Pfizer COVID-19 vaccine appointments are available to our patients. Sign up for Connect today to schedule your vaccination.

Phase 1/1B Study of DS-8201a in Combination with ATR Inhibition (AZD6738) in Advanced Solid Tumors with HER2 Expression (DASH Trial)

Clinical Trial Details

This study is being done to determine the highest dose of AZD6738 that can safely be taken in combination with DS-8201a and what effect will this combination have on DNA repair mechanisms in advanced colorectal or gastroesophageal cancer.

There are two parts in this study, a dose escalation part, and a dose expansion part. The study doctor will tell each participant what part they are in.

In the dose escalation part of the study, participants will receive 3-week cycles of DS-8201 and AZD6738(ceralasertib). The combination of AZD6738 (ceralasertib) and DS-8201a is not approved by the U.S. Food and Drug Administration (FDA) for the treatment of colorectal or gastroesophageal cancer, however DS-8201a is approved by the FDA as treatment of breast or gastric cancer that expresses a gene or protein called HER2. DS-8201a is given intravenously while AZD6738 (ceralasertib) is taken orally.

In the dose expansion part of the study, participants will either receive a combination of DS-8201a and AZD6738 (ceralasertib) every 3-weeks, or DS-8201a alone for one 3-week cycle and then a combination of DS-8201a and AZD6738 (ceralasertib) after that.

In both parts of the study, DS-8201a is given intravenously while AZD6738 (ceralasertib) is taken orally.

Participants will receive treatment until their cancer grows, they develop unmanageable side-effects, or they withdraw from the study.

Key Eligibility: 
  •  Open to men and women aged 18 or older who have a confirmed diagnosis of advanced/metastatic gastroesophageal cancer or colorectal cancer. 
  • Participants must have HER2-positive or HER2-expressing tumors
  • Participants must have received at least one line of systemic chemotherapy

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan


Carina Puello, RN
(646) 962-3541

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:






Open to Enrollment