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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06106945




Registration number
NCT06106945
Ethics application status
Date submitted
11/10/2023
Date registered
30/10/2023

Titles & IDs
Public title
AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed/Refractory Multiple Myeloma
Scientific title
A Modular Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Lmmunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0305 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Relapsed or Refractory Multiple Myeloma
Secondary ID [1] 0 0
2023-508590-89-00
Secondary ID [2] 0 0
D7230C00001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AZD0305

Experimental: AZD0305 monotherapy - Module 1:

Phase Ia: Dose Escalation Phase Ib: Dose Expansion/Optimization AZD0305 will be prescribed at specified dose levels.


Treatment: Drugs: AZD0305
AZD0305
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Occurrence of dose-limiting toxicity (DLT), as defined in the protocol (Phase Ia dose escalation only)
Timepoint [1] 0 0
From first dose of study treatment until the end of Cycle 1
Primary outcome [2] 0 0
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [2] 0 0
From time of Informed consent to 30 days post end of treatment
Secondary outcome [1] 0 0
Phase Ia: Objective Response Rate (ORR)
Timepoint [1] 0 0
From first dose of AZD0305 to progressive disease or Initiation of subsequent MM therapy (approximately 2 years)
Secondary outcome [2] 0 0
Phase Ia: Duration of response (DoR)
Timepoint [2] 0 0
From the first documented response to confirmed progressive disease or death (approximately 2 years)
Secondary outcome [3] 0 0
Phase Ia: Progression free Survival (PFS)
Timepoint [3] 0 0
From first dose of AZD0305 to progressive disease or death in the absence of disease progression (approximately 2 years)
Secondary outcome [4] 0 0
Phase Ia: Overall Survival (OS)
Timepoint [4] 0 0
From first dose of AZD0305 to death (approximately 2 years)
Secondary outcome [5] 0 0
Phase Ia: Pharmacokinetics of AZD0305: Area Under the concentration-time curve (AUC)
Timepoint [5] 0 0
From the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Secondary outcome [6] 0 0
Phase Ia: Pharmacokinetics of AZD0305: Maximum plasma concentration of the study drug (Cmax)
Timepoint [6] 0 0
From the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Secondary outcome [7] 0 0
Phase Ia: Pharmacokinetics of AZD0305: Time to maximum plasma concentration of the study drug (tmax)
Timepoint [7] 0 0
From the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Secondary outcome [8] 0 0
Phase Ia: Pharmacokinetics of AZD0305: Clearance
Timepoint [8] 0 0
From the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Secondary outcome [9] 0 0
Phase Ia: Pharmacokinetics of AZD0305: Terminal elimination half-life (t 1/2)
Timepoint [9] 0 0
From the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Secondary outcome [10] 0 0
Phase Ia: Immunogenicity of AZD0305
Timepoint [10] 0 0
From the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Secondary outcome [11] 0 0
Phase Ib: Objective Response Rate (ORR)
Timepoint [11] 0 0
From randomization to progressive disease or Initiation of subsequent MM therapy (approximately 2 years)
Secondary outcome [12] 0 0
Phase Ib: Duration of response (DoR)
Timepoint [12] 0 0
From randomization to confirmed progressive disease or death (approximately 2 years)
Secondary outcome [13] 0 0
Phase Ib: Progression free Survival (PFS)
Timepoint [13] 0 0
From randomization to progressive disease or death in the absence of disease progression (approximately 2 years)
Secondary outcome [14] 0 0
Phase Ib: Overall Survival (OS)
Timepoint [14] 0 0
From randomization to death (approximately 2 years)
Secondary outcome [15] 0 0
Phase Ib: Pharmacokinetics of AZD0305: Area Under the concentration-time curve (AUC)
Timepoint [15] 0 0
From randomization, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Secondary outcome [16] 0 0
Phase Ib: Pharmacokinetics of AZD0305: Maximum plasma concentration of the study drug (Cmax)
Timepoint [16] 0 0
From randomization, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Secondary outcome [17] 0 0
Phase Ib: Pharmacokinetics of AZD0305: Time to maximum plasma concentration of the study drug (tmax)
Timepoint [17] 0 0
From randomization, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Secondary outcome [18] 0 0
Phase Ib: Pharmacokinetics of AZD0305: Clearance
Timepoint [18] 0 0
From randomization, at predefined intervals throughout the administration of AZD0305 (approximately 2 years
Secondary outcome [19] 0 0
Phase Ib: Pharmacokinetics of AZD0305: Terminal elimination half-life (t 1/2)
Timepoint [19] 0 0
From randomization, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Secondary outcome [20] 0 0
Phase Ib: Immunogenicity of AZD0305
Timepoint [20] 0 0
From randomization, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)

Eligibility
Key inclusion criteria
Principal

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
11/11/2025
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Melbourne
Recruitment hospital [2] 0 0
Research Site - Perth
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment postcode(s) [2] 0 0
WA 6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
Canada
State/province [10] 0 0
Quebec
Country [11] 0 0
China
State/province [11] 0 0
Beijing
Country [12] 0 0
China
State/province [12] 0 0
Changsha
Country [13] 0 0
China
State/province [13] 0 0
Guangzhou
Country [14] 0 0
China
State/province [14] 0 0
Shenyang
Country [15] 0 0
France
State/province [15] 0 0
Lille
Country [16] 0 0
France
State/province [16] 0 0
Nantes
Country [17] 0 0
Germany
State/province [17] 0 0
Essen
Country [18] 0 0
Germany
State/province [18] 0 0
Freiburg
Country [19] 0 0
Germany
State/province [19] 0 0
Hamburg
Country [20] 0 0
Germany
State/province [20] 0 0
Lübeck
Country [21] 0 0
Germany
State/province [21] 0 0
Nürnberg
Country [22] 0 0
Germany
State/province [22] 0 0
Wuerzburg
Country [23] 0 0
Japan
State/province [23] 0 0
Kashiwa
Country [24] 0 0
Japan
State/province [24] 0 0
Nagoya-shi
Country [25] 0 0
Japan
State/province [25] 0 0
Yamagata-shi
Country [26] 0 0
Spain
State/province [26] 0 0
Madrid
Country [27] 0 0
Spain
State/province [27] 0 0
Pamplona
Country [28] 0 0
Spain
State/province [28] 0 0
Salamanca

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06106945