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Advanced Solid TumorsPhase 1/2NCT07586943

SKB118 Injection in Advanced Solid Tumors

A Phase 1/2 study testing SKB118 Injection and SKB118+SKB264 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
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Trial summary

This is a multicenter, open-label, Phase I/II clinical study. The study is divided into two parts, the SKB118 monotherapy study and the SKB118 in combination with SKB264 study. 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?
SKB118 Injection and SKB118+SKB264
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
530 participants
Where
1 siteChina
Study dates
1 Jun 2026to Dec 2030
Phase
Phase 1/2
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

  • Participants voluntarily joined this study and signed an informed consent form.
  • The age at the time of signing the informed consent form must be between 18 and 75 years.
  • Participants with histologically or cytologically confirmed advanced solid tumors who have failed standard therapy, have no standard therapy available, or are intolerant to standard therapy.
  • Participants should provide tumor tissue samples for biomarker testing as much as possible.
  • Researchers evaluated based on Response Evaluation Criteria in Solid Tumors(RECIST) Version 1.1 that there is at least one measurable lesion present.
  • Eastern Cooperative Oncology Group (ECOG) score is 0 or 1.
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  • Expected survival period ≥ 12 weeks.
  • Participants have sufficient bone marrow, liver, kidney, and coagulation functions.
  • Male and female participants must agree to use highly effective contraceptive methods during the study period.

Who cannot join

  • Participants known to have meningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, and active central nervous system (CNS) metastasis.
  • Patients with other malignant tumors within 3 years before the first administration.
  • There are serious heart or vascular diseases or high-risk factors present.
  • According to researchers' judgment, it is an uncontrollable systemic disease.
  • There are pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage (>1 time/week).
  • History of interstitial lung disease or non infectious pneumonia.
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  • There are other lung diseases that may interfere with drug-related pulmonary toxicity.
  • There is a risk of developing esophagotracheal fistula or esophageal pleural fistula, or tumor invasion or compression of surrounding important organs and blood vessels accompanied by related clinical symptoms.
  • Screening imaging shows that the tumor encases important blood vessels or exhibits obvious necrosis or cavities, and the investigator determines that study enrollment would pose a risk of bleeding.
  • Previous or concurrent gastrointestinal perforation, surgical and wound healing complications, and bleeding events.
  • The toxicity of previous anti-tumor treatments has not been relieved, defined as the toxicity has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Version 6.0 grade 0 or 1.
  • Have experienced ≥ Grade 3 immune-related adverse events (irAEs) during prior immunotherapy.
  • Serious infection occurred within 4 weeks before the first administration.
  • Active hepatitis B or C, or simultaneous infection with Hepatitis B virus(HBV) and Hepatitis C virus(HCV).
  • Human immunodeficiency virus (HIV) test is positive or there is a history of acquired immunodeficiency syndrome (AIDS); Known active syphilis infection.
  • Known active pulmonary tuberculosis.
  • Known history of allogeneic organ transplantation or hematopoietic stem cell transplantation.
  • History of allergy to the investigational product or any of its components or severe hypersensitivity to other monoclonal antibodies.
  • Having an active autoimmune disease that required systemic treatment within the past two years.
  • Active or prior history of confirmed inflammatory bowel disease.
  • Currently using or having recently used aspirin therapy.
  • Received oral or parenteral anticoagulants or thrombolytic agents within 2 weeks prior to the first dose.
  • Previous treatment with antibodies or drugs targeting T-cell co- stimulation or checkpoint pathways, as well as cell therapy.
  • Received chemotherapy, immunotherapy, biological therapy, or other large molecule anti-tumor drugs within 4 weeks before the first administration.
  • Within 6 months prior to the first administration, lung lesions received radiation therapy with a total dose greater than 30 Gray.
  • Have undergone major surgical procedures or suffered serious injuries within 4 weeks prior to the first administration of medication.
  • Those who have received treatment with other clinical investigational drugs within 4 weeks prior to their first administration.
  • Individuals who have previously received anti-tumor vaccines or have received any active vaccines within 4 weeks prior to their first treatment with the investigational drug.
  • Participants who received systemic corticosteroid therapy or other immunosuppressive drugs with>10 mg/day prednisone within 2 weeks prior to the first dose.
  • Pregnant or lactating women.
  • Participants with a known history of mental illness or substance abuse are unable to cooperate in completing the study.
  • Suffering from local or systemic diseases caused by non malignant tumors, or diseases or symptoms secondary to tumors, which may affect compliance.
  • Any condition that the researcher deems to interfere with the evaluation of the investigational drug, the safety of participants, or the interpretation of research results, or any other condition that the researcher deems unsuitable for participation in this study.
  • Exclusion Criteria for Part 2 34) Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or a history of corneal disorder that hinders/delays corneal healing.
  • 35) Prior treatment with TROP2-targeted therapy, and any drug therapy containing a topoisomerase I target.
  • 36) Participants who require systemic use of strong inhibitors or inducers of CYP3A4 within 2 weeks before the first dose and during 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.

Yina Diao contact

86-028-67252634

diaoyina@kelun.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200123

    Zhimin Shao, 86-021-64175590, szm@163.com

    Recruiting

Other trials in China

About this study

Official title: A Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SKB118 Injection in Participants With Advanced Solid Tumors

This is a multicenter, open-label, Phase I/II clinical study. The study is divided into two parts, the SKB118 monotherapy study and the SKB118 in combination with SKB264 study.

Read the detailed description

Part 1: SKB118 Monotherapy Study To evaluate the safety, tolerability, PK characteristics, immunogenicity, and efficacy of SKB118 in participants with advanced solid tumors. The study includes a Phase I dose escalation stage, a Phase I dose expansion stage, and a Phase II indication expansion stage.

Part 2: SKB118 in Combination with SKB264 Study To evaluate the safety, tolerability, PK characteristics, immunogenicity, and efficacy of SKB118 in combination with SKB264 in participants with advanced solid tumors. This part includes a Phase I combination therapy dose escalation stage, a Phase I combination therapy dose expansion stage, and a Phase II combination therapy indication expansion stage.

Being tested
SKB118 Injection, SKB118+SKB264

What participants receive

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

  • SKB118 InjectionDrug

    SKB118 Injection monotherapy, iv drip, every 3 weeks (Q3W), until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.

  • SKB118+SKB264Drug

    Administered by intravenous infusion on Day 1 and Day 15 of each 28-day cycle.

Study groups in NCT07586943
Study groupRoleWhat they receive
SKB118 Injection monotherapyExperimentalSubject will be dosed with SKB118 monotherapy every 3 weeks(q3w)
Receives: Drug: SKB118 Injection
SKB118 in combination with SKB264ExperimentalSubject will be dosed with SKB118 combined with SKB264 every 2 weeks(q2w)
Receives: Drug: SKB118+SKB264

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 DLT observation period (within 21 days after the first dose for q3w dosing frequency; within 28 days after the first dose for q2w dosing frequency) and is at least possibly related to the study drug.

    Measured: From date of initial dose until up to 21 days after the first dose for q3w dosing frequency; or up to 28 days after the first dose for q2w dosing frequency

  2. 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 approximately 3 years

Secondary outcomes (5)

  1. 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 3 years

  2. 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 3 years

  3. Overall Survival (OS)

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

    Measured: Up to approximately 3 years

  4. Maximum observed plasma concentration (Cmax) of SKB118

    Pharmacokinetic (PK) parameters of SKB118

    Measured: Up to approximately 2 years

  5. Maximum observed plasma concentration (Cmax)of SKB264-ADC,SKB264-TAB and free KL610023

    Pharmacokinetic (PK) parameters of SKB264

    Measured: Up to approximately 2 years

Timeline

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

  1. First posted14 May 2026
  2. Study start1 Jun 2026
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2030 (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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
530 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07586943
Sponsor's protocol ID
SKB118-I/II-01
Status last verified
Aug 2026
First submitted
7 May 2026
Last updated
11 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SKB118 Injection and SKB118+SKB264 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 9 inclusion and 36 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 11 Sep 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 combined 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.

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?

Contact Yina Diao (86-028-67252634, diaoyina@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 after the first dose for q3w dosing frequency; or up to 28 days after the first dose for q2w dosing frequency). 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 NCT07586943.

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 11 Sep 2026.

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