Advanced Solid TumorsPhase 1NCT06736327
A Study on the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of SKB500 in Subjects With Advanced Solid Tumors
A Phase 1 study testing SKB500 in people with Advanced Solid Tumors, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study aims to evaluate the safety, tolerability, PK profile, immunogenicity, and antitumor activity of SKB500 in subjects with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- SKB500
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 13 Dec 2024to 31 Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants between 18 and 75 years old.
- Histologically or cytologically confirmed advanced solid tumors for which standard treatment either does not exist or has proven ineffective or intolerable.
- Subjects should ideally provide a tumor tissue sample for biomarker testing during the screening period.
- Has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- ECOG performance status score of 0 or 1.
- Expected survival of at least 12 weeks.
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- Has adequate hematopoietic, renal and hepatic functions.
- Have recovered to grade ≤ 1 of prior anti-cancer treatment toxicities.
- Male and female subjects must agree to use highly effective contraceptive methods throughout the study.
- Subjects must voluntarily enter the study, sign the informed consent form, and be able to comply with the visits and procedures.
Who cannot join
- Subjects with known active CNS metastases, carcinomatous meningitis, leptomeningeal metastases, or spinal cord compression.
- Subjects with other malignancies within 5 years before the first dose.
- Any severe and/or uncontrolled concurrent disease that may interfere with the subject's participation in the study.
- Active hepatitis B, or hepatitis C; active tuberculosis, or human immunodeficiency virus (HIV) test positive, or known acquired immunodeficiency syndrome (AIDS).
- History of allergy to any component of SKB500 or history of severe hypersensitivity reactions to other monoclonal antibodies.
- Subjects with a history of interstitial lung disease, non-infectious pneumonia, or other pulmonary diseases significantly affecting lung function.
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- History of allogeneic organ transplantation or hematopoietic stem cell transplantation.
- Uncontrolled pleural effusion, ascites, or pericardial effusion.
- Have received ADCs with the same target or the same toxins.
- Have received chemotherapy, small molecule targeted therapy, and traditional Chinese medicine preparations within 14 days or 5 half-lives before the first dose; have received any immunotherapy, large molecule anticancer drug treatment, or more than 30% bone marrow radiation or extensive radiotherapy within 28 days before the first dose.
- Have undergone major surgery or severe trauma within 28 days before the first dose.
- Have received other clinical trial medications within 28 days before the first dose.
- Has previously received anti-cancer or live vaccines within 28 days before the first dose
- Have received systemic steroids or other immunosuppressive treatments within 14 days before the first dose.
- Have received potent CYP3A4 inhibitors, inducers, or BCRP inhibitors within 14 days or 5 half-lives before the first dose.
- Pregnant or lactating female.
- Any disease or condition that, in the investigator's opinion, would compromise subject safety or interfere with study assessments.
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
JILIN Cancer Hospital
Jilin City
Ying Cheng, 0431-80596003, jl.cheng@163.com
About this study
Official title: A Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of SKB500 for Injection in Subjects With Advanced Solid Tumors
This study aims to evaluate the safety, tolerability, PK profile, immunogenicity, and antitumor activity of SKB500 in subjects with advanced solid tumors.
Read the detailed description
This study is a multicenter, open-label Phase I clinical trial to evaluate the safety, tolerability, PK profile, immunogenicity, and antitumor activity of SKB500 in subjects with advanced solid tumors. The study includes a dose-escalation phase, a dose-expansion phase, and an indication-expansion phase.
- Conditions
- Advanced Solid Tumors
- Being tested
- SKB500
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKB500Drug
The administration route of SKB500 is intravenous infusion, with a dosing frequency of Q3W.
| Study group | Role | What they receive |
|---|---|---|
| SKB500 | Experimental | Subjects will receive SKB500 once every three weeks (Q3W). Receives: Drug: SKB500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the incidence of adverse events (AEs)
Measured: Up to 3 years
Evaluate the incidence of serious adverse events (SAEs)
Measured: Up to 3 years
Evaluate the incidence of treatment related adverse events (TRAEs)
Measured: Up to 3 years
Evaluate the incidence of dose-limiting toxicities (DLTs)
Measured: Day 1 to Day 21 in Cycle 1 in the dose escalation part
Secondary outcomes (9)
Investigate the antitumor activity of SKB500
Measured: Up to 3 years
To evaluate the Tmax of SKB500
Measured: Up to 3 years
To evaluate the Cmax of SKB500
Measured: Up to 3 years
To evaluate the Cmin of SKB500
Measured: Up to 3 years
To evaluate the AUC of SKB500
Measured: Up to 3 years
To evaluate the t1/2 of SKB500
Measured: Up to 3 years
To evaluate the CL of SKB500
Measured: Up to 3 years
To evaluate the Vz of SKB500
Measured: Up to 3 years
To evaluate the ADA of SKB500
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start13 Dec 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736327
- Sponsor's protocol ID
- SKB500-Ⅰ-01
- Status last verified
- May 2026
- First submitted
- 9 Dec 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 I Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of SKB500 for Injection in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06736327
- Acronym / sponsor ID
- SKB500-Ⅰ-01
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 16 Dec 2024 (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 aims to evaluate the safety, tolerability, PK profile, immunogenicity, and antitumor activity of SKB500 in subjects with advanced solid tumors.
Detailed description
This study is a multicenter, open-label Phase I clinical trial to evaluate the safety, tolerability, PK profile, immunogenicity, and antitumor activity of SKB500 in subjects with advanced solid tumors. The study includes a dose-escalation phase, a dose-expansion phase, and an indication-expansion phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SKB500 | Experimental | Drug: SKB500Subjects will receive SKB500 once every three weeks (Q3W). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female participants between 18 and 75 years old.
- Histologically or cytologically confirmed advanced solid tumors for which standard treatment either does not exist or has proven ineffective or intolerable.
- Subjects should ideally provide a tumor tissue sample for biomarker testing during the screening period.
- Has at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- ECOG performance status score of 0 or 1.
Key exclusion criteria (17 listed)
- Subjects with known active CNS metastases, carcinomatous meningitis, leptomeningeal metastases, or spinal cord compression.
- Subjects with other malignancies within 5 years before the first dose.
- Any severe and/or uncontrolled concurrent disease that may interfere with the subject's participation in the study.
- Active hepatitis B, or hepatitis C; active tuberculosis, or human immunodeficiency virus (HIV) test positive, or known acquired immunodeficiency syndrome (AIDS).
- History of allergy to any component of SKB500 or history of severe hypersensitivity reactions to other monoclonal antibodies.
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 |
|---|---|---|
| SKB500The administration route of SKB500 is intravenous infusion, with a dosing frequency of Q3W. | Drug | SKB500 |
Primary outcome
Evaluate the incidence of adverse events (AEs)
Time frame: Up to 3 years
Evaluate the incidence of serious adverse events (SAEs)
Time frame: Up to 3 years
Evaluate the incidence of treatment related adverse events (TRAEs)
Time frame: Up to 3 years
Evaluate the incidence of dose-limiting toxicities (DLTs)
Time frame: Day 1 to Day 21 in Cycle 1 in the dose escalation part
9 secondary outcomes
Investigate the antitumor activity of SKB500
Time frame: Up to 3 years
To evaluate the Tmax of SKB500
Time frame: Up to 3 years
To evaluate the Cmax of SKB500
Time frame: Up to 3 years
To evaluate the Cmin of SKB500
Time frame: Up to 3 years
To evaluate the AUC of SKB500
Time frame: Up to 3 years
To evaluate the t1/2 of SKB500
Time frame: Up to 3 years
To evaluate the CL of SKB500
Time frame: Up to 3 years
To evaluate the Vz of SKB500
Time frame: Up to 3 years
To evaluate the ADA of SKB500
Time frame: Up to 3 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.
- Individual participant dataSharing planned: Undecided
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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.
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 SKB500 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 10 inclusion and 17 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 Yan Qing (028-67255480, qingyan@kelun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the incidence of adverse events (AEs) (time frame: Up to 3 years). The study lists 4 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.