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AZD3470 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Haematologic Malignancies.

ConditionsLymphomaNon-Hodgkin LymphomaHodgkin LymphomaPeripheral T-cell Lymphoma (PTCL)PTCL-NOSALCLAITL
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorAstraZeneca

About this trial

This study is designed to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy following oral administration of AZD3470 as a monotherapy, and in combination with other anticancer agents in participants with haematologic malignancies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adequate adult (ECOG) or adolescent (Karnofsy or Lanksy) Performance Score assessments

Adequate organ and bone marrow function.

Part A (dose escalation): aged ≥ 18 years at the time of signing the informed consent.

Part B (optimization): aged ≥ 12 years of age. Adolescent participants must weigh ≥ 40 kg.

Disqualifiers

Any significant laboratory finding or any severe and uncontrolled medical condition.

Active CNS involvement by lymphoma, leptomeningeal disease, or spinal cord compression.

Serologic active HBV or HCV infection.

Known to have tested positive for HIV.

Trial design

Design model

Sequential

Treatments tested in this trial

  • AZD3470

    Drug

    AZD3470 is a novel, potent and selective, second-generation, Methylthioadenosine (MTA)-selective, small molecule inhibitor of PRMT5.

  • Pembrolizumab

    Drug

    Pembrolizumab (CAS nr: 1374853-91-4 )

Treatment groups

161 Participants
are divided into 2 treatment groups
Group A: AZD3470 MonotherapyExperimental treatment 1 intervention
Group B: AZD3470 in combination with PembrolizumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From Screening continuously until 28 days after the last dose of study medication.
2

Incidence of DLTs (Dose Escalation Cohorts 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.

Time frame
From first dose of AZD3470 to end of Cycle 1 (each cycle is 21 days).

Secondary outcomes

1

Response endpoints as assessed by the investigator according to the Lugano Classification: Objective Response Rate (ORR)/Complete Response Rate (CRR)

Applicable to Module 1 Cohort 1 and 3, and Module 2 Cohort 1: 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 and PTCL

Time frame
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.
2

Response Endpoints as assessed by investigator according to the Lugano Classification: Conversation rate of Partial Response (PR) to Complete Response (CR)

Applicable to Module 1 Cohort 2: PR to CR conversion rate is defined as the proportion of participants who have a PR at baseline after induction therapy, who subsequently achieve a CR. PR and CR are assessed by investigators according to Lugano classification for lymphoma.

Time frame
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.
3

Response endpoints as assessed by the investigator according to the Lugano Classification: Duration of Response (DoR)

Applicable to Module 1 Cohort 1 and Cohort 3 and Module 2 Cohort 1: For the patients who have achieved an objective response (CR or PR), 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 and PTCL, or death due to any cause (in absence of disease progression).

Time frame
From date of first objective response until documented progression or death due to any cause or censoring (if progression or death have not occurred)
4

Response endpoints as assessed by the investigator according to the Lugano Classification for CHL: The rate of durable CR

Applicable to Module 2 Cohort 1: Rate of durable complete response is defined as the proportion of participants who have a CR with a duration according to CSP-defined timelines.

Time frame
From date of first complete response until documented progression or death due to any cause or censoring (if progression or death have not occurred)

Other outcomes

Sponsors and contacts

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AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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