A modular Phase I/II, open-label, multi-center study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of AZD4512 monotherapy or in combination with anticancer agent(s) in participants with Acute Lymphoblastic Leukemia

Condition studied

B-cell acute lymphoblastic leukemia (B-ALL)

Investigational medicinal product(s)

Eligibility

Primary endpoint

Module 1 Dose Escalation: Safety and Tolerability of AZD4512 -Assessment of DLT -Assessment of TEAEs/TRAEs/SAEs -Interruptions, modifications, delays and discontinuations -Clinically significant changes from baseline, Module 1 Dose Escalation: Determine the MTD and/or doses to explore in Module 2, Module 2 Dose Optimization: Antitumour activity and determine the RP2D of AZD4512 -Response Rate: ORR (CR/CRh), Module 2 Dose Optimization:Safety and Tolerability of AZD4512 -Assessment of TEAEs/TRAEs/SAEs -Interruptions, modifications, delays and discontinuations -Clinically significant changes from baseline

Endpoint detail

Module 1 Dose Escalation: Characterize AZD4512 PK as monotherapy, Module 1 Dose Escalation: Immunogenicity as monotherapy -ADA development, Module 1 Dose Escalation: Preliminary Antitumour Activity of AZD4512 -Response Rate: ORR (CR/CRh), CR and CRc rate, TTR, DoR, EFS, OS, subsequent HSCT, Module 2 Dose Optimization: Antitumour Activity of AZD4512 -Response Rate: CR and CRc rate, TTR, DoR, EFS, OS, subsequent HSCT, Module 2 Dose Optimization: Effect of AZD4512 on MRD (NGS) -MRD-negative CR rate, CR/CRh (ORR), CRc (CR/CRi/CRh) rate, Module 2 Dose Optimization: PK of AZD4512 as monotherapy, Module 2 Dose Optimization: Immunogenicity as monotherapy -ADA development