documented history of autoimmune disease.

4. Systemic steroid therapy or any immunosuppressive therapy

5. Use of any vaccines against infectious diseases within 4 weeks of initiation of study

treatment.

6. Patient receiving treatment with medications that either strong inducers or inhibitors

of CYP2C8 or CYP3A4/5, or patients receiving medication that prohibits proton pump

inhibitors and that cannot be discontinued at least 1 week prior to start of treatment

and for the duration of the study.

Other protocol defined exclusion criteria may apply.

Studien-Rationale

Primary outcome:

1. Incidence of Dose limiting toxicities (Phase I) (Time Frame - 5 years):
To identify the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D)

2. Incidence of Adverse Events (Phase I) (Time Frame - 5 years):
To identify the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D)

3. Incidence of Serious Adverse Events (Phase I) (Time Frame - 5 years):
To identify the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D)

4. Dose interruptions (Phase I) (Time Frame - 5 years):
To identify the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D)

5. Dose reductions (Phase I) (Time Frame - 5 years):
To identify the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D)

6. Dose intensity (Phase I) (Time Frame - 5 years):
To identify the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D)

7. Progression-free survival probability (PFSP) at 6 months (Phase II) (Time Frame - 6 months):
Percentage of participants with Progression Free Survival (PFS) at 6 months per RANO criteria

Secondary outcome:

1. CD163 (Phase I) (Time Frame - 5 years):
On treatment versus baseline comparison of pharmacodynamics markers expressions by immunohistochemistry

2. CD8 (Phase I) (Time Frame - 5 years):
On treatment versus baseline comparison of pharmacodynamics markers expressions by immunohistochemistry

3. Progression Free Survival (PFS) (Phase I) (Time Frame - 5 years):
Evaluation is based on RECISTv1.1 or irRC or RANO or iRANO

4. Best Overall Response (BOR) (Phase I) (Time Frame - 5 years):
Evaluation is based on RECISTv1.1 or irRC or RANO or iRANO

5. Disease Control Rate (DCR) (Phase I) (Time Frame - 5 years):
Evaluation is based on RECISTv1.1 or RANO

6. PFS (Phase II) (Time Frame - 5 years):
Evaluation is based on iRANO

7. BOR (Phase II) (Time Frame - 5 years):
Evaluation is based on RANO or iRANO

8. Duration Of Response (DOR) (Phase II) (Time Frame - 5 years):
Evaluation is based on RANO or iRANO

9. DCR (Phase II) (Time Frame - 5 years):
Evaluation is based on RANO or iRANO

10. Overall Survival (OS) (Phase II) (Time Frame - 6 years):
every 12 weeks until end of study

11. Incidence of AEs (Phase II) (Time Frame - 5 years)

12. Incidence of SAEs (Phase II) (Time Frame - 5 years):
Assessment to be completed at least every 28 days

13. Pharmacokinetics (PK) Area Under the Curve (AUC) (BLZ945 single agent) (Time Frame - 5 years)

14. PK AUC (BLZ945 + PDR001) (Time Frame - 5 years)

15. PK Time of maximum concentration observed (Tmax) (BLZ945 single agent) (Time Frame - 5 years)

16. PK Tmax (BLZ945 + PDR001) (Time Frame - 5 years)

17. PK peak serum concentration (Cmax) (BLZ945 + PDR001) (Time Frame - 5 years)

18. PK Cmax (BLZ945 single agent) (Time Frame - 5 years)

19. Concentration of anti-PDR001 antibodies (BLZ945 + PDR001) (Time Frame - 5 years)

Studien-Arme

  • Experimental: BLZ945 single agent
  • Experimental: BLZ945 + PDR001

Geprüfte Regime

  • BLZ945
  • PDR001

Quelle: ClinicalTrials.gov


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