Experimental drug JS015 takes first steps against advanced solid tumors
NCT ID NCT05770310
First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time
Summary
This early-stage trial tests an experimental drug called JS015 in people with advanced solid tumors who have run out of standard treatment options. The main goal is to check the drug's safety, find the best dose, and see how the body processes it. Up to 12 participants will receive JS015 by intravenous infusion, with researchers monitoring side effects and any signs of tumor shrinkage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental drug called JS015
- What this could lead to
- If this trial shows JS015 is safe and tolerable, it could lead to larger studies testing whether it can shrink or slow advanced solid tumors.
- What could go wrong
- This is a very early, small Phase I trial focused on safety, not effectiveness. The drug may not work against tumors or could cause unexpected side effects.
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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12 people
The number who actually took part.
- Started
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Feb 2023
- Finished
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Mar 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Willing to participate in this study and provide written informed consent; 2. Histologically- or cytologically-confirmed advanced solid tumors considered failure to the standard treatment, or with no standard treatment, or not available to standard treatment; 3. At least one measurable lesion according to RECIST 1.1; 4. Life expectancy ≥ 3 months; 5. Eastern Cooperative Oncology Group (ECOG) 0 or 1; 6. Adequate organ function; 7. Treatment related toxicities due to prior anti-cancer therapy including surgery and radiotherapy must be ≤ grade 1; 8. Women of childbearing age must confirm that the serum pregnancy test is negative within 7 days before the first dose; Male and female patients of child bearing potential will to use abstinence or an effective method of contraception throughout the treatment period and for 90 days following the last dose of study drug; Exclusion Criteria: 1. Allergy or contraindication to JS015 and its ingredients; 2. Has a known additional malignancy in the last 5 years. 3. Pregnancy or lactation; 4. History of immunodeficiency, including human immunodeficiency virus(HIV) test positive, or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 5. Brain or meningeal metastases 6. Pleural effusion, peritoneal effusion or pericardial effusion that required treatment (such as puncture, drainage) 7. Severe cardiovascular and cerebrovascular diseases; 8. Previous antineoplastic therapy meets washout requirements. 9. Severe infection (Criteria for the evaluation of common adverse events(CTC AE) 5.0\>2 grade) occurred within 28 days before the first study administration; Active infection or unexplained fever \> 38.5°C ; 10. Has active tuberculosis or hepatitis B (HBV) or hepatitis C (HCV); 11. moderate to severe that seriously affect lung function; 12. Other serious physical or mental diseases or laboratory abnormalities, or alcoholism, drug abuse, etc.,
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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.
Contacts and locations
Locations
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Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, 150081, China
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Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
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Shandong Cancer Hospital
Jinan, Shandong, 250117, China
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Shanghai Oriental Hospital
Shanghai, Shanghai Municipality, 200120, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A multicenter, Dose-Escalation and expansion phase I/IIa clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, immunogenicity, and preliminary efficacy of SGT003 in patients with advanced solid tumors
- Can a radioactive 'Smart Bomb' target tough tumors?
- Can a new pill shrink advanced solid tumors?
- Can a Tumor-Directed injection shrink Hard-to-Treat cancers?
- Can a new gemcitabine formulation outsmart advanced solid tumors?
- Can a new antibody help the immune system fight Hard-to-Treat tumors?