NCT07609667

Brief Summary

This study is a multicenter,open-label,randomized, phase II clinical study conducted in China. The purpose of this study is to evaluate the efficacy of SKB315 plus PD-1 inhibitor ±capecitabine in patients with Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
37mo left

Started Jun 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 27, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 30, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

May 27, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

May 20, 2026

Last Update Submit

May 20, 2026

Conditions

Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate (ORR)

    The sum of the number of cases with Complete Response (CR) and Partial Response (PR) in all treated tumor patients (CR + PR) divided by the total number of cases.

    up to 2 years

Secondary Outcomes (6)

  • Duration of Response (DOR)

    up to 2 years

  • Progression Free Survival (PFS)

    up to 2 years

  • Overall Survival (OS)

    up to 2 years

  • Safety and tolerability assessed by adverse events (AEs)

    Until 90 days after the end of treatment

  • Time to Response (TTR)

    up to 2 years

  • +1 more secondary outcomes

Study Arms (2)

SKB315+Tislelizumab

EXPERIMENTAL

SKB315+Tislelizumab

Drug: TislelizumabDrug: SKB315 for injection

SKB315+Tislelizumab+capecitabine

EXPERIMENTAL

SKB315+Tislelizumab+capecitabine

Drug: TislelizumabDrug: SKB315 for injectionDrug: Capecitabine

Interventions

TislelizumabDRUG

Tislelizumab will be administered as the protocol described

SKB315+TislelizumabSKB315+Tislelizumab+capecitabine
SKB315 for injectionDRUG

Tislelizumab will be administered as the protocol described

SKB315+TislelizumabSKB315+Tislelizumab+capecitabine
CapecitabineDRUG

Capecitabine will be taken orally as the protocol described

SKB315+Tislelizumab+capecitabine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Locally advanced unresectable or metastatic gastric cancer (GC) or gastroesophageal junction (GEJ) carcinoma and have histologically confirmed adenocarcinoma
  • No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer.
  • Consent to provide archival or fresh tumor tissue slides for immunohistochemistry (IHC) assessment, and advanced solid tumors with Claudin 18.2 and PD-L1 expression as determined by IHC;
  • Presence of at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
  • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;
  • Estimated survival ≥ 3 months as judged by the investigator;
  • Adequate organ and bone marrow function (no blood components and cytokines are allowed within 2 weeks prior to the first dose) ;
  • Patients of childbearing potential (male or female) must use effective medical contraception during the study and for 6 months after the end of dosing;

You may not qualify if:

  • Active leptomeningeal disease or uncontrolled brain metastasis
  • Diagnosed with gastric or GEJ adenocarcinoma with positive HER2
  • Received other drugs in clinical study, major surgeries, or any other antitumor therapies within 4 weeks prior to the first dose of study treatment;
  • Patients with active hepatitis B or hepatitis C;
  • Patients have significant gastric bleeding
  • The presence of clinically uncontrollable third interspace fluid
  • Have clinically significant systemic diseases that may adversely affect the safety of the study;
  • Patients who may have poor compliance with the clinical study or have other factors based on which the investigator considers that the patients are not appropriate to patients in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Location

MeSH Terms

Interventions

tislelizumabInjectionsCapecitabine

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Yi Ba, professor

    Peking Union Medical College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Ba Professor

CONTACT

010-69158370bayi@tjmuch.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2026

First Posted

May 27, 2026

Study Start (Estimated)

June 30, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2029

Last Updated

May 27, 2026

Record last verified: 2026-05

Locations

CN(1)