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Advanced Solid TumorsPhase 1NCT06428331

A Study of SKB518 in Patients With Advanced Solid Tumors

A Phase 1 study testing SKB518 for injection in people with Advanced Solid Tumors, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a first-in-human (FIH), phase 1, multicenter, open-label, dose-escalation study of SKB518 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor relapsed/refractory to standard therapies or for which no effective standard… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
SKB518 for injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteChina
Study dates
4 Jul 2024to 30 Jun 2026
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must be at least 18 years of age at the time of signing the informed consent;
  • Histological or cytological diagnosis of solid tumor that is advanced/metastatic solid tumor by pathology report and have progressed on, have been intolerant to, or have been ineligible for standard of care treatments.
  • Subjects able to provide tumor blocks or 8~10 slides [fresh paraffin-embedded tumor tissue or archived paraffin-embedded tumor tissue (maximum time limit is not more than 2 years)] before the first dose of study intervention for biomarkers testing.
  • At least one measurable lesion can be accurately measured per RECIST v1.1 as determined by the local site investigator/radiology assessment. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • Subjects with Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • Life expectancy of at least 3 months as assessed by the investigators.
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  • Subjects with adequate organ and bone marrow function confirmed by laboratory results within 7 days prior to the first dose.
  • Has recovered from all toxicities from previous therapy with the exception of stable, chronic (>3 months) toxicities not considered a safety risk (e.g. alopecia, vitiligo), after consultation with the Sponsor.
  • Subjects of childbearing potential (male or female) must use effective medical contraception during the study until 6 months after the last dose.
  • Subjects must be able to provide documented voluntary informed consent.

Who cannot join

  • Has known active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis are not eligible.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 5 years.
  • Has a history of major cardiovascular, cerebrovascular or thromboembolic diseases.
  • Has serious and/or uncontrolled concomitant diseases.
  • Has known active tuberculosis.
  • Has known human immunodeficiency virus (HIV) infection that is not well controlled.
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  • Has any active viral hepatitis, hepatitis B or hepatitis C.
  • Has had major surgery within 28 days prior to the first dose.
  • Has known allergy or hypersensitivity to SKB518, or the excipients of SKB518.
  • Has a history of interstitial lung disease (ILD) or a history of non-infectious pneumonitis that required steroids.
  • Clinically serious lung injuries caused by lung diseases.
  • History of documented severe dry eye syndrome.
  • Has a history of allogeneic tissue/solid organ transplant.
  • Has known uncontrollable effusion.
  • Subjects who are vaccinated with live vaccine within 30 days before the first dose, or plan to be vaccinated with live vaccine during the study period.
  • Has received strong cytochrome P450 (CYP3A4) inhibitors or inducers, or has received BCRP inhibitors within 2 weeks prior to the first dose.
  • Subjects who received any chemotherapy, radiotherapy, immunotherapy, or biologic therapy treatment within 4 weeks; or who received any small molecular tyrosine kinase inhibitor, antitumor hormonal therapy, system immune-stimulator, or therapy with traditional Chinese medicines approved for antitumor treatment, etc. within 2 weeks before the first dose.
  • Has an active infection requiring systemic therapy.
  • Subjects with the disease that requires systemic corticosteroid therapy (prednisolone or equivalent dose of similar drugs at a dose of >10 mg/d) or other immunosuppressive therapy within 14 days before the first dose.
  • Is currently participating and receiving study therapy in a study of an investigational agent or has participated and received study therapy in a study of an investigational agent or has used an investigational device within 28 days of fist dose.
  • Before the first dose, the subject's condition deteriorates rapidly.
  • Has a known psychiatric or substance abuse disorders.
  • The Investigator considers other situations that will interfere with the evaluation of the study intervention or the safety of the subjects or the interpretation of the results 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.

Xiaoping Jin, PhD contact

86-028-67255165

jinxp@kelun.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, China

    Jian Zhang PI, PHD, +86 180 1731 2991, syner2000@163.com

    Recruiting

Other trials in China

About this study

Official title: A Phase 1, Multicenter, Open-label First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of SKB518 in Subjects With Advanced Solid Tumors

This is a first-in-human (FIH), phase 1, multicenter, open-label, dose-escalation study of SKB518 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor relapsed/refractory to standard therapies or for which no effective standard therapy is available.

Read the detailed description

This is a first-in-human (FIH), phase 1, multicenter, open-label, dose-escalation study of SKB518 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor relapsed/refractory to standard therapies or for which no effective standard therapy is available. Dose escalation and de-escalation decisions are based on the mTPI-2 design and depend on the number of subjects enrolled and the number of DLTs observed at the current dose level.

Being tested
SKB518 for injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SKB518 for injectionDrug

    Also called SKB518

    SKB518 for injection is administered every 3 weeks (q3w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.

Study groups in NCT06428331
Study groupRoleWhat they receive
Dose EscalationExperimentalSeveral dose levels are tentatively planned for Phase 1
Receives: Drug: SKB518 for injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 data of initial dose until up to 21 days for treatment

  2. Maximum Tolerated Dose (MTD)

    Once the dose escalation stopping criteria are met, the MTD estimated by mTPI-2 will be the dose at which the probability of posterior mean of the DLT rate is between 25% and 35%, closest to 30%, and no more than 35%.

    Measured: From data of initial dose until up to 21 days for treatment

Secondary outcomes (4)

  1. 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 24 months

  2. 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 24 months

  3. 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 24 months

  4. Overall Survival (OS)

    Time from start of treatment to death due to any reason.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2024
  2. Study start4 Jul 2024
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

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
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06428331
Sponsor's protocol ID
SKB518-I-01
Status last verified
May 2026
First submitted
20 May 2024
Last updated
8 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SKB518 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 10 inclusion and 23 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 Xiaoping Jin, PhD (86-028-67255165, jinxp@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 data of initial dose until up to 21 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?

On the ClinicalTrials.gov record for NCT06428331.

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.

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