Advanced Solid TumorsPhase 1/2NCT07459998
SKB103 for Injection in Advanced Solid Tumors
A Phase 1/2 study testing SKB103 for injection monotherapy in people with Advanced Solid Tumors, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
This is a phase 1/2 clinical study to evaluate the safety and efficacy of SKB103 in participants with advanced solid tumors. The study includes a dose escalation stage, a dose expansion stage, and a indication expansion stage. 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?
- SKB103 for injection monotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 277 participants
- Where
- 2 sitesChina
- Study dates
- 23 Apr 2026to 31 Dec 2030
- Phase
- Phase 1/2
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.
- Severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or a history of corneal diseases that hinder/delay corneal healing.
- 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.
- Within 3 months prior to the first administration, there have been clinical symptoms of intestinal obstruction, gastrointestinal perforation or fistula, urethral fistula, and abdominal abscess.
- 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.
- 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 allergies to any components of SKB103 injection or severe hypersensitivity reactions to other monoclonal antibodies.
- 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.
- Within 14 days before the first administration or within 5 half lives of known drugs (whichever is longer), she received a strong inhibitor or strong inducer of cytochrome P450 or a breast cancer resistance protein (BCRP) inhibitor.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150001
Qingwei Meng, 86-0451-86298104, mqwei@126.com
- Recruiting
Shanghai East Hospital, Tongj.University
Shanghai, Shanghai Municipality, 200123
Caicun Zhou, 86-021-38804515, aicunzhoudr@163.com
About this study
Official title: A Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SKB103 for Injection in Participants With Advanced Solid Tumors
This is a phase 1/2 clinical study to evaluate the safety and efficacy of SKB103 in participants with advanced solid tumors. The study includes a dose escalation stage, a dose expansion stage, and a indication expansion stage.
Read the detailed description
This is a multi-center, open-label, phase 1/2 clinical study to evaluate the safety, tolerability, pharmacokinetics (PK) characteristics, immunogenicity, and efficacy of SKB103 in participants with advanced solid tumors. The study includes a Phase 1 dose escalation stage, a Phase 1 dose expansion stage, and a Phase 2 indication expansion stage.
- Conditions
- Advanced Solid Tumors
- Being tested
- SKB103 for injection monotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKB103 for injection monotherapyDrug
IV infusion on Day 1 of each cycle, every 3 weeks (Q3W), until radiographic disease progression (PD), intolerable toxicity, participant request for discontinuation, lost to follow-up, or death (whichever occurs first).
| Study group | Role | What they receive |
|---|---|---|
| SKB103 monotherapy | Experimental | Participants will be dosed with SKB103 for injection every 3 weeks(q3w) Receives: Drug: SKB103 for injection monotherapy |
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 the first 21 days and is at least possibly related to the study drug.
Measured: From date of initial dose until up to 21 days for treatment
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 (4)
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
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
Overall Survival (OS)
Time from start of treatment to death due to any reason.
Measured: Up to approximately 3 years
Maximum observed plasma concentration (Cmax) of SKB103-ADC, SKB103-TAB, and free KL610348.
Pharmacokinetic (PK) parameters of SKB103-ADC, SKB103-TAB, and free KL610348.
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start23 Apr 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 277 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459998
- Sponsor's protocol ID
- SKB103-I/II-01
- Status last verified
- May 2026
- First submitted
- 4 Mar 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No