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New hope for advanced cancer? early trial of SIBP-A19 begins

NCT ID NCT06990464

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial is testing a new drug, SIBP-A19, in 156 people with advanced solid tumors who have no other standard treatment options. The main goals are to check the drug's safety, find the best dose, and look for early signs that it might shrink tumors. The drug is given by IV every 21 days.

What this could mean

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

Active substance
SIBP-A19
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors who have run out of standard therapies.
What could go wrong
This is a very early Phase 1 trial with only 156 participants, so the drug may not prove safe or effective. Side effects are unknown, and many early-stage cancer drugs never reach approval.

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

About 156 people

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

Started

Jun 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

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: * Age range from 18 to 75 years old (including boundary values), regardless of gender. * Voluntarily participate in this study and sign the informed consent form. * Participants with advanced or metastatic solid tumors diagnosed by histology or cytology, without standard treatment, standard treatment failure, or intolerance. * Willing and able to provide sufficient fresh collected or archived tumor tissue samples or provide testing reports from legitimate institutions that meet the requirements. * There must be at least one measurable lesion as the target lesion. * ECOG score 0-1. * Expected survival time ≥ 3 months. * During the screening period, the main organ functions were basically normal (no medical support such as blood transfusion, granulocyte colony-stimulating factor (G-CSF), or other medical support was received within 14 days before the use of the investigational drug): • Blood routine: Absolute value of neutrophils (NE #) ≥ 1.5 × 10 9/L, platelet (PLT) count ≥ 90 × 10 9/L, hemoglobin (HGB) ≥ 90 g/L. * Women of childbearing age during the screening period who have a negative blood pregnancy test and are capable of reproduction (including male participants) have no pregnancy plan and voluntarily take effective contraceptive measures during the trial period and within 6 months after the last dose. Exclusion Criteria: * Participants with the following tumors: * The participant has had other malignant tumors that have not been cured within the past 5 years (excluding malignant tumors that have been clearly cured, such as thyroid cancer, cured basal cell carcinoma of the skin, and cervical carcinoma in situ). * The participant has untreated imaging confirmed central nervous system metastasis. * Meningeal metastases. * Patients with brain metastases who have received systematic or curative brain metastasis treatment (radiotherapy or surgery) in the past, have been confirmed stable by imaging for at least 4 weeks, and have stopped systemic hormone, antiepileptic, convulsive drugs, and other treatments for more than 2 weeks without clinical symptoms can be enrolled. * Participants with a history of previous treatment or surgery, or those who received the following anti-tumor treatments during the planned trial period: * Patients who accepted the instructions clearly containing traditional Chinese patent medicines and simple preparations with anti-tumor effect within 2 weeks before the first administration; * Patients undergoing adjuvant therapy within 6 months after surgery; * Patients who have not recovered from the toxicity of the previous anti-tumor treatment to normal or ≤ level 1 (excluding hair loss); * Patients who have undergone major surgery, radiation therapy, biological therapy, or chemotherapy within 4 weeks prior to their first administration, or who have received systemic treatment such as unhealed surgical wounds, ulcers or fractures, or other clinical trial drugs. * Patients who plan to receive any other anti-tumor treatment (chemotherapy, radiation therapy, immunotherapy, cytokine therapy other than erythropoietin) during the trial period should be excluded (excluding testosterone lowering therapy for prostate cancer patients). * The dose (prednisone\>10 mg/d or equivalent) at which immunosuppressive effects are achieved by receiving immunosuppressive agents or systemic corticosteroids within one week prior to the use of the investigational drug. * Participants with a history of previous illnesses or laboratory tests that show the following abnormalities: * Individuals with abnormal coagulation function and a tendency to bleed, or who are undergoing thrombolysis or anticoagulation treatment or have lost blood or donated more than 400 mL within 2 months prior to administration. * Have a history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation. * Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia. * Known history of drug abuse, alcoholism, or drug use that may affect the results of the trial. * According to the investigator's judgment, the screening period is accompanied by serious, progressive, or uncontrolled diseases, and the investigator's assessment determines that the participant's participation in the study will increase the risk. * According to the investigator's judgment, there are serious accompanying diseases that pose a threat to patient safety or affect the completion of the study. * Patients with uncontrolled ascites, pleural effusion, pericardial effusion during the screening period or those who require drainage, or those who have undergone serosal fluid drainage within 4 weeks before the first administration. * Patients who must take supplements containing folic acid (such as those with folate deficiency). * Individuals with a history of severe allergies to protein products, CHO cell products, other recombinant human or humanized antibodies, or components of the investigational drug. * Pregnant and lactating women. * Patients who are deemed unsuitable to participate in this clinical study due to other reasons by the investigators.

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • The Union Hospital affiliated to Fujian Medical University

    RECRUITING

    Fuzhou, Fujian, China

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