Sacituzumab Tirumotecan (Sac-TMT/SKB264) Plus Tagitanlimab (KL-A167) in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma and Gastric/Gastroesophageal Junction Adenocarcinoma

This is a single-arm, multi-center phase II study to evaluate the efficacy and safety of sacituzumab tirumotecan (Sac-TMT/SKB264) combined with tagitanlimab (KL-A167) as 2nd line therapy for recurrent or metastatic esophageal squamous cell carcinoma (ESCC) or gastric/gastroesophageal junction adenocarcinoma (G/GEJA). A total of 75 participants are planned to be enrolled with 10 in the safety lead-in phase and 33 ESCC and 42 G/GEJA in expansion phase, seperately.

NCT Number	NCT07701681
Lead Sponsor	Sun Yat-sen University
Conditions	ESCC, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Squamous Cell Carcinoma (ESCC), GC/GEJC
Enrollment	75 participants
Start Date	2026-08-31
Primary Completion	2028-09-01 (estimated)
Study Completion	2029-09-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-14