Sac-TMT Combined With Fruquintinib as Second-Line Treatment in Patients With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT07689292
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Gastric Adenocarcinoma
  • Gastro-esophageal Junction Adenocarcinoma
  • Gastroesophageal Junction (GEJ) Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Sacituzumab Tirumotecan + Fruquintinib — DRUG
    Sac TMT: 4mg/kg Q2W, IV Infusion Fruquinitinib: 3mg QD PO, d1-21, Q4W

Study Details

This is a phase 2 multicenter study that will evaluate the safety and efficacy of sacituzumab tirumotecan (Sac-TMT) plus fruquintinib for the treatment of participants with locally advanced or metastatic gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma who have failed 1 prior line of therapy.

Key Dates

First listed
Jul 8, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2027
Completion
Dec 31, 2028

Study Design

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

Arms

  • Experimental: Sac TMT + Fruquintinib
    Following a 21 day run-in with sacituzumab tirumotecan at 4 mg/kg IV infusion on day 1 of a 2-week cycle plus fruquintinib at 3 mg QD PO on days 1-21 of a 4-week cycle, participants receive sacituzumab tirumotecan at 4 mg/kg IV infusion on day 1 of a 2-week cycle plus fruquintinib at 3 mg QD PO on days 1-21 of a 4-week cycle until discontinuation.

Primary Outcome Measure

Percentage of Participants who Experience Dose Limiting Toxicities (DLTs) During the Safety Lead-In Phase [ Time Frame: Up to ~21 days ]

Central Contacts

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