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

JRCT ID: jRCT2041240003

Registered date:03/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Relapsed or Refractory Multiple Myeloma
• Date of first enrollment: 30/07/2024
• Target sample size: 6
• Countries of recruitment: Australia,Japan,United States,Japan,Canada,Japan,China,Japan,Germany,Japan,Italy,Japan,Spain,Japan
• Study type: Interventional
• Intervention(s): AZD0305 IV every 3 weeks

Outcome(s)

Primary Outcome

Occurrence of dose-limiting toxicity (DLT), as defined in the protocol (Phase Ia dose escalation only)
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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 or less.

- 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 or more.
2. Urine M-protein level 200 mg/24h or more.
3. Serum immunoglobulin free light chain 10 mg/dL or more and abnormal serum immunoglobulin kappa lambda free l
ight 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).

Exclude 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 or more.

- 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.

Related Information

• Primary Sponsor: Hibi Kazushige
• Secondary ID(s): NCT06106945