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

Conditions

• Advanced Solid Tumors That Are MTAP Deficient

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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.

Key Dates

Start date

Jan 18, 2024

Status verified

Jun 2026

Primary completion

Dec 4, 2028

Completion

Dec 4, 2028

Study Design

Enrollment

334 participants (estimated)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Module 1: AZD3470 Monotherapy
  Part A dose escalation and back-fill cohorts and Part B dose optimization and expansion cohorts of varying doses of AZD3470
• Experimental: Module 2: AZD3470 in combination with Dato-DXd
  Varying doses of AZD3470 in combination with Dato-Dxd
• Experimental: Module 2: Dato-DXd alone
  Control arm

Primary Outcome Measure

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 [ Time Frame: From time of informed consent to 28 days post last dose of study treatment ]

Central Contacts

• AstraZeneca Clinical Study Information Center
  1-877-240-9479
  [email protected]

Locations (8)

Find similar trials in San Francisco, CA