Friday, July 10, 2026

pharma · Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) · Advanced Solid Tumor

Daiichi Sankyo US

Daiichi Sankyo US is a pharma organization headquartered in basking ridge, USA. Primary therapeutic focus areas include Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC), Advanced Solid Tumor, No medical conditio

211 Mt. Airy Road Basking Ridge, Basking Ridge, NJ 07920, US HQ
4,386 Employees
NMPA registrant Type
Company details
Status
Public
HQ
211 Mt. Airy Road Basking Ridge, Basking Ridge, NJ 07920, US
Employees
4,386
Programs
58
Drugs
66
Patents
0
Clinical program

DS3201-324

Phase 1 · small molecule · 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.

DS3201-324 for 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. is a Phase 1 program (small_molecule) at Daiichi Sankyo with 1 ClinicalTrials.gov record(s).

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Internal code DS3201-324

Full intelligence profile for this program is being prepared.

At a glance

Sponsor
Daiichi Sankyo
Phase
Phase 1
Modality
small_molecule
Indication
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.
Status
active
Trials
1