Pancreatic CancerPhase 2NCT07814066
A Multicenter, Open-label, Phase II Umbrella Study to Evaluate the Efficacy and Safety of the Investigational Product in Participants With Advanced or Metastatic Pancreatic Cancer
A Phase 2 study testing SKB571 in people with Pancreatic Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd..
Trial summary
This is a multicenter, open-label, Phase II umbrella study conducted in participants with advanced or metastatic pancreatic cancer. This study has set up different cohorts to evaluate the efficacy and safety of multiple investigational products in pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- SKB571
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2026to 31 May 2028
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 75 years at the time of signing the informed consent form.
- Histologically or cytologically confirmed advanced or metastatic pancreatic cancer.
- Subjects with at least one measurable lesion assessed by the investigator according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 7 days before the first dose.
- Participants who have adequate bone marrow, liver, kidney, and coagulation function.
- Male and female participants must agree to use highly effective methods of contraception during the specified period of the study.
- Participants must voluntarily join this study, sign the informed consent form (ICF), and be able to comply with the visits and related procedures specified in the protocol.
Who cannot join
- History or current metastases to central nervous system.
- Histologically or cytologically confirmed other pathological types or differentiation combined with other pathological types.
- Subjects with other malignant tumors within 3 years prior to the first dose.
- Presence of any cardiovascular and cerebrovascular disorders or risk factors.
- Presence of uncontrolled systemic disease.
- Presence of clinically symptomatic or uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
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- History of interstitial lung disease (ILD) or non-infectious pneumonitis.
- Presence within 3 months before the first dose of other moderate to severe lung disorders.
- Tumor invasion or compression of surrounding vital organs and major blood vessels.
- Active severe digestive system diseases.
- Unresolved toxicity from prior anti-tumor therapy.
- Serious infection within 4 weeks before the first dose.
- Presence of active HIV, hepatitis B or hepatitis C or co-infection with HBV and HCV.
- Known history of allogeneic organ transplant or hematopoietic stem cell transplant.
- History of allergy to any component of the study drug or severe hypersensitivity to other monoclonal antibodies.
- Participants who have undergone major surgery or had severe trauma within 4 weeks before the first dose, or are expected to require major surgery during the study.
- Participants who have received other investigational drug treatments within 4 weeks before the first dose.
- Pregnant or breastfeeding women.
- Known history of psychosis or drug abuse that prevents the participant from cooperating with the study.
- Have local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which may lead to higher medical risk and/or uncertainty in survival assessment, or may affect protocol compliance.
- Any condition that, in the investigator's opinion, interferes with the evaluation of the investigational product, participant safety, or interpretation of study results, or any other condition that the investigator deems unsuitable for participation in this study.
About this study
This is a multicenter, open-label, Phase II umbrella study conducted in participants with advanced or metastatic pancreatic cancer. This study has set up different cohorts to evaluate the efficacy and safety of multiple investigational products in pancreatic cancer.
- Conditions
- Pancreatic Cancer
- Being tested
- SKB571
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKB571Drug
q3w
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: SKB571 monotherapy | Experimental | Not described Receives: Drug: SKB571 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
ORR as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: Up to approximately 24 months.
Secondary outcomes (8)
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 approximately 24 months.
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 approximately 24 months.
Disease control rate (DCR)
Assessed by the investigators as per RECIST v1.1
Measured: Up to approximately 24 months.
Overall Survival (OS)
Time from start of treatment to death due to any reason.
Measured: Up to approximately 24 months.
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (based on CTCAE v6.0), clinically significant abnormal laboratory test results.
Measured: Up to approximately 24 months.
Maximum Plasma Concentration (Cmax) of the investigational product
Blood Samples will be collected to determine the Cmax of the investigational product in the plasma.
Measured: Up to approximately 24 months.
Minimum Plasma Concentration (Cmin) of the investigational product
Blood Samples will be collected to determine the Cmin of the investigational product in the plasma.
Measured: Up to approximately 24 months.
Immunogenicity of the investigational product
Incidence of anti-drug antibody (ADA) against the investigational product.
Measured: Up to approximately 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start31 Oct 2026 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814066
- Sponsor's protocol ID
- SKB-PDAC-01
- Status last verified
- Aug 2026
- First submitted
- 2 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Phase II Umbrella Study to Evaluate the Efficacy and Safety of the Investigational Product in Participants With Advanced or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07814066
- Acronym / sponsor ID
- SKB-PDAC-01
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 10 Sep 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 is a multicenter, open-label, Phase II umbrella study conducted in participants with advanced or metastatic pancreatic cancer. This study has set up different cohorts to evaluate the efficacy and safety of multiple investigational products in pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort A: SKB571 monotherapy | Experimental | Drug: SKB571 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 and ≤ 75 years at the time of signing the informed consent form.
- Histologically or cytologically confirmed advanced or metastatic pancreatic cancer.
- Subjects with at least one measurable lesion assessed by the investigator according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 7 days before the first dose.
- Participants who have adequate bone marrow, liver, kidney, and coagulation function.
Key exclusion criteria (21 listed)
- History or current metastases to central nervous system.
- Histologically or cytologically confirmed other pathological types or differentiation combined with other pathological types.
- Subjects with other malignant tumors within 3 years prior to the first dose.
- Presence of any cardiovascular and cerebrovascular disorders or risk factors.
- Presence of uncontrolled systemic disease.
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 |
|---|---|---|
| SKB571q3w | Drug | Cohort A: SKB571 monotherapy |
Primary outcome
Objective response rate (ORR)
Time frame: Up to approximately 24 months.
ORR as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
8 secondary outcomes
Progression-free survival (PFS)
Time frame: Up to approximately 24 months.
Duration of Response (DOR)
Time frame: Up to approximately 24 months.
Disease control rate (DCR)
Time frame: Up to approximately 24 months.
Overall Survival (OS)
Time frame: Up to approximately 24 months.
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to approximately 24 months.
Maximum Plasma Concentration (Cmax) of the investigational product
Time frame: Up to approximately 24 months.
Minimum Plasma Concentration (Cmin) of the investigational product
Time frame: Up to approximately 24 months.
Immunogenicity of the investigational product
Time frame: Up to approximately 24 months.
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 10 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SKB571 in people with Pancreatic Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd..
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 7 inclusion and 21 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 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Up to approximately 24 months.). 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 10 Sep 2026.