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

NCT07701681 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-07-14

No results posted yet for this study

Summary

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.

Conditions

  • ESCC
  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma
  • Esophageal Squamous Cell Carcinoma (ESCC)
  • GC/GEJC

Interventions

DRUG

Sacituzumab Tirumotecan + Tagitanlimab

Sac-TMT (SKB264): 4mg/kg, IV infusion on Day 1, Q2W A167: 900 mg via IV injection on day 1, Q2W, up to 2 years

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-09-01
Completion
2029-09-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07701681 on ClinicalTrials.gov