Gastroesophageal Junction AdenocarcinomaPhase 2SKB315NCT07609667
SKB315 in Combination Therapy in Patients With Advanced or Metastatic GC/ GEJ Adenocarcinoma
A Phase 2 study testing Tislelizumab, SKB315 for injection and Capecitabine in people with Gastroesophageal Junction Adenocarcinoma, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Tislelizumab, SKB315 for injection and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2026to 30 Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Yi Ba Professor, 010-69158370, bayi@tjmuch.com
About this study
Official title: A Phase II Study Evaluating the Efficacy and Safety of SKB315 Combination Therapy in Claudin18.2 Positive Patients With Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
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.
- Conditions
- Gastroesophageal Junction Adenocarcinoma
- Being tested
- Tislelizumab, SKB315 for injection, Capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Tislelizumab will be administered as the protocol described
SKB315 for injectionDrug
Tislelizumab will be administered as the protocol described
CapecitabineDrug
Capecitabine will be taken orally as the protocol described
| Study group | Role | What they receive |
|---|---|---|
| SKB315+Tislelizumab | Experimental | SKB315+Tislelizumab Receives: Drug: Tislelizumab; Drug: SKB315 for injection |
| SKB315+Tislelizumab+capecitabine | Experimental | SKB315+Tislelizumab+capecitabine Receives: Drug: Tislelizumab; Drug: SKB315 for injection; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 years
Secondary outcomes (6)
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.
Measured: up to 2 years
Progression Free Survival (PFS)
Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.
Measured: up to 2 years
Overall Survival (OS)
Time from start of treatment to death due to any reason.
Measured: up to 2 years
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.
Measured: Until 90 days after the end of treatment
Time to Response (TTR)
Time from the start of treatment to the first assessment of CR or PR in tumor patients.
Measured: up to 2 years
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.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yi Ba, professor, Principal investigator, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609667
- Sponsor's protocol ID
- SKB315-II-02
- Acronym
- SKB315
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Evaluating the Efficacy and Safety of SKB315 Combination Therapy in Claudin18.2 Positive Patients With Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07609667
- Acronym / sponsor ID
- SKB315 / SKB315-II-02
- Conditions
- Gastroesophageal Junction Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SKB315+Tislelizumab | Experimental | Drug: Tislelizumab, Drug: SKB315 for injectionSKB315+Tislelizumab |
| SKB315+Tislelizumab+capecitabine | Experimental | Drug: Tislelizumab, Drug: SKB315 for injection, Drug: CapecitabineSKB315+Tislelizumab+capecitabine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TislelizumabTislelizumab will be administered as the protocol described | Drug | SKB315+Tislelizumab, SKB315+Tislelizumab+capecitabine |
| SKB315 for injectionTislelizumab will be administered as the protocol described | Drug | SKB315+Tislelizumab, SKB315+Tislelizumab+capecitabine |
| CapecitabineCapecitabine will be taken orally as the protocol described | Drug | SKB315+Tislelizumab+capecitabine |
Primary outcome
Objective Response Rate (ORR)
Time frame: up to 2 years
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.
6 secondary outcomes
Duration of Response (DOR)
Time frame: up to 2 years
Progression Free Survival (PFS)
Time frame: up to 2 years
Overall Survival (OS)
Time frame: up to 2 years
Safety and tolerability assessed by adverse events (AEs)
Time frame: Until 90 days after the end of treatment
Time to Response (TTR)
Time frame: up to 2 years
Disease Control Rate (DCR)
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yi Ba, professor principal investigator
Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab, SKB315 for injection and Capecitabine in people with Gastroesophageal Junction Adenocarcinoma, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Ba Professor (010-69158370, bayi@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.