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

Sponsor
Sun Yat-sen University
Study ID
NCT07701681
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sacituzumab Tirumotecan + Tagitanlimab — DRUG
    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

Study Details

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.

Key Dates

First listed
Jul 14, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Sep 1, 2028
Completion
Sep 1, 2029

Study Design

Enrollment
75 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sac-TMT + A167

Primary Outcome Measure

Safety Lead-in Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to 21 days ]

Central Contacts

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