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New pill aims to control advanced tumors in early human test

NCT ID NCT06943677

Disease control Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times

Summary

This early-stage study tests an experimental oral drug called TQB3019 in 80 adults with advanced malignant tumors that have come back or not responded to treatment. The main goals are to check safety, find the right dose, and get a first look at whether the drug can shrink tumors. Participants take the capsule by mouth, and the study is not yet complete.

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 80 people

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

Started

May 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 years and older

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: * Subjects voluntarily joined the study, signed informed consent form, and with good compliance. * ≥18 years old; Eastern Cooperative Oncology Group (ECOG) physical status: 0-2; at least 3 months expected survival period. * Clearly diagnosed recurrent / refractory hematological tumors that meet the World Health Organization (WHO) definition; * At least 1 measurable lesion for efficacy evaluation. * The function of main organs is normal. * Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; a negative serum pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped. Exclusion Criteria: * Patients has had or is currently having other malignant tumors within 3 years. The following two conditions can be included in the group: other malignant tumors treated with a single operation to achieved 5 consecutive years of disease free survival (DFS)s. Cured cervical carcinoma in situ, non-melanoma skin cancer, nasopharyngeal carcinoma and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\]. * Subjects with central nervous system aggression (CNS); * Received allogeneic hematopoietic stem cell transplantation (allo-HSCT) or had active graft-versus-host disease (GVHD) requiring immunosuppressive therapy within 12 months before the first dose; * Multiple factors that affect the absorption of oral medications (e.g., inability to swallow, chronic diarrhea, and intestinal obstruction); * Unrelieved toxicity of ≥CTC AE grade 1 due to any previous treatment, excluding alopecia and fatigue; * Major surgical treatment, open biopsy, and significant traumatic injury were received within 28 days before the start of study treatment. * The presence of active or uncontrolled primary autoimmune cytopenia, including autoimmune hemolytic anemia (AIHA) and primary immune thrombocytopenia (ITP); * Patients with evidence or history of bleeding constitution; Or any bleeding event (such as gastrointestinal bleeding) greater than or equal to CTC AE level 3 within 4 weeks before the first medication; * Subjects had an arteriovenous thrombosis event within 6 months. * Subjects have history of psychotropic substance abuse and are unable to abstain or have mental disorders; * Subjects with any severe and/or uncontrolled disease. * Within 2 weeks before the first treatment, the subjects had received proprietary Chinese medicines with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions; * Previously received treatment with drugs similar to TQB3019 capsules; * Uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage (investigator judgment) * Study treatment related: subjects received live or messenger RNA (mRNA) vaccines within 4 weeks before the first treatment or were scheduled to receive live or mRNA vaccines during the study; * Participated in clinical trials of other antitumor drugs within 4 weeks before the first treatment; * According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are considered unsuitable for enrollment for other reasons.

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Conditions

The condition(s) this trial relates to.

cancer refractory hematologic cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced malignant cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites. 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

  • Affiliated Hospital of North sichuan Medical college

    RECRUITING

    Nanchong, Sichuan, 637000, China

  • Cancer Institute & Hospital.Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, 100021, China

  • Heze Municipal Hospital

    RECRUITING

    Heze, Shandong, 27400, China

  • Institute of Hematology ＆Blood Diseases Hospital,Chinese Academy of Medical Sciences ＆Peking Union Medical College

    RECRUITING

    Tianjin, Tianjin Municipality, 301617, China

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • Mianyang Central Hospital

    RECRUITING

    Mianyang, Sichuan, 621000, China

  • Nanfang Hospital of Southern Medical University

    RECRUITING

    Guangzhou, Guangdong, 510515, China

  • The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450000, China

  • The Affiliated Hospital of Qingdao University

    RECRUITING

    Qingdao, Shandong, 266075, China

  • The Affiliated Hospital of Southwest Medical University

    RECRUITING

    Luzhou, Sichuan, 646099, China

  • The Cancer Hospital Affiliated to Shandong First Medical University

    RECRUITING

    Jinan, Shandong, 250117, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi'an, Shaanxi, 710061, China

  • TianJin Medical University Cancer Institute&Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300000, China

  • Tongji Hospital of Tongji University

    RECRUITING

    Shanghai, Shanghai Municipality, 200065, China

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