Trial · NCT06106945
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Occurrence of dose-limiting toxicity (DLT), as defined in the protocol (Phase Ia dose escalation only) | 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 |
| Primary | Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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 |
| Primary | Frequency of dose modifications, dose delays, and treatment discontinuations due to AEs (Module 2 and Module 3) | 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. |
| Secondary | Phase Ia: Objective Response Rate (ORR) | 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 |
| Secondary | Phase Ia: Duration of response (DoR) | 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 |
| Secondary | Phase Ia: Progression free Survival (PFS) | 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 |
| Secondary | Phase Ia: Overall Survival (OS) | 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 |
| Secondary | Phase Ia: Pharmacokinetics of AZD0305: Area Under the concentration-time curve (AUC) | 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 |
| Secondary | Phase Ia: Pharmacokinetics of AZD0305: Maximum plasma concentration of the study drug (Cmax) | 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 |
| Secondary | Phase Ia: Pharmacokinetics of AZD0305: Time to maximum plasma concentration of the study drug (tmax) | 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 |
| Secondary | Phase Ia: Pharmacokinetics of AZD0305: Clearance | 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 |
| Secondary | Phase Ia: Pharmacokinetics of AZD0305: Terminal elimination half-life (t 1/2) | From the first dose of study intervention, at predefined intervals throughout the administration of AZD0305 (approximately 2 years) | Terminal elimination half-life |
| Secondary | Phase Ia: Immunogenicity of AZD0305 | 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 |
| Secondary | Phase Ia: Immunogenicity of elranatamab | From the first dose, at predefined intervals until Cycle 24 administration of elranatamab(approximately 2 years) | The number and percentage of participants who develop ADAs |
| Secondary | Phase Ia: MRD negative CR rate | From first dose of AZD0305 to progressive disease or death in the absence of disease progression (approximately 2 years) | The percentage of patients who achieve a complete response (CR) and have minimal residual disease (MRD) negativity in bone marrow. |
| Secondary | Phase Ib: Objective Response Rate (ORR) | From randomization/cohort assignment 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 |
| Secondary | Phase Ib: Duration of response (DoR) | From randomization/cohort assignment 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 |
| Secondary | Phase Ib: Progression free Survival (PFS) | From randomization/cohort assignment 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 |
| Secondary | Phase Ib: Overall Survival (OS) | From randomization/cohort assignment to death (approximately 2 years) | The time from randomization until death due to any cause |
| Secondary | Phase Ib: Pharmacokinetics of AZD0305: Area Under the concentration-time curve (AUC) | From randomization/cohort assignment , at predefined intervals throughout the administration of AZD0305 (approximately 2 years) | Area under the plasma concentration-time curve |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT06106945/registered