Advanced Solid TumorsPhase 1NCT05367635
A Study of SKB315 in Patients With Advanced Solid Tumors
A Phase 1 study testing SKB315 for injection and Drug: Tagitanlimab Drug: Capecitabine in people with Advanced Solid Tumors, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, open-label, multiple-dose dose finding and expansion study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and anti-tumor efficacy of SKB315 for injection in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- SKB315 for injection and Drug: Tagitanlimab Drug: Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2022to 30 Jun 2028
- Phase
- Phase 1
- 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
- Ia\&Ib(monotherapy):1) Male or female patients aged 18 to 80 years (inclusive) at the time of signing the informed consent form (ICF); 2) Patients with histologically and/or cytologically confirmed advanced solid tumors who have failed standard of care, or who have no available standard of care regimen, or who are unqualified for standard of care; 3) Consent to provide archival or fresh tumor tissue slides for immunohistochemistry (IHC) assessment, and advanced solid tumors with Claudin 18.2 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) Have recovered to ≤ Grade 1 (according to national cancer institute (NCI) common terminology criteria adverse events (CTCAE) V5.0) from previously treated toxicity prior to the first dose of study treatment; 9) Patients of childbearing potential (male or female) must use effective medical contraception during the study and for 6 months after the end of dosing; 10) Patients voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol-specified visits and relevant procedures.
- Phase Ib (combination) Inclusion criteria
- Age 18 to 80 years old (including boundary values);
- Histopathologically confirmed unresectable locally advanced, recurrent, or metastatic adenocarcinoma of the gastric and gastroesophageal junction 3 positive CLDN18.2 expression in tumor tissue;
- 4. ECOG score 0-1; 5. Expected survival ≥3 months; 6. There is at least one measurable lesion that meets the RECIST 1.1 criteria; 7. Adequate bone marrow and organ function
Who cannot join
- Ia\&Ib(monotherapy)1) Received other drugs in clinical study, major surgeries, or any other anti-tumor therapies within 4 weeks prior to the first dose of study treatment; 2) Received any previous therapy targeting Claudin18.2; 3) Plan to receive any other anti-tumor therapy during the study; 4) Received strong cytochrome P450 3A4(CYP3A4) inhibitors or inducers within 2 weeks prior to the first dose of study treatment or within 5 half-lives of drug elimination, whichever is longer; 5) Have other malignancies within 5 years prior to signing of ICF; 6) Pregnant or lactating women; 7) Known history of allergy to any component of SKB315 or other monoclonal antibodies (mAbs); 8) Known history of alcohol abuse (consumption of more than 14 units of alcohol per week or drug abuse); 9) Patients with active hepatitis B or hepatitis C; 10) Human immunodeficiency virus (HIV) positive; 11) Active severe digestive disease; 12) History of major cardiovascular diseases 13) Confirmed serious lung disease or lung disease that may impair the respiratory reserve function of the patient as judged by the investigator; 14) History of serious dementia, altered mental status, or any psychiatric disorder; 15) Concomitant or known metastases to brain or central nervous system; 16) Have clinically significant systemic diseases that may adversely affect the safety of the study; 17) Subjects who may have poor compliance with the clinical study or have other factors based on which the investigator considers that the subjects are not appropriate to participate in the study.
- Ib(combination)
- HER2 expression in tumor tissue is positive.
- Has a history of brain metastases.
- Additional malignancy within the five years prior to the first administration.
- Has an active autoimmune disease or a history of autoimmune disease.
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- Received systemic use of corticosteroids or other immunosuppressants for immunosuppressive effects within 14 days prior to the first administration.
- A history of immunodeficiency, including a positive HIV test; Presence of active hepatitis B or hepatitis C.
- In the investigator's judgment, the subjects has other factors that could have affected the study results or led to the forced termination of 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, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Yi Ba, Professor, bayi@tjmuch.com
About this study
Official title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SKB315 for Injection in Patients With Advanced Solid Tumors Expressing Claudin18.2
This is a multicenter, open-label, multiple-dose dose finding and expansion study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and anti-tumor efficacy of SKB315 for injection in patients with advanced solid tumors.
Read the detailed description
This is a multicenter, open-label, multiple-dose dose finding and expansion study to evaluate the safety, tolerability, PK profile, and anti-tumor efficacy of SKB315 for injection in patients with advanced solid tumors.The study is divided into Phase 1a and Phase 1b: Phase 1a is a dose escalation study to determine the maximum tolerated dose(MTD); Phase 1b （monotherapy）is a dose expansion study to conduct preliminary evaluation of anti-tumor efficacy and further evaluation of safety, tolerability, PK, and immunogenicity of SKB315.Phase 1b（combination with Tagitanlimab and Capecitabine） is designed to evaluate the efficacy and safety of SKB315 combination with Tagitanlimab and Capecitabine in CLDN18.2-positive of patients with locally advanced, recurrent, or metastatic gastric and esophagogastric junction adenocarcinoma.
- Conditions
- Advanced Solid Tumors
- Being tested
- SKB315 for injection, Drug: Tagitanlimab Drug: Capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKB315 for injectionDrug
SKB315 for injection is an Antibody Drug Conjugates (ADC) drug targeting Claudin18.2. The strength of SKB315 is 200 mg/vial.
Drug: Tagitanlimab Drug: CapecitabineDrug
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a：Dose escalation | Experimental | Eleven dose levels are tentatively planned for Phase 1a Receives: Drug: SKB315 for injection |
| Phase 1b: Dose expansion | Experimental | The dose of SKB315 for injection in Phase 1b is selected based on the Phase 1a monotherapy dose escalation study. Receives: Drug: SKB315 for injection |
| Phase 1b combination | Experimental | The dose of SKB315 for injection in Phase 1b is selected based on the Phase 1a monotherapy dose escalation study. Receives: Drug: SKB315 for injection; Drug: Drug: Tagitanlimab Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a: Dose Limiting Toxicities (DLT)
Incidence of Dose Limiting Toxicities
Measured: From data of initial dose until up to 21/28 days for treatment
Phase 1b: 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 (3)
Progression Free Survival (PFS)
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
Duration of Response (DOR)
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
Overall Survival (OS)
OS: Time from start of treatment to death due to any reason.
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 posted10 May 2022
- Study start16 Mar 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yi Ba, Professor, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367635
- Sponsor's protocol ID
- SKB315-I-01
- Status last verified
- May 2026
- First submitted
- 21 Apr 2022
- Last updated
- 8 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 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SKB315 for Injection in Patients With Advanced Solid Tumors Expressing Claudin18.2
- ClinicalTrials.gov ID
- NCT05367635
- Acronym / sponsor ID
- SKB315-I-01
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 10 May 2022 (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 is a multicenter, open-label, multiple-dose dose finding and expansion study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and anti-tumor efficacy of SKB315 for injection in patients with advanced solid tumors.
Detailed description
This is a multicenter, open-label, multiple-dose dose finding and expansion study to evaluate the safety, tolerability, PK profile, and anti-tumor efficacy of SKB315 for injection in patients with advanced solid tumors.The study is divided into Phase 1a and Phase 1b: Phase 1a is a dose escalation study to determine the maximum tolerated dose(MTD); Phase 1b （monotherapy）is a dose expansion study to conduct preliminary evaluation of anti-tumor efficacy and further evaluation of safety, tolerability, PK, and immunogenicity of SKB315.Phase 1b（combination with Tagitanlimab and Capecitabine） is designed to evaluate the efficacy and safety of SKB315 combination with Tagitanlimab and Capecitabine in CLDN18.2-positive of patients with locally advanced, recurrent, or metastatic gastric and esophagogastric junction adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1a：Dose escalation | Experimental | Drug: SKB315 for injectionEleven dose levels are tentatively planned for Phase 1a |
| Phase 1b: Dose expansion | Experimental | Drug: SKB315 for injectionThe dose of SKB315 for injection in Phase 1b is selected based on the Phase 1a monotherapy dose escalation study. |
| Phase 1b combination | Experimental | Drug: SKB315 for injection, Drug: Drug: Tagitanlimab Drug: CapecitabineThe dose of SKB315 for injection in Phase 1b is selected based on the Phase 1a monotherapy dose escalation study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ia\&Ib(monotherapy):1) Male or female patients aged 18 to 80 years (inclusive) at the time of signing the informed consent form (ICF); 2) Patients with histologically and/or cytologically confirmed advanced solid tumors who have failed standard of care, or who have no available standard of care regimen, or who are unqualified for standard of care; 3) Consent to provide archival or fresh tumor tissue slides for immunohistochemistry (IHC) assessment, and advanced solid tumors with Claudin 18.2 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) Have recovered to ≤ Grade 1 (according to national cancer institute (NCI) common terminology criteria adverse events (CTCAE) V5.0) from previously treated toxicity prior to the first dose of study treatment; 9) Patients of childbearing potential (male or female) must use effective medical contraception during the study and for 6 months after the end of dosing; 10) Patients voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol-specified visits and relevant procedures.
- Phase Ib (combination) Inclusion criteria
- Age 18 to 80 years old (including boundary values);
- Histopathologically confirmed unresectable locally advanced, recurrent, or metastatic adenocarcinoma of the gastric and gastroesophageal junction 3 positive CLDN18.2 expression in tumor tissue;
- 4. ECOG score 0-1; 5. Expected survival ≥3 months; 6. There is at least one measurable lesion that meets the RECIST 1.1 criteria; 7. Adequate bone marrow and organ function
Key exclusion criteria (9 listed)
- Ia\&Ib(monotherapy)1) Received other drugs in clinical study, major surgeries, or any other anti-tumor therapies within 4 weeks prior to the first dose of study treatment; 2) Received any previous therapy targeting Claudin18.2; 3) Plan to receive any other anti-tumor therapy during the study; 4) Received strong cytochrome P450 3A4(CYP3A4) inhibitors or inducers within 2 weeks prior to the first dose of study treatment or within 5 half-lives of drug elimination, whichever is longer; 5) Have other malignancies within 5 years prior to signing of ICF; 6) Pregnant or lactating women; 7) Known history of allergy to any component of SKB315 or other monoclonal antibodies (mAbs); 8) Known history of alcohol abuse (consumption of more than 14 units of alcohol per week or drug abuse); 9) Patients with active hepatitis B or hepatitis C; 10) Human immunodeficiency virus (HIV) positive; 11) Active severe digestive disease; 12) History of major cardiovascular diseases 13) Confirmed serious lung disease or lung disease that may impair the respiratory reserve function of the patient as judged by the investigator; 14) History of serious dementia, altered mental status, or any psychiatric disorder; 15) Concomitant or known metastases to brain or central nervous system; 16) Have clinically significant systemic diseases that may adversely affect the safety of the study; 17) Subjects who may have poor compliance with the clinical study or have other factors based on which the investigator considers that the subjects are not appropriate to participate in the study.
- Ib(combination)
- HER2 expression in tumor tissue is positive.
- Has a history of brain metastases.
- Additional malignancy within the five years prior to the first administration.
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 |
|---|---|---|
| SKB315 for injectionSKB315 for injection is an Antibody Drug Conjugates (ADC) drug targeting Claudin18.2. The strength of SKB315 is 200 mg/vial. | Drug | Phase 1a：Dose escalation, Phase 1b combination, Phase 1b: Dose expansion |
| Drug: Tagitanlimab Drug: Capecitabine | Drug | Phase 1b combination |
Primary outcome
Phase 1a: Dose Limiting Toxicities (DLT)
Time frame: From data of initial dose until up to 21/28 days for treatment
Incidence of Dose Limiting Toxicities
Phase 1b: 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.
3 secondary outcomes
Progression Free Survival (PFS)
Time frame: Up to 2 years
Duration of Response (DOR)
Time frame: Up to 2 years
Overall Survival (OS)
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 8 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
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SKB315 for injection and Drug: Tagitanlimab Drug: Capecitabine in people with Advanced Solid Tumors, 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 8 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 (022-23340123, bayi@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1a: Dose Limiting Toxicities (DLT) (time frame: From data of initial dose until up to 21/28 days for treatment). The study lists 2 primary outcomes in all. 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 8 May 2026.