Advanced Solid TumorsPhase 1NCT06826040
SKB445 for Injection in Solid Tumors
A Phase 1 study testing SKB445 for injection 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 SKB445 for injection in patients 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?
- SKB445 for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2025to 31 Dec 2027
- 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
- At the time of signing the ICF: age between 18 -75 years, male or female.
- subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumors who have failed/are intolerant/ineligible to or do not have standard therapy, and have at least one measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.
- Expected survival ≥ 3 months.
- Subjects with adequate organ and bone marrow function confirmed by laboratory results
- Subjects of childbearing potential (male or female) must use effective medical contraception during the study
- Ability to understand and willingness to sign ICF, and will be able to comply with the protocol-specified visits and relevant procedures.
Who cannot join
- Has received anti-tumor therapy, including chemotherapy, targeted therapy, tumor immunotherapy, and traditional Chinese medicinal products with anti-tumor indications, within 4 weeks prior to the first dose or within 5 half-lives of known drugs (whichever is shorter).
- Has had major surgery within 4 weeks prior to the first dose.
- Has known history of allergy to any component of SKB445 or SKB445.
- Has a known previous or concurrent other malignancies within 3 years prior to first dose.
- Presence of active central nervous system (CNS) metastases.
- Has uncontrolled or severe cardiovascular disease.
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- Has uncontrolled systemic diseases.
- Has human immunodeficiency virus (HIV) infection; has any active viral hepatitis.
- Subjects with a known history of psychiatric illness or drug abuse that would preclude the subject from complying with the study.
- Has prior autologous/allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
- Has any other conditions such as medical history, treatment and laboratory abnormalities that may confound the study results, interfere with the subject's compliance, or impair the subject's interests, as assessed by the investigator or the sponsor.
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
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250117
Jinming Yu, MD, 0531-67626971, sdyujinming@126.com
About this study
Official title: A Phase 1 Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of SKB445 for Injection in Patients With Advanced Solid Tumors
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 SKB445 for injection in patients with advanced solid tumors.
Read the detailed description
This is an open-label, dose-escalation, multicenter study to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor activity of SKB445 monotherapy in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- SKB445 for injection
- Keywords
- Advanced Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKB445 for injectionDrug
SKB445 for injection is administered every 3 weeks (q3w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Phase | Experimental | Subject will be dosed with SKB445 for injection q3w Receives: Drug: SKB445 for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects achieving Dose-limiting toxicity (DLT)
DLT is defined as an adverse event (AE) that meets protocol defined DLT criteria during cycle 1 and is at least possibly related to study drug.
Measured: From date of initial dose until up to 21 days for treatment
Secondary outcomes (4)
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 3 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 3 years
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 3 years
Overall Survival (OS)
Time from start of treatment to death due to any reason.
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 posted13 Feb 2025
- Study start5 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (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
- 126 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826040
- Sponsor's protocol ID
- SKB445-I-01
- Status last verified
- May 2026
- First submitted
- 19 Jan 2025
- 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 Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of SKB445 for Injection in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06826040
- Acronym / sponsor ID
- SKB445-I-01
- Conditions
- Advanced Solid Tumors
- Keywords
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Feb 2025 (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 SKB445 for injection in patients with advanced solid tumors.
Detailed description
This is an open-label, dose-escalation, multicenter study to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor activity of SKB445 monotherapy in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Phase | Experimental | Drug: SKB445 for injectionSubject will be dosed with SKB445 for injection q3w |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At the time of signing the ICF: age between 18 -75 years, male or female.
- subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumors who have failed/are intolerant/ineligible to or do not have standard therapy, and have at least one measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.
- Expected survival ≥ 3 months.
- Subjects with adequate organ and bone marrow function confirmed by laboratory results
Key exclusion criteria (11 listed)
- Has received anti-tumor therapy, including chemotherapy, targeted therapy, tumor immunotherapy, and traditional Chinese medicinal products with anti-tumor indications, within 4 weeks prior to the first dose or within 5 half-lives of known drugs (whichever is shorter).
- Has had major surgery within 4 weeks prior to the first dose.
- Has known history of allergy to any component of SKB445 or SKB445.
- Has a known previous or concurrent other malignancies within 3 years prior to first dose.
- Presence of active central nervous system (CNS) metastases.
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 |
|---|---|---|
| SKB445 for injectionSKB445 for injection is administered every 3 weeks (q3w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first. | Drug | Dose Escalation Phase |
Primary outcome
Number of subjects achieving Dose-limiting toxicity (DLT)
Time frame: From date of initial dose until up to 21 days for treatment
DLT is defined as an adverse event (AE) that meets protocol defined DLT criteria during cycle 1 and is at least possibly related to study drug.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 3 years
Progression Free Survival (PFS)
Time frame: Up to 3 years
Duration of Response (DOR)
Time frame: Up to 3 years
Overall Survival (OS)
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.
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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 SKB445 for injection 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 7 inclusion and 11 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 Xin Li (086-010-58302512, lixin@kelun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects achieving Dose-limiting toxicity (DLT) (time frame: From date of initial dose until up to 21 days for treatment). 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.