New cancer drug SKB571 enters first human tests
NCT ID NCT06725381
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests a new drug called SKB571 in 138 adults with advanced solid tumors that have spread or cannot be removed by surgery. The main goal is to check safety and find the right dose, while also looking for signs that the drug shrinks tumors. Participants receive SKB571 every three weeks until their disease gets worse or side effects become too severe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SKB571
- What this could lead to
- If it works, this could point toward a new treatment option for people with advanced solid tumors that have not responded to other therapies.
- What could go wrong
- This is a very early, first-in-human trial with only 138 participants, so safety and effectiveness are not yet proven. Many early-stage cancer drugs do not advance to later trials.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 138 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subjects aged 18-75 years at the time of signing the informed consent form 2. Subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumors . 3. Subjects with at least one measurable lesion assessed by the investigator according to RECIST v1.1. 4. Subjects with Eastern Cooperative Oncology Group (ECOG) status score of 0 or 1. 5. Subjects who are assessed by the investigator to have an expected survival of ≥ 3 months. 6. Subjects who have adequate organ function. 7. Subjects who have recovered from all toxicities due to prior therapy . 8. Male and female subjects must agree to use highly effective contraception methods during the study treatment. 9. Subjects who voluntarily sign the informed consent form. Exclusion Criteria: 1. Subjects with known active or untreated central nervous system (CNS) metastases. 2. Subjects with other malignant tumors within 3 years prior to the first dose. 3. Subjects with history of major cardiovascular, cerebrovascular, or thromboembolic disease. 4. Subjects with known active pulmonary tuberculosis. 5. Subjects with human immunodeficiency virus (HIV) infection, or any known active viral hepatitis, or hepatitis B or hepatitis C. 6. Subjects with major surgery within 28 days prior to the first dose. 7. Subjects with known allergy or hypersensitivity to SKB571 or its excipients. 8. Subjects with clinically severe lung injuries due to pulmonary complications. 9. Subjects with a history of allogeneic tissue/solid organ transplant. 10. Uncontrolled pleural effusion, pericardial effusion, or ascites effusion requiring repeated drainage. 11. Subjects who have received live vaccines within 30 days prior to the first dose of study treatment, or who are scheduled to receive live vaccines during the study. 12. Subjects who have received strong cytochrome P450 (CYP3A4) inhibitors or inducers, or BCRP inhibitors within 2 weeks prior to the first dose of study treatment or within 5 half-lives of known drug, whichever is longer. 13. Subjects who have received chemotherapy, immunotherapy, or biological therapy within 4 weeks prior to the first dose of study treatment. 14. Subjects with active infection requiring systemic anti-infective therapy within 14 days prior to the first dose of study treatment. 15. Subjects with any disease requiring systemic treatment with corticosteroids (prednisone at doses \> 10 mg/d or similar drugs with equivalent doses) or other immunosuppressive therapy within 14 days prior to the first dose of study treatment. 16. Subjects have received an investigational agent or has used an investigational device within 28 days prior to initial dose administration of SKB571. 17. Subjects whose condition deteriorates rapidly before the first dose, such as a severe physical impariment or a change in ECOG score no longer meeting the inclusion criteria. 18. Subjects with a known history of psychosis or drug abuse that will preclude the subject from completing the study. 19. Any condition that, in the opinion of the investigator, will interfere with the assessment of study treatment or the safety of the subject or the interpretation of the study results.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
15 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Bei Jing Cancer Hospital
NOT_YET_RECRUITINGBeijing, China
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Chongqing University Cancer Hospital
RECRUITINGChongqing, China
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Guangxi Medical University Cancer Hospital
RECRUITINGNanning, Guangxi, China
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Guangxi Medical University Cancer Hospital
RECRUITINGLinyi, Shandong, China
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Hubei Cancer Hospital
RECRUITINGWuhan, Hubei, China
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Hunan Cancer Hospital
RECRUITINGChangsha, Hunan, China
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Shandong Cancer Hospital
RECRUITINGJinan, Shandong, China
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Shanghai East Hospital
RECRUITINGShanghai, China
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Shanghai Pulmonary Hospital
NOT_YET_RECRUITINGShanghai, China
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Si Chuan Cancer Hospital
RECRUITINGChengdu, Sichuan, China
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Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, China
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The Affliated Hospital of Nanjing University Medical School
RECRUITINGNanjing, Jiangsu, China
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West China Hospital, Sichuan University
RECRUITINGChengdu, Sichuan, China
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Zhejiang Cancer Hospital
RECRUITINGHangzhou, Zhejiang, China
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Zhongshan Hospital
RECRUITINGShanghai, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors