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Can a new biologic boost standard brain cancer therapy?

NCT ID NCT06147505

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This trial is testing whether adding an experimental drug called XS005 to the standard chemotherapy regimen (Stupp) is safe and shows promise for people with glioblastoma, an aggressive brain tumor. The study involves 13 adults aged 18 to 70 who will receive XS005 infusions over 16 weeks alongside their usual treatment. The main goals are to find the highest safe dose and to see if the combination may help slow tumor growth.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
XS005 injection (an experimental biologic) combined with the standard Stupp chemotherapy regimen
What this could lead to
If successful, this could lead to a new treatment option that improves outcomes for people with glioblastoma, a type of brain cancer.
What could go wrong
This is an early-phase trial with only 13 participants, so results may not apply broadly. The main focus is safety, and the treatment may cause side effects or not effectively control the tumor.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 13 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Aug 2026

An estimate. End dates often move.

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 70 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. Age between 18 and 70 years old (including the threshold), both male and female; 2. Expected survival ≥6 months; 3. Karnofsky performance status(KPS) score ≥60 before treatment; 4. The level of organ and bone marrow function must meet the following requirements: * Bone marrow: Absolute neutrophil count (ANC) ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥90g/L, and no platelet or red blood cell transfusion within 14 days prior to first administration. And did not receive blood transfusion or biological response regulators (such as granulocyte growth factor, erythrocyte growth factor, interleukin-11, etc.) within 14 days before the first administration; * Liver function: No history of cirrhosis (Child-Pugh grade B, C). Serum total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; * Renal function: serum creatinine ≤1.5×ULN, or creatinine clearance ≥50ml/min (Cockcroft-Gault formula); Qualitative urine protein ≤1+; If the qualitative urine protein is ≥2+, it is necessary to conduct a quantitative urine protein test for 24 hours. According to the examination results, the researchers made the admission judgment. * Coagulation function: prothrombin time (PT) ≤1.5×ULN; International standardized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5×ULN (except those receiving therapeutic anticoagulants); 5. The subjects (including male subjects) have no pregnancy plan and voluntarily take effective contraceptive measures during the screening period and from the beginning of the study administration to the last dose of the study drug within 6 months after the study drug is administered, and have no sperm or egg donation plans, in which the study period should voluntarily take effective contraceptive measures; 6. Able to understand the procedures and methods of this study, willing to sign informed consent and strictly follow the clinical study protocol to complete this study. Exclusion Criteria: 1. Patients who received other anti-tumor drugs (including chemotherapy, targeted drugs other than bevacizumab, immunotherapy, Chinese medicine anti-tumor therapy, etc.) except for patients who received concurrent radiotherapy and chemotherapy for GBM after surgery (TMZ dosage ≤75mg/m2, radiotherapy dose limited to 50-60Gy); 2. Previous or current malignant tumors of other types, except for the following cases: basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin or cervical cancer in situ; 3. The presence of any contraindications to MRI, such as: use of a pacemaker, infusion pump, or allergy to MRI contrast agents; 4. Receive live attenuated vaccine or vaccine within 4 weeks prior to the first study drug treatment or plan to receive live vaccine during the study period; 5. Subjects with active or pre-existing autoimmune diseases that are likely to recur, or patients at high risk (such as those who have received an organ transplant and require immunosuppressive therapy).

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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

  • Dushu Lake Hospital Affiliated to Soochow University

    Suzhou, Jiangsu, 215125, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.