A phase 1B, multicenter, open-label study of Valemetostat Tosylate in combination with DXd ADCs in subjects with solid tumors(study of Valemetostat Tosylate in combination with DXd ADCs)

This study will be a Phase 1b, global, multicenter, open-label, 2-part study of valemetostat in combination with DXd ADCs. The Master Protocol study design contains independent subprotocols, which have been defined by treatment combination and subject population, as follows: Sub-protocol A: Valemetostat in combination with T-DXd in subjects with previously treated, unresectable and/or metastatic HER2-low (immunohistochemistry[IHC] 1+ or IHC 2+/in situ hybridization [ISH]-negative) BC; for details, see Sub-protocol A. Sub-protocol B: Valemetostat in combination with T-DXd in subjects with previously treated, advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma; for details, see Sub-protocol B. Sub-protocol C: Valemetostat in combination with Dato-DXd in subjects with previously treated, locally advanced, unresectable, or metastatic non-squamous NSCLC with or without actionable genomic alteration(s); for details, see Sub-protocol C.

Number of Participants Reporting Dose-limiting Toxicities (Part 1 Dose Escalation), Number of Participants Reporting Treatmentemergent Adverse Events (Part 1 Dose Escalation), Objective Response Rate Based on Investigator Assessment (Part 2 Dose Expansion)

Overall survival, Progression-free Survival, Duration of Response (DoR), Objective Response Rate Based on Investigator Assessment (Part 1 Dose Escalation), Number of Participants Reporting Treatment-emergent Adverse Events (Part 2 Dose Expansion), Total and Unbound Plasma Concentration of Valemetostat, Plasma Concentration of DXd Antibody-Drug Conjugates

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