Multiple MyelomaPhase 1/2NCT06106945
AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple Myeloma
A Phase 1/2 study testing AZD0305, Elranatamab and Pomalidomide in people with Multiple Myeloma, run by AstraZeneca at 43 sites in 9 countries.
Trial summary
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 efficacy of AZD0305 as monotherapy and in combination with other anticancer agents in participants with MM. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- AZD0305, Elranatamab and Pomalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 43 sitesin 9 countries
- Study dates
- 5 Dec 2023to 16 Aug 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 performance status of ≤ 2 in module 1, or 0 or 1 in modules 2 and 3;
- 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 measurable disease criteria for Serum M-Protein, Urine M-protein, and Serum immunoglobulin free light chains as specified in the relevant module of the CSP;
- Adequate organ and bone marrow function assessment at screening according to the hematological, hepatic, and renal parameters listed in the CSP as relevant to each module;
- Participants must have received at least 3 prior lines of treatment in module 1, or 1-3 prior lines in modules 2 and 3, with additional module-specific requirements related to prior lines of therapy
- The above is a summary of key criteria, other inclusion criteria details may apply
Who cannot join
- Amyloidosis, plasma cell leukemia, Waldenstrom Macroglobulinemia, Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin Syndrome, or Smoldering Multiple Myeloma (compliant with WHO criteria);
- Participants exhibiting clinical signs of central nervous system involvement of MM;
- Participants with known COPD, or previous history of ILD/pneumonitis;
- 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;
Show all 15Show fewer
- 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;
- Participants with a history of prior malignancy other than MM within 3 years prior to first dose of study intervention. some exceptions apply;
- Participants with previous history of active JC virus infection resulting in PML;
- Participants with a known hypersensitivity to AZD0305 or any of the excipients of the product or to any of the drugs included in the respective modules or who experienced Grade 3 or higher hypersensitivity to prior monoclonal antibody therapy;
- Participants who have uncontrolled severe illness including but not limited to ongoing active infection requiring therapeutic antibiotics and/or other administration
- The above is a summary of key criteria, other exclusion criteria details may apply
Trial locations and contacts
43 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
43 sites in 9 countries
United States9 sites, 8 recruiting
- Recruiting
Research Site
Ann Arbor, Michigan, 48109
- Recruiting
Research Site
Atlanta, Georgia, 30322
- Recruiting
Research Site
Boston, Massachusetts, 02215
- Recruiting
Research Site
Duarte, California, 91010
- Recruiting
Research Site
Fairfax, Virginia, 22031
- Recruiting
Research Site
Irvine, California, 92618
- Recruiting
Research Site
New York, New York, 10065
- Recruiting
Research Site
Philadelphia, Pennsylvania, 19104
- Withdrawn
Research Site
St Louis, Missouri, 63110
Germany8 sites, 7 recruiting
- Recruiting
Research Site
Essen, 45147
- Withdrawn
Research Site
Freiburg im Breisgau, 79106
- Recruiting
Research Site
Hamburg, 20246
- Not yet recruiting
Research Site
Heidelberg, 69120
- Recruiting
Research Site
Lübeck, 23538
- Recruiting
Research Site
Nuremberg, 90419
- Not yet recruiting
Research Site
Tübingen, 72076
- Recruiting
Research Site
Würzburg, 97080
Canada5 sites, 5 recruiting
- Recruiting
Research Site
Hamilton, Ontario, L8V 5C2
- Recruiting
Research Site
Montreal, Quebec, H4A 3J1
- Not yet recruiting
Research Site
Nova Scotia, B3H 1V7
- Recruiting
Research Site
Ottawa, Ontario, K1H 8L6
- Not yet recruiting
Research Site
Toronto, Ontario, M5G 2M9
Spain5 sites, 5 recruiting
- Not yet recruiting
Research Site
Badalona, 8916
- Recruiting
Research Site
Madrid, 28027
- Recruiting
Research Site
Madrid, 28041
- Recruiting
Research Site
Pamplona, 31005
- Recruiting
Research Site
Salamanca, 37007
Australia4 sites, 4 recruiting
- Recruiting
Research Site
Fitzroy, VIC3065
- Recruiting
Research Site
Melbourne, 3000
- Recruiting
Research Site
Nedlands, 6009
- Not yet recruiting
Research Site
Wollongong, 2500
China4 sites, 4 recruiting
- Recruiting
Research Site
Beijing, 100044
- Recruiting
Research Site
Changsha, 410013
- Recruiting
Research Site
Guangzhou, 510060
- Recruiting
Research Site
Shenyang, 110134
Brazil3 sites, 3 recruiting
- Not yet recruiting
Research Site
Salvador, 41253-190
- Not yet recruiting
Research Site
São Paulo, 04537-080
- Not yet recruiting
Research Site
São Paulo, 05652000
Japan3 sites, 3 recruiting
- Recruiting
Research Site
Kashiwa, 277-8577
- Recruiting
Research Site
Nagoya, 467-8602
- Recruiting
Research Site
Yamagata, 990-9585
France2 sites, 2 recruiting
- Recruiting
Research Site
Lille, 59037
- Recruiting
Research Site
Nantes, 44000
About this study
Official title: A Modular Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0305 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Multiple Myeloma
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 efficacy of AZD0305 as monotherapy and in combination with other anticancer agents in participants with MM.
Read the detailed description
This study will follow a modular protocol design evaluating AZD0305 as monotherapy and in combination with other anticancer agents. The protocol may be amended in the future to incorporate further monotherapy expansion at the recommended Phase 2 dose (RP2D) in Phase II, and/or additional modules investigating AZD0305 in combination with other anticancer agents.
The study consists of 3 modules:
- Module 1 (AZD0305 monotherapy),
- Module 2 (AZD0305 in combination with elranatamab)
- Module 3 (AZD0305 in combination with pomalidomide and dexamethasone [Pd])
- Conditions
- Multiple Myeloma
- Being tested
- AZD0305, Elranatamab, Pomalidomide, Dexamethasone
- Keywords
- GPRC5D, ADC, AZD0305, Multiple Myeloma, MM, MMAE
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD0305Drug
AZD0305 Investigational product
ElranatamabDrug
Module 2 Investigational product
PomalidomideDrug
Module 3 Standard of Care (background treatment)
DexamethasoneDrug
Module 3 Standard of Care (background treatment)
| Study group | Role | What they receive |
|---|---|---|
| AZD0305 monotherapy | Experimental | Module 1:
Phase Ia: Dose Escalation Phase Ib: Dose Expansion/Optimization AZD0305 will be administered at specified dose levels. Receives: Drug: AZD0305 |
| AZD0305 + Elranatamab | Experimental | Module2:
Phase 1a: Dose escalation and Phase 1b: Backfills, AZD0305 will be administered in combination with elranatamab, following the module-specific dosing. Receives: Drug: AZD0305; Drug: Elranatamab |
| AZD0305 + Pomalidomide and Dexamethasone | Experimental | Module3:
Phase 1a: Dose escalation and Phase 1b: Backfills, AZD0305 will be administered in combination with pomalidomide and dexamethasone, following the module-specific dosing. Receives: Drug: AZD0305; Drug: Pomalidomide; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of dose-limiting toxicity (DLT), as defined in the protocol (Phase Ia dose escalation only)
A DLT is any toxicity occuring from the first dose of AZD0305 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
Measured: From first dose of AZD0305 until the end of Cycle 1. Cycle 1 (the DLT assessment period is 21 days for Module 1 Group A and 28 days for Module 1 Group B, Module 2, and Module 3)
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of patients with adverse events and serious adverse events by system organ class and preferred term
Measured: From time of Informed consent to 30 days post end of treatment
Frequency of dose modifications, dose delays, and treatment discontinuations due to AEs (Module 2 and Module 3)
Number and percentage of participants with dose modifications, dose delays, and permanent discontinuations due to adverse events (for AZD0305 and combination agent[s], as applicable), per protocol-defined dose modification rules.
Measured: From first dose of study treatment until End of treatment (EOT), assessed up to approximately 2 years (each cycle is 28 days)
Secondary outcomes (26)
Phase Ia: Objective Response Rate (ORR)
The percentage of patients with a confirmed investigator assessed sCR, CR, VGPR or PR according to IMWG criteria
Measured: From first dose of AZD0305 to progressive disease or Initiation of subsequent MM therapy (approximately 2 years)
Phase Ia: Duration of response (DoR)
The time from the date of first response until date of disease progression or death in the absence of disease progression
Measured: From the first documented response to confirmed progressive disease or death (approximately 2 years)
Phase Ia: Progression free Survival (PFS)
The time from first dose until IMWG defined disease progression or death
Measured: From first dose of AZD0305 to progressive disease or death in the absence of disease progression (approximately 2 years)
Phase Ia: Overall Survival (OS)
The time from the date of the first dose of study treatment until death due to any cause
Measured: From first dose of AZD0305 to death (approximately 2 years)
Phase Ia: Pharmacokinetics of AZD0305: Area Under the concentration-time curve (AUC)
Area under the plasma concentration-time curve
Measured: From the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Phase Ia: Pharmacokinetics of AZD0305: Maximum plasma concentration of the study drug (Cmax)
Maximum observed plasma concentration of the study drug
Measured: From the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Phase Ia: Pharmacokinetics of AZD0305: Time to maximum plasma concentration of the study drug (tmax)
Time to maximum observed plasma concentration of the study drug
Measured: From the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Phase Ia: Pharmacokinetics of AZD0305: Clearance
A pharmacokinetic measurement of the volume of plasma from which the study drug is completely removed per unit time
Measured: From the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Phase Ia: Pharmacokinetics of AZD0305: Terminal elimination half-life (t 1/2)
Terminal elimination half-life
Measured: From the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Phase Ia: Immunogenicity of AZD0305
The number and percentage of participants who develop ADAs
Measured: From the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Phase Ia: Immunogenicity of elranatamab
The number and percentage of participants who develop ADAs
Measured: From the first dose, at predefined intervals until Cycle 24 administration of elranatamab(approximately 2 years)
Phase Ia: MRD negative CR rate
The percentage of patients who achieve a complete response (CR) and have minimal residual disease (MRD) negativity in bone marrow.
Measured: From first dose of AZD0305 to progressive disease or death in the absence of disease progression (approximately 2 years)
Phase Ib: Objective Response Rate (ORR)
The percentage of patients with a confirmed investigator assessed sCR, CR, VGPR or PR according to IMWG criteria
Measured: From randomization/cohort assignment to progressive disease or Initiation of subsequent MM therapy (approximately 2 years)
Phase Ib: Duration of response (DoR)
The time from date of first response until date of disease progression or death in the absence of disease progression
Measured: From randomization/cohort assignment to confirmed progressive disease or death (approximately 2 years)
Phase Ib: Progression free Survival (PFS)
The time from randomization until IMWG defined disease progression or death
Measured: From randomization/cohort assignment to progressive disease or death in the absence of disease progression (approximately 2 years)
Phase Ib: Overall Survival (OS)
The time from randomization until death due to any cause
Measured: From randomization/cohort assignment to death (approximately 2 years)
Phase Ib: Pharmacokinetics of AZD0305: Area Under the concentration-time curve (AUC)
Area under the plasma concentration-time curve
Measured: From randomization/cohort assignment , at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Phase Ib: Pharmacokinetics of AZD0305: Maximum plasma concentration of the study drug (Cmax)
Maximum observed plasma concentration of the study drug
Measured: From randomization/cohort assignment , at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Phase Ib: Pharmacokinetics of AZD0305: Time to maximum plasma concentration of the study drug (tmax)
Time to maximum observed plasma concentration of the study drug
Measured: From randomization/cohort assignment , at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Phase Ib: Pharmacokinetics of AZD0305: Clearance
A pharmacokinetic measurement of the volume of plasma from which the study drug is completely removed per unit time
Measured: From randomization/cohort assignment , at predefined intervals throughout the administration of AZD0305 (approximately 2 years
Phase Ib: Pharmacokinetics of AZD0305: Terminal elimination half-life (t 1/2)
Terminal elimination half-life
Measured: From randomization/cohort assignment, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Phase Ib: Immunogenicity of AZD0305
The number and percentage of participants who develop ADAs
Measured: From randomization/cohort assignment, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Phase Ib: Immunogenicity of elranatamab
The number and percentage of participants who develop ADAs
Measured: From the first dose, at predefined intervals until Cycle 24 administration of elranatamab(approximately 2 years)
Phase 1b: MRD negative CR rate
The percentage of patients who achieve a complete response (CR) and have minimal residual disease (MRD) negativity in bone marrow.
Measured: From first dose of AZD0305 to progressive disease or death in the absence of disease progression (approximately 2 years)
Complete Response Rate (CRR) - Mod2&3 only
Percentage of participants achieving a confirmed CR or sCR per IMWG criteria.
Measured: From first dose of combination treatment to progressive disease or initiation of subsequent multiple myeloma therapy (approximately 2 years)
Pre-Dose Plasma Concentration of Elranatamab (pharmacokinetics - Module 2 only)
Pre-dose Plasma concentrations for elranatamab.
Measured: From the first dose of study intervention, at predefined intervals until Cycle 24 administration of elranatamab(approximately 2 years; 1 cycle = 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start5 Dec 2023
- Primary completion16 Aug 2027 (estimated)
- Study completion16 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- This protocol has a modular design, with 3 treatment arms/modules. Module 1 will include Phase Ia (Dose escalation), and Phase Ib (Dose expansion/optimization). Module 2 will evaluate AZD0305 in combination with elranatamab at selected dose levels. Module 3 will evaluate AZD0305 in combination with pomalidomide and dexamethasone at selected dose levels.
- Masking
- None (open label)
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106945
- Sponsor's protocol ID
- D7230C00001
- Other IDs
- 2023-508590-89-00, 2023
- Status last verified
- Aug 2026
- First submitted
- 11 Oct 2023
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Modular Phase I/II, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0305 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06106945
- Acronym / sponsor ID
- D7230C00001
- Conditions
- Multiple Myeloma
- Keywords
- GPRC5D, ADC, AZD0305, Multiple Myeloma, MM, MMAE
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 16 Aug 2027 (estimated)
- Study completion
- 16 Aug 2027 (estimated)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 efficacy of AZD0305 as monotherapy and in combination with other anticancer agents in participants with MM.
Detailed description
This study will follow a modular protocol design evaluating AZD0305 as monotherapy and in combination with other anticancer agents. The protocol may be amended in the future to incorporate further monotherapy expansion at the recommended Phase 2 dose (RP2D) in Phase II, and/or additional modules investigating AZD0305 in combination with other anticancer agents.
The study consists of 3 modules:
- Module 1 (AZD0305 monotherapy),
- Module 2 (AZD0305 in combination with elranatamab)
- Module 3 (AZD0305 in combination with pomalidomide and dexamethasone [Pd])
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This protocol has a modular design, with 3 treatment arms/modules. Module 1 will include Phase Ia (Dose escalation), and Phase Ib (Dose expansion/optimization). Module 2 will evaluate AZD0305 in combination with elranatamab at selected dose levels. Module 3 will evaluate AZD0305 in combination with pomalidomide and dexamethasone at selected dose levels.
| Arm | Type | Receives |
|---|---|---|
| AZD0305 monotherapy | Experimental | Drug: AZD0305Module 1: Phase Ia: Dose Escalation Phase Ib: Dose Expansion/Optimization AZD0305 will be administered at specified dose levels. |
| AZD0305 + Elranatamab | Experimental | Drug: AZD0305, Drug: ElranatamabModule2: Phase 1a: Dose escalation and Phase 1b: Backfills, AZD0305 will be administered in combination with elranatamab, following the module-specific dosing. |
| AZD0305 + Pomalidomide and Dexamethasone | Experimental | Drug: AZD0305, Drug: Pomalidomide, Drug: DexamethasoneModule3: Phase 1a: Dose escalation and Phase 1b: Backfills, AZD0305 will be administered in combination with pomalidomide and dexamethasone, following the module-specific dosing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 performance status of ≤ 2 in module 1, or 0 or 1 in modules 2 and 3;
- 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 measurable disease criteria for Serum M-Protein, Urine M-protein, and Serum immunoglobulin free light chains as specified in the relevant module of the CSP;
Key exclusion criteria (15 listed)
- Amyloidosis, plasma cell leukemia, Waldenstrom Macroglobulinemia, Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin Syndrome, or Smoldering Multiple Myeloma (compliant with WHO criteria);
- Participants exhibiting clinical signs of central nervous system involvement of MM;
- Participants with known COPD, or previous history of ILD/pneumonitis;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD0305AZD0305 Investigational product | Drug | AZD0305 + Elranatamab, AZD0305 + Pomalidomide and Dexamethasone, AZD0305 monotherapy |
| ElranatamabModule 2 Investigational product | Drug | AZD0305 + Elranatamab |
| PomalidomideModule 3 Standard of Care (background treatment) | Drug | AZD0305 + Pomalidomide and Dexamethasone |
| DexamethasoneModule 3 Standard of Care (background treatment) | Drug | AZD0305 + Pomalidomide and Dexamethasone |
Primary outcome
Occurrence of dose-limiting toxicity (DLT), as defined in the protocol (Phase Ia dose escalation only)
Time frame: From first dose of AZD0305 until the end of Cycle 1. Cycle 1 (the DLT assessment period is 21 days for Module 1 Group A and 28 days for Module 1 Group B, Module 2, and Module 3)
A DLT is any toxicity occuring from the first dose of AZD0305 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
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
Frequency of dose modifications, dose delays, and treatment discontinuations due to AEs (Module 2 and Module 3)
Time frame: From first dose of study treatment until End of treatment (EOT), assessed up to approximately 2 years (each cycle is 28 days)
Number and percentage of participants with dose modifications, dose delays, and permanent discontinuations due to adverse events (for AZD0305 and combination agent[s], as applicable), per protocol-defined dose modification rules.
26 secondary outcomes
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)
Phase Ia: Duration of response (DoR)
Time frame: From the first documented response to confirmed progressive disease or death (approximately 2 years)
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)
Phase Ia: Overall Survival (OS)
Time frame: From first dose of AZD0305 to death (approximately 2 years)
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)
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)
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)
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)
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)
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)
Phase Ia: Immunogenicity of elranatamab
Time frame: From the first dose, at predefined intervals until Cycle 24 administration of elranatamab(approximately 2 years)
Phase Ia: MRD negative CR rate
Time frame: From first dose of AZD0305 to progressive disease or death in the absence of disease progression (approximately 2 years)
Phase Ib: Objective Response Rate (ORR)
Time frame: From randomization/cohort assignment to progressive disease or Initiation of subsequent MM therapy (approximately 2 years)
Phase Ib: Duration of response (DoR)
Time frame: From randomization/cohort assignment to confirmed progressive disease or death (approximately 2 years)
Phase Ib: Progression free Survival (PFS)
Time frame: From randomization/cohort assignment to progressive disease or death in the absence of disease progression (approximately 2 years)
Phase Ib: Overall Survival (OS)
Time frame: From randomization/cohort assignment to death (approximately 2 years)
Phase Ib: Pharmacokinetics of AZD0305: Area Under the concentration-time curve (AUC)
Time frame: From randomization/cohort assignment , at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Phase Ib: Pharmacokinetics of AZD0305: Maximum plasma concentration of the study drug (Cmax)
Time frame: From randomization/cohort assignment , at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Phase Ib: Pharmacokinetics of AZD0305: Time to maximum plasma concentration of the study drug (tmax)
Time frame: From randomization/cohort assignment , at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Phase Ib: Pharmacokinetics of AZD0305: Clearance
Time frame: From randomization/cohort assignment , at predefined intervals throughout the administration of AZD0305 (approximately 2 years
Phase Ib: Pharmacokinetics of AZD0305: Terminal elimination half-life (t 1/2)
Time frame: From randomization/cohort assignment, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Phase Ib: Immunogenicity of AZD0305
Time frame: From randomization/cohort assignment, at predefined intervals throughout the administration of AZD0305 (approximately 2 years)
Phase Ib: Immunogenicity of elranatamab
Time frame: From the first dose, at predefined intervals until Cycle 24 administration of elranatamab(approximately 2 years)
Phase 1b: MRD negative CR rate
Time frame: From first dose of AZD0305 to progressive disease or death in the absence of disease progression (approximately 2 years)
Complete Response Rate (CRR) - Mod2&3 only
Time frame: From first dose of combination treatment to progressive disease or initiation of subsequent multiple myeloma therapy (approximately 2 years)
Pre-Dose Plasma Concentration of Elranatamab (pharmacokinetics - Module 2 only)
Time frame: From the first dose of study intervention, at predefined intervals until Cycle 24 administration of elranatamab(approximately 2 years; 1 cycle = 28 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Multiple Myeloma
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
RecruitingPhase 1
Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Relapsed Multiple Myeloma, Refractory Multiple Myeloma
RecruitingPhase 1
A Study to Learn About the Effects of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects
Multiple Myeloma (MM)
Active, not recruiting
Real World Treatment Experience of Patients With Breast, Lung, or GI Cancer or Multiple Myeloma Using Remote Symptom Monitoring
Breast Cancer, Lung Cancer
RecruitingPhase 3
A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
Relapsed or Refractory Multiple Myeloma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
43 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AZD0305, Elranatamab and Pomalidomide in people with Multiple Myeloma, run by AstraZeneca at 43 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Germany, Canada, Spain, Australia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of dose-limiting toxicity (DLT), as defined in the protocol (Phase Ia dose escalation only) (time frame: From first dose of AZD0305 until the end of Cycle 1. Cycle 1 (the DLT assessment period is 21 days for Module 1 Group A and 28 days for Module 1 Group B, Module 2, and Module 3)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.