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Not yet recruitingNCT07609667SKB315Updated May 27, 2026

SKB315 in Combination Therapy in Patients With Advanced or Metastatic GC/ GEJ Adenocarcinoma

A Phase 2 interventional study of Tislelizumab and SKB315 for injection in Gastroesophageal Junction Adenocarcinoma, sponsored by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-27.

Sponsored by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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

Read the detailed description

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

This study will also evaluate efficacy, physical function, safety, and tolerability of SKB315 combination, as well as Pharmacokinetics (PK) of SKB315 and the immunogenicity profile of SKB315 will be evaluated as well.

02

Conditions studied

  • Gastroesophageal Junction Adenocarcinoma
03

In context

Lead sponsor

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. is the lead sponsor of 55 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Locally advanced unresectable or metastatic gastric cancer (GC) or gastroesophageal junction (GEJ) carcinoma and have histologically confirmed adenocarcinoma
  2. No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer.
  3. 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;
  4. Presence of at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
  5. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;
  6. Estimated survival ≥ 3 months as judged by the investigator;
  7. Adequate organ and bone marrow function (no blood components and cytokines are allowed within 2 weeks prior to the first dose) ;
  8. Patients of childbearing potential (male or female) must use effective medical contraception during the study and for 6 months after the end of dosing;

Exclusion criteria

Exclusion Criteria:

  1. Active leptomeningeal disease or uncontrolled brain metastasis
  2. Diagnosed with gastric or GEJ adenocarcinoma with positive HER2
  3. Received other drugs in clinical study, major surgeries, or any other antitumor therapies within 4 weeks prior to the first dose of study treatment;
  4. Patients with active hepatitis B or hepatitis C;
  5. Patients have significant gastric bleeding
  6. The presence of clinically uncontrollable third interspace fluid
  7. Have clinically significant systemic diseases that may adversely affect the safety of the study;
  8. 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    SKB315+Tislelizumab

    SKB315+Tislelizumab

    Drug: Tislelizumab · Drug: SKB315 for injection

  • Experimental
    SKB315+Tislelizumab+capecitabine

    SKB315+Tislelizumab+capecitabine

    Drug: Tislelizumab · Drug: SKB315 for injection · Drug: Capecitabine

Interventions

  • DrugTislelizumab

    Tislelizumab will be administered as the protocol described

  • DrugSKB315 for injection

    Tislelizumab will be administered as the protocol described

  • DrugCapecitabine

    Capecitabine will be taken orally as the protocol described

06

What researchers measure

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.

    Time frame: up to 2 years

Secondary outcomes

  1. Duration of Response (DOR)

    Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.

    Time frame: up to 2 years

  2. Progression Free Survival (PFS)

    Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.

    Time frame: up to 2 years

  3. Overall Survival (OS)

    Time from start of treatment to death due to any reason.

    Time frame: up to 2 years

  4. Safety and tolerability assessed by adverse events (AEs)

    An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

    Time frame: Until 90 days after the end of treatment

  5. Time to Response (TTR)

    Time from the start of treatment to the first assessment of CR or PR in tumor patients.

    Time frame: up to 2 years

  6. Disease Control Rate (DCR)

    Proportion of patients with best overall response of CR, PR, or SD and without PD or death due to any reason at the time of assessment in tumor patients.

    Time frame: up to 2 years

07

Study locations

1 site
  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
    Beijing, Beijing Municipality, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07609667
Lead sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
May 27, 2026
Start date
Jun 30, 2026 (estimated)
Primary completion
Jun 30, 2028 (estimated)
Completion
Jun 30, 2029 (estimated)
Last update
May 27, 2026

Study contacts

Yi Ba Professor
Contact
bayi@tjmuch.com
010-69158370
Yi Ba, professor
principal investigator · Peking Union Medical College

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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