Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2+ Gastric Cancer (DESTINY-Gastric03)
Status:
Recruiting
Trial end date:
2023-07-14
Target enrollment:
Participant gender:
Summary
DESTINY-Gastric03 will investigate the safety, tolerability, pharmacokinetics,
immunogenicity, and preliminary antitumor activity of trastuzumab deruxtecan (T-DXd) alone or
in combination with chemotherapy and/or immunotherapy in HER2-positive advanced/metastatic
gastric/gastroesophageal junction (GEJ) and esophageal adenocarcinoma patients.
Study hypotheses: Combination of T-DXd with cytotoxic chemotherapy and/or immunotherapy
administered to subjects at the recommended phase 2 dose will show manageable safety and
tolerability and preliminary anti-tumor efficacy so as to permit further clinical testing.
T-DXd in combination with cytotoxic chemotherapy or immune checkpoint inhibitor administered
to HER2-positive gastric, GEJ and esophageal cancer patients who have not received prior
treatment for advanced/metastatic disease will show preliminary evidence of anti-tumour
activity and the potential to become a therapeutic option for this patient population.
Phase:
Phase 2
Details
Lead Sponsor:
AstraZeneca
Collaborator:
Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo