Advanced Solid TumorsPhase 1/2NCT07545265
SKB565 for Injection in Advanced Solid Tumors
A Phase 1/2 study testing SKB565 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 I/II clinical study to evaluate the safety and efficacy of SKB565 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?
- SKB565
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesChina
- Study dates
- 31 Aug 2026to Aug 2029
- 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.
- 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.
- 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, pericardial, or ascitic effusions that are poorly controlled, symptomatic, or requiring repeated drainage.
- 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 conjunctivitis, severe meibomian gland disease and/or blepharitis, or a history of corneal diseases that hinder/delay corneal healing.
- Presence of esophagotracheal fistula or esophagoaortic fistula, or tumor invasion or compression of surrounding vital organs and blood vessels accompanied by corresponding clinical symptoms.
- Within 3 months prior to the first administration, there have been 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 28 days prior to 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 SKB565 injection or severe hypersensitivity reactions to other monoclonal antibodies.
- Received chemotherapy, immunotherapy, biological therapy, or other large-molecule antitumor drugs within 28 days prior to the first administration. Received small-molecule targeted therapy or approved antitumor Chinese patent medicine preparations within 14 days prior to 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 28 days prior to the first administration.
- Those who have received treatment with other clinical investigational drugs within 28 days prior to the first administration.
- Individuals who have previously received anti-tumor vaccines or have received any active vaccines within 28 days prior to the first administration.
- 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
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510060
Yilong Wu, 020-83827812, syylwu@live.cn
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510289
Herui Yao, 020-81330975, yaohrsysu@163.com
About this study
Official title: A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SKB565 for Injection in Participants With Advanced Solid Tumors
This is a phase I/II clinical study to evaluate the safety and efficacy of SKB565 in participants with advanced solid tumors. The study includes a dose escalation stage, a dose expansion stage, and a indication expansion stage.
- Conditions
- Advanced Solid Tumors
- Being tested
- SKB565
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKB565Drug
IV infusion on Day 1 and Day 15 of each cycle, every 4 weeks (Q4W), 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 |
|---|---|---|
| SKB565 monotherapy | Experimental | SKB565 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle Receives: Drug: SKB565 |
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 28 days and is at least possibly related to the study drug.
Measured: At the end of Cycle 1 of the dose-escalation phase (each cycle is 28 days)
Objective response rate (ORR)
To evaluate the ORR of SKB565 as assessed by the investigator based on RECIST v1.1.
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 posted22 Apr 2026
- Study start31 Aug 2026
- Primary completionMar 2029 (estimated)
- Study completionAug 2029 (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
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545265
- Sponsor's protocol ID
- SKB565-I/II-01
- Status last verified
- Jul 2026
- First submitted
- 16 Apr 2026
- Last updated
- 3 Sep 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 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SKB565 for Injection in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07545265
- Acronym / sponsor ID
- SKB565-I/II-01
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 22 Apr 2026 (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 phase I/II clinical study to evaluate the safety and efficacy of SKB565 in participants with advanced solid tumors. The study includes a dose escalation stage, a dose expansion stage, and a indication expansion stage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SKB565 monotherapy | Experimental | Drug: SKB565SKB565 will be administered as an intravenous (IV) infusion on Day 1 and Day 15 of each 28-day cycle |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- 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.
Key exclusion criteria (26 listed)
- 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, pericardial, or ascitic effusions that are poorly controlled, symptomatic, or requiring repeated drainage.
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 |
|---|---|---|
| SKB565IV infusion on Day 1 and Day 15 of each cycle, every 4 weeks (Q4W), until radiographic disease progression (PD), intolerable toxicity, participant request for discontinuation, lost to follow-up, or death (whichever occurs first). | Drug | SKB565 monotherapy |
Primary outcome
Number of subjects achieving Dose-limiting toxicity (DLT)
Time frame: At the end of Cycle 1 of the dose-escalation phase (each cycle is 28 days)
DLT is defined as an adverse event (AE) that meets protocol-defined DLT criteria during the first 28 days and is at least possibly related to the study drug.
Objective response rate (ORR)
Time frame: Up to approximately 3 years
To evaluate the ORR of SKB565 as assessed by the investigator based on RECIST v1.1.
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 3 Sep 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SKB565 in people with Advanced Solid Tumors, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 2 sites 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 8 inclusion and 26 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 3 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 2 sites 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 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?
Number of subjects achieving Dose-limiting toxicity (DLT) (time frame: At the end of Cycle 1 of the dose-escalation phase (each cycle is 28 days)). 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?
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 3 Sep 2026.