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A Study of AZD3470, a PRMT5 Inhibitor, Given as Monotherapy and in Combination in Patients With MTAP Deficient Advanced/Metastatic Solid Tumors

ConditionAdvanced Solid Tumors That Are MTAP Deficient
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

This is a first time in human (FTiH) Phase I/IIa, open-label, multi-centre study of AZD3470 in participants with advanced or metastatic solid tumors with MTAP deficiency. The study consists of several study modules, evaluating the safety, tolerability, pharmacokinetic (PK), pharmacodynamics, and preliminary efficacy of AZD3470 as monotherapy or in combination with other anti-cancer agents.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • AZD3470

    Drug

    AZD3470 is a novel, potent and selective, second-generation, MTAP-selective, inhibitor of PRMT5.

  • Datopotamab deruxtecan

    Drug

    AZD3470 in combination with Dato-DXd + Dato-Dxd monotherapy

Treatment groups

334 Participants
are divided into 3 treatment groups
Group A: Module 1: AZD3470 MonotherapyExperimental treatment 1 intervention
Group B: Module 2: AZD3470 in combination with Dato-DXdExperimental treatment 2 interventions
Group C: Module 2: Dato-DXd aloneExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

All Modules: Incidence of adverse events (AEs) and serious adverse events (SAEs). To determine the RP2D of AZD3470 as monotherapy and in combination with anticancer agents

Number of participants with AEs and SAEs.

Time frame
From time of informed consent to 28 days post last dose of study treatment
2

Module 1: Incidence of dose-limiting toxicities (DLT)

Incidence of dose-limiting toxicities (DLT) as determined by number of patients with at least 1 dose-limiting toxicity (DLT)

Time frame
From first dose of study treatment until the end of Cycle 1 (each cycle is 21 days)
3

Module 2: Progression Free Survival assessed by the Investigator according to RECIST v1.1

PFS - defined as time from date of randomization until progression per RECIST v1.1 as assessed by the Investigator at local site, or death due to any cause.

Time frame
From date of randomization up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).

Secondary outcomes

1

All modules: Radiological response assessed by the Investigator evaluated according to RECIST v1.1 - ORR (Objective Response Rate)

Proportion of participants who have a complete or partial radiological response as determined by the Investigator according to RECIST v1.1

Time frame
From date of first dose of AZD3470 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).
2

All modules: Radiological response assessed by the Investigator evaluated according to RECIST v1.1 - DoR (Duration of Response)

DoR - the time from date of first documented objective response until date of documented disease progression per Tumor RECIST v1.1 as assessed by the Investigator at local site or death due to any cause.

Time frame
From date of first dose of AZD3470 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).
3

All modules: Radiological response assessed by the Investigator evaluated according to RECIST v1.1 - Best percentage change in tumor size

Best percentage change from baseline in TL (target lesion) tumor size is based on the RECIST 1.1. TL measurements as assessed by the Investigator.

Time frame
From date of first dose of AZD3470 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).
4

Module 1: Progression Free Survival assessed by the Investigator evaluated according to RECIST v1.1

PFS - defined as time from date of first dose (nonrandomized study parts) or date of randomization (randomized study parts) until progression per RECIST v1.1 as assessed by the Investigator at local site, or death due to any cause.

Time frame
From date of first dose/randomization up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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