What's the purpose of this trial?
This is a Phase I/II, Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of AZD0305 in Patients with Relapsed or Refractory Multiple Myeloma.
This is an upcoming trial that has not yet started accepting patients.
What will happen during the trial?
You may be able to join this trial if you:
The following criteria is a partial list of reasons why patients may be
eligible to participate in this clinical trial. Further evaluation with a medical professional is
Key Inclusion Criteria:
1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
2. Life expectancy ≥ 6 months.
3. Subject must have receive 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).
4. Subject must have one or more measurable disease as the following measurements:
1) Serum M protein level ≥0.5g/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.
5. Subjects must show appropriate organ and marrow function.
Key Exclusion Criteria:
1. Subject has received anti-GPRC5D treatment previously.
2. Subject has previously received allogenic stem cell transplant, or subject has received autologous stem cell transplant within 3 months before administration of the IMP.
3. Primary refractory multiple myeloma (subject failed to generate any minimal response or any degree of response to any therapy).
4. Subject has received anti myeloma treatment (radiotherapy is excluded) within 2 weeks or 5 PK half-lives of the treatment, whichever longer, before the first study agent administration.
5. Subject is exhibiting clinical signs of central nervous system (CNS) involvement of MM.
6. Subject with known chronic obstructive pulmonary disease (COPD). 7. Subjects who have severe cardiovascular disease,
Additional Trial Information
Enrollment: 64 patients (estimated)