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AZD3470 as Monotherapy and in Combination With Anticancer Agents in Participants With Relapsed/Refractory Haematologic Malignancies.
PHASE1PHASE2RECRUITING
This study is designed to evaluate the safety, tolerability, PK and preliminary efficacy following oral administration of AZD3470 as a monotherapy, and in combination with other anticancer agents in participants with haematologic malignancies.
Study details:
This is a FTiH modular, Phase I/II, open-label, multicentre, dose escalation and expansion study in participants with r/r haematologic malignancies. The study is designed to evaluate the safety, tolerability, PK and preliminary efficacy following oral administration of AZD3470 as a monotherapy, and in combination with other anticancer agents in participants with haematologic malignancies. This study will follow a modular protocol design evaluating AZD3470 as monotherapy and in combination with other anticancer agents.
New cohorts (including further monotherapy expansion) and new modules for combination treatments may be added as protocol amendments in the future based on emerging supportive preclinical and/or clinical data. Module 1 Part A includes a dose escalation of AZD3470 monotherapy in participants with r/r haematologic malignancies, initially focused on r/r cHL. Dose escalation cohorts will evaluate the safety, tolerability, PK, and preliminary efficacy in participants with r/r cHL.
Module 1 Part B optimization/expansion cohorts may be opened at selected dose levels. These cohorts will further characterise the safety, PK, and preliminary efficacy of AZD3470 to support dose optimization. Both adult and adolescent participants with r/r cHL will be eligible for this part of the study.
Adolescent participants will only be enrolled once there is sufficient PK and safety data in adults. A preliminary effect of food on AZD3470 pharmacokinetics will be explored in this part of the study. The protocol may be amended in the future to incorporate further expansion of cHL at the RP2D, additional monotherapy cohorts in other hematologic malignancies, and/or additional modules investigating AZD3470 in combination with other anticancer agents.
Eligibility criteria
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Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 15 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-01-23
Primary completion: 2026-05-08
Study completion finish: 2026-05-08
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT06137144
Intervention or treatment
DRUG: AZD3470
Conditions
- • Lymphoma
- • Non-Hodgkin
- • Hodgkin Lymphoma
Find a site
Closest Location:
Research Site
Research sites nearby
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Research Site
Nedlands, Not Specified, Australia
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Module 1: Part A (Dose Escalation) and Part B (Dose Expansion/Optimization)
| DRUG: AZD3470
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | AEs: Number of patients with adverse events by system organ class and preferred term. SAEs: Number of patients with serious adverse events by system organ class and preferred term. | From Screening until 28 days after the last dose of study medication. |
| Incidence of DLTs (Dose Escalation only) | In the Dose Escalation cohorts in Part A, the number of participants with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol. | From first dose of AZD3470 to end of Cycle 1 (each cycle is 21 days). |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Part A and Part B: Response endpoints - Objective Response Rate (ORR)/Complete Response Rate (CRR) | ORR is defined as the proportion of participants who have a CR or PR and CRR is defined as the proportion of participants who have a CR. Assessment of ORR/CRR will be done according to the Lugano Classification for cHL. | From first dose (Cycle 1 Day 1, each cycle is 21 days) until disease progression or the last evaluable assessment in the absence of progression (assessed approximately up to 2 years). |
| Part A and Part B: Response endpoints - Duration of Response (DoR) | The time from the date of first documented response until the date of documented progression as assessed by the investigator according to the Lugano classification for cHL, or death due to any cause. | From first dose (Cycle 1 Day 1, each cycle is 21 days) until disease progression or death, whichever comes first (assessed approximately up to 2 years). |
| Part A and Part B: Progression-free Survival (PFS) | Time from date of first dose (non- randomised study parts) or date of randomization (randomised study parts) until progression as assessed by the investigator according to the Lugano Classification for cHL, or death due to any cause. | Non-randomized study parts: from first dose (each cycle is 21 days) until disease progression or death, whichever comes first. Randomized parts: from date of randomization until disease progression or death, whichever comes first (approx up to 2 years). |
| Part A and Part B: Overall Survival (OS) | Time from date of first dose (non-randomised study parts) or date of randomization (randomised study parts) until the date of death due to any cause. | Non-randomized study parts: From first dose (Cycle 1 Day 1, each cycle is 21 days) until death. Randomized study parts: from date of randomization until the date of death due to any cause (assessed approximately up to 2 years). |
| Part A and Part B: Maximum observed plasma drug concentration (Cmax) | Assessed to characterize the plasma PK profile of AZD3470. | From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months). |
| Part A: Dose normalised maximum observed plasma drug concentration (Cmax) | Assessed to characterize the plasma PK profile of AZD3470. | From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months). |
| Part A: Accumulation ratio for maximum observed plasma drug concentration (Cmax) | Assessed to characterize the plasma PK profile of AZD3470. | From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months). |
| Part A and Part B: Minimum observed plasma drug concentration (Cmin) | Assessed to characterize the plasma PK profile of AZD3470. | From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months). |
| Part A and Part B: Time to reach peak or maximum observed concentration following drug administration (Tmax) | Assessed to characterize the plasma PK profile of AZD3470. | From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months). |
| Part A and Part B: Area under the plasma concentration-curve over the dosing interval (AUCtau) | Assessed to characterize the plasma PK profile of AZD3470. | From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months). |
| Part A: Dose normalized area under the plasma concentration-curve over the dosing interval (AUCtau) | Assessed to characterize the plasma PK profile of AZD3470. | From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months). |
| Part A: Accumulation ratio for area under the plasma concentration-curve over the dosing interval (AUCtau) | Assessed to characterize the plasma PK profile of AZD3470. | From Cycle 1 Day 1 (each cycle is 21 days) to EoT, at predefined intervals throughout the treatment period (for each patient this is expected to be approximately 6 months). |
| Part A: Cumulative amount (%) of drug recovered unchanged in urine during dosing interval (Ae,tau) | Assessed to characterize the urine PK profile of AZD3470. | From Cycle 1 Day 1 to end of Cycle 1 at predefined intervals throughout the cycle (each cycle is 21 days). |
| Part A: Renal clearance (Clr) | Assessed to characterize the urine PK profile of AZD3470. | From Cycle 1 Day 1 to end of Cycle 1 at predefined intervals throughout the cycle (each cycle is 21 days). |
| Part B: Ratio of maximum observed plasma drug concentration (Cmax) under fed/fasted state | Preliminary food effect on plasma PK of AZD3470 administered as a monotherapy in participants enrolled in dose expansion. | From Cycle 1 Day 1 to Cycle 2 Day 1 at predefined intervals (each cycle is 21 days). |
| Part B: Time to reach peak or maximum observed concentration following drug administration (Tmax) under fed conditions | Preliminary food effect on plasma PK of AZD3470 administered as a monotherapy in participants enrolled in dose expansion. | From Cycle 1 Day 1 to Cycle 2 Day 1 at predefined intervals (each cycle is 21 days). |
| Part B: Time to reach peak or maximum observed concentration following drug administration (Tmax) under fasted conditions | Preliminary food effect on plasma PK of AZD3470 administered as a monotherapy in participants enrolled in dose expansion. | From Cycle 1 Day 1 to Cycle 2 Day 1 at predefined intervals (each cycle is 21 days). |
| Part B: Ratio of area under the plasma concentration-curve over the dosing interval (AUCtau) under fed/fasted state | Preliminary food effect on plasma PK of AZD3470 administered as a monotherapy in participants enrolled in dose expansion. | From Cycle 1 Day 1 to Cycle 2 Day 1 at predefined intervals (each cycle is 21 days). |
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