Experimental drug JS015 takes first steps against advanced solid tumors

NCT ID NCT05770310

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

12 people

The number who actually took part.

Started

Feb 2023

Finished

Mar 2024

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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

  • Affiliated Cancer Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150081, China

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117, China

  • Shanghai Oriental Hospital

    Shanghai, Shanghai Municipality, 200120, China

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