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JOURNAL ONKOLOGIE – STUDIE

AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory Multiple Myeloma

Rekrutierend

NCT-Nummer:
NCT06106945

Studienbeginn:
Dezember 2023

Letztes Update:
30.04.2024

Wirkstoff:
AZD0305

Indikation (Clinical Trials):
Multiple Myeloma, Neoplasms, Plasma Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
AstraZeneca

Collaborator:
-

Kontakt

AstraZeneca Clinical Study Information Center
Kontakt:
Phone: 1-877-240-9479
E-Mail: information.center@astrazeneca.com» Kontaktdaten anzeigen

Studienlocations
(3 von 22)

Research Site
79106 Freiburg
(Baden-Württemberg)
GermanyZurückgezogen» Google-Maps
Research Site
20246 Hamburg
(Hamburg)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
23538 Lübeck
(Schleswig-Holstein)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
90419 Nürnberg
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
97080 Würzburg
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
48109 Ann Arbor
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
10065 New York
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
19104 Philadelphia
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
22031 Fairfax
United StatesNoch nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

This is a Phase I/II, modular, open-label, multicenter, dose escalation, and dose

expansion/optimization study to evaluate the safety, tolerability, PK, immunogenicity,

pharmacodynamics, and preliminary efficacy of AZD0305 in participants with RRMM. This study

will follow a modular protocol design evaluating AZD0305 as monotherapy and in combination

with other anticancer agents.

The study includes dose escalation and dose expansion phases. This study will enroll subjects

with RRMM who received at least 3 prior lines of treatment including at least one proteasome

inhibitor (PI), one immunomodulator (IMiD), and an anti-CD38 antibody. Subjects will be

administered AZD0305 intravenously.

Ein-/Ausschlusskriterien

Principal Inclusion Criteria:

- Participants must be at least 18 years of age or the legal age of consent in the

jurisdiction in which the study is taking place.

- Eastern Cooperative Oncology group (ECOG) performance status of ≤ 2.

- Documentation of Multiple Myeloma (MM) as defined by International Myeloma Working

Group (IMWG) Diagnostic Criteria for Multiple Myeloma. Site should ensure that

Multiple Myeloma diagnosis is confirmed in accordance with the IMWG Diagnostic

Criteria.

- Participants must have one or more of the following measurable disease criteria:

1. Serum M-protein level ≥ 0.5 g/dL.

2. Urine M-protein level ≥ 200 mg/24h.

3. Serum immunoglobulin free light chain ≥ 10 mg/dL and abnormal serum

immunoglobulin kappa lambda free light chain ratio.

- Adequate organ and bone marrow function assessment at screening according to the

hematological, hepatic, and renal parameters listed in the CSP.

- Participants must have received at least 3 prior lines of treatment which include a

proteasome inhibitor (e.g., bortezomib), an immunomodulator (e.g., lenalidomide), and

an anti-CD38 antibody (e.g., daratumumab).

Principal Exclusion Criteria:

- Participants exhibiting clinical signs of central nervous system involvement of MM.

- Participants with known COPD, or previous history of ILD.

- Participants with known moderate or severe persistent asthma within the past 5 years,

or uncontrolled asthma of any classification.

- Participants who have severe cardiovascular disease which is not adequately

controlled.

- Participants who have a history of immunodeficiency disease.

- Participants with peripheral neuropathy ≥ Grade 2.

- Primary refractory MM.

- Participants who have previously received anti-GPRC5D or MMAE-containing treatment.

- Participants who have previously received allogenic stem cell transplant, or

participant has received autologous stem cell transplant within 3 months before the

first dose of study intervention.

Studien-Rationale

Primary outcome:

1. Occurrence of dose-limiting toxicity (DLT), as defined in the protocol (Phase Ia dose escalation only) (Time Frame - From first dose of study treatment until the end of Cycle 1):
A DLT is defined as any toxicity that occurs from the first dose of study treatment up to and including the planned end of Cycle 1 (the DLT assessment period) that is assessed as unrelated to the disease or disease-related processes under investigation and which includes, any death not clearly due to the underlying disease or extraneous causes, pre-defined haematological and non-haematological toxicities

2. Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) (Time Frame - From time of Informed consent to 30 days post end of treatment):
Number of patients with adverse events and serious adverse events by system organ class and preferred term

Secondary outcome:

1. Phase Ia: Objective Response Rate (ORR) (Time Frame - From first dose of AZD0305 to progressive disease or Initiation of subsequent MM therapy (approximately 2 years)):
The percentage of patients with a confirmed investigator assessed sCR, CR, VGPR or PR according to IMWG criteria

2. Phase Ia: Duration of response (DoR) (Time Frame - From the first documented response to confirmed progressive disease or death (approximately 2 years)):
The time from the date of first response until date of disease progression or death in the absence of disease progression

3. Phase Ia: Progression free Survival (PFS) (Time Frame - From first dose of AZD0305 to progressive disease or death in the absence of disease progression (approximately 2 years)):
The time from first dose until IMWG defined disease progression or death

4. Phase Ia: Overall Survival (OS) (Time Frame - From first dose of AZD0305 to death (approximately 2 years)):
The time from the date of the first dose of study treatment until death due to any cause

5. Phase Ia: Pharmacokinetics of AZD0305: Area Under the concentration-time curve (AUC) (Time Frame - From the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)):
Area under the plasma concentration-time curve

6. Phase Ia: Pharmacokinetics of AZD0305: Maximum plasma concentration of the study drug (Cmax) (Time Frame - From the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)):
Maximum observed plasma concentration of the study drug

7. Phase Ia: Pharmacokinetics of AZD0305: Time to maximum plasma concentration of the study drug (tmax) (Time Frame - From the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)):
Time to maximum observed plasma concentration of the study drug

8. Phase Ia: Pharmacokinetics of AZD0305: Clearance (Time Frame - From the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)):
A pharmacokinetic measurement of the volume of plasma from which the study drug is completely removed per unit time

9. Phase Ia: Pharmacokinetics of AZD0305: Terminal elimination half-life (t 1/2) (Time Frame - From the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)):
Terminal elimination half-life

10. Phase Ia: Immunogenicity of AZD0305 (Time Frame - From the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)):
The number and percentage of participants who develop ADAs

11. Phase Ib: Objective Response Rate (ORR) (Time Frame - From randomization to progressive disease or Initiation of subsequent MM therapy (approximately 2 years)):
The percentage of patients with a confirmed investigator assessed sCR, CR, VGPR or PR according to IMWG criteria

12. Phase Ib: Duration of response (DoR) (Time Frame - From randomization to confirmed progressive disease or death (approximately 2 years)):
The time from date of first response until date of disease progression or death in the absence of disease progression

13. Phase Ib: Progression free Survival (PFS) (Time Frame - From randomization to progressive disease or death in the absence of disease progression (approximately 2 years)):
The time from randomization until IMWG defined disease progression or death

14. Phase Ib: Overall Survival (OS) (Time Frame - From randomization to death (approximately 2 years)):
The time from randomization until death due to any cause

15. Phase Ib: Pharmacokinetics of AZD0305: Area Under the concentration-time curve (AUC) (Time Frame - From randomization, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)):
Area under the plasma concentration-time curve

16. Phase Ib: Pharmacokinetics of AZD0305: Maximum plasma concentration of the study drug (Cmax) (Time Frame - From randomization, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)):
Maximum observed plasma concentration of the study drug

17. Phase Ib: Pharmacokinetics of AZD0305: Time to maximum plasma concentration of the study drug (tmax) (Time Frame - From randomization, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)):
Time to maximum observed plasma concentration of the study drug

18. Phase Ib: Pharmacokinetics of AZD0305: Clearance (Time Frame - From randomization, at predefined intervals throughout the administration of AZD0305 (approximately 2 years):
A pharmacokinetic measurement of the volume of plasma from which the study drug is completely removed per unit time

19. Phase Ib: Pharmacokinetics of AZD0305: Terminal elimination half-life (t 1/2) (Time Frame - From randomization, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)):
Terminal elimination half-life

20. Phase Ib: Immunogenicity of AZD0305 (Time Frame - From randomization, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)):
The number and percentage of participants who develop ADAs

Geprüfte Regime

  • AZD0305:
    AZD0305

Quelle: ClinicalTrials.gov


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