New experimental drug HS-20108 enters human trials for advanced cancers
NCT ID NCT06936735
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial is testing an experimental drug called HS-20108 in 502 people with advanced solid tumors that have spread or cannot be removed. The main goal is to find a safe dose and check for side effects. Researchers will also look for any signs that the drug might shrink tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HS-20108 (an experimental drug given by IV infusion)
- 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 an early Phase 1 trial focused on safety and dosing, not yet on effectiveness. Many experimental drugs fail at this stage, and side effects are unknown.
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 502 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Feb 2029
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 years and older
- 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. Men or women aged more than or equal to (≥) 18 years. 2. Participants with pathologically confirmed advanced solid tumors. 3. At least one measurable lesion in accordance with RECIST 1.1 4. Fresh or archival tumor tissue available for submission. 5. Eastern Cooperative Oncology Group (ECOG) performance status: 0\~1. 6. Estimated life expectancy \>12 weeks. 7. Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose. Likewise, men also consent to use adequate contraceptive method within the same time limit. 8. Females must have evidence of non-childbearing potential. 9. Signed and dated Informed Consent Form. Exclusion Criteria: 1. Treatment with any of the following: Having received cytotoxic chemotherapy agents, investigational drugs, Chinese medicine treatment with anti-tumor indications, or other anti-tumor therapy (including endocrine therapy, molecular targeted therapy, or biotherapy) within 14 days before the first dose of study treatment. Having received macromolecular anti-tumor drug therapy (including immunotherapy, such as monoclonal antibody drugs and bispecific antibody drugs) within 28 days before the first dose of study treatment. Local radiotherapy for palliation within 2 weeks of the first dose of study drug, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose. Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of study drug. 2. Inadequate bone marrow reserve or serious organ dysfunction. 3. Uncontrolled pleural effusion or ascites or pericardial effusion. 4. Known and untreated, or active central nervous system metastases. 5. Active autoimmune diseases or active infectious disease 6. Known to have interstitial pneumonia or immune pneumonia 7. History of severe allergic reaction, serious transfusion reactions or Allergy to any component of HS-20108 8. The subject who is unlikely to comply with study procedures, restrictions, or requirements judged by the investigator. 9. The subject whose safety cannot be ensured or study assessments would be interfered judged by the investigator. 10. Pregnant women, breastfeeding women or woman who has a child-bearing plan during the study. 11. History of neuropathy or mental disorders, including epilepsy and dementia.
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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
1 site. 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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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, Shanghai Municipality, 200032, 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