Can a pill that blocks multiple cancer proteins shrink Hard-to-Treat tumors?

NCT ID NCT03917043

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This early-phase trial is testing an experimental oral drug called APG-2449 in people with advanced solid tumors, including certain lung cancers, mesothelioma, esophageal cancer, and ovarian cancer. APG-2449 is designed to block several proteins (FAK, ALK, and ROS1) that help cancer cells grow. The study aims to find the safest dose and understand how the drug moves through the body.

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 oral drug called APG-2449, a multi-targeted tyrosine kinase inhibitor that blocks FAK, ALK, and ROS1 proteins
What this could lead to
If it works, this could point toward a new treatment option for certain advanced solid tumors, especially lung cancers with specific gene changes.
What could go wrong
This is an early phase 1 trial, so the drug may not work as hoped or could cause unexpected side effects. The safe dose and effectiveness are still unknown.

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 165 people

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

Started

May 2019

Expected to finish

Jan 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: 1. Dose exploration stage: non-small cell lung cancer diagnosed by histology and/or cytology and positive for ALK/ROS1 gene fusion (molecular diagnosis confirmed by the investigator) and malignant pleural mesothelioma, esophageal cancer and ovarian cancer. Kind of patients with advanced tumors. Expansion stage: cohort 1, patients with non-small cell lung cancer who have progressed or are intolerant to TKI therapy, including patients with second-generation ALK TKI, or either ROS1 TKI, or third-generation ALK inhibitor (lorlatinib, etc.) with pFAK expression (pFAK expression is subject to central laboratory results) of about 10 or above; Cohort 2, TKI-naïve patients with ALK/ROS1 fusion gene positive NSCLC. The molecular diagnosis results of the above patients can be confirmed by the investigator. 2. ECOG Performance Status ≤ 1. 3. Expectation of life ≥ 3 months. 4. According to RECIST version 1.1, there is at least 1 measurable lesion. 5. Adequate hematologic and bone marrow functions. 6. Adequate renal and liver function. 7. Normal cardiac function. 8. Brain metastases with clinically controlled neurologic symptoms. 9. Serum pregnancy test results of women of childbearing age were negative within 7 days before taking the first dose of study drug. 10. Men, women of childbearing age (postmenopausal women must have been menopausal for at least 12 months before they can be considered infertile) and their partners voluntarily take the study drug for at least 30 days after signing the informed consent form and taking the study drug as deemed effective by the investigator Contraceptive measures 11. Ability to understand and willingness to sign a written informed consent form 12. Subjects must be willing and able to complete the research procedures and follow-up inspections. 13. Subjects are required to provide fresh (for recurrent subjects only) or archived tumor tissue samples from within 28 days prior to treatment. If none of these specimens are available, they may be included after consultation with the sponsor. 14. Subjects should provide fresh biopsy tumor tissue specimens prior to treatment. Exclusion Criteria: 1. Receiving concurrent anti-cancer therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy); or any investigational therapy within 28 days prior to the first dose of study drug. 2. Receiving TKI therapy within 8 days prior to the first dose of study drug. 3. Continuance of toxicities due to prior therapy that do not recover (CTCAE V5.0 Grade\> 1). 4. Has difficulty in swallowing, absorbing barrier, or other diseases blocking APG-2449' taken. 5. Obvious cardiovascular disease history. 6. Failure to recover adequately, as judged by the investigator, from prior surgical procedures. Patients who have had major surgery within 28 days from study entry, and patients who have had minor surgery within 14 days of study entry. 7. Active symptomatic fungal, bacterial and/or viral infection including, but not limited to, active human immunodeficiency virus (HIV) or viral hepatitis (B or C). 8. Known allergies to study drug ingredients or their analogs. 9. Female subjects who are pregnant or breastfeeding, or expecting to become pregnant during the study period. 10. According to the judgment of the investigator or sponsor, any symptoms or disease of the subject may endanger its safety or interfere with the safety assessment of the study drug. 11. Subjects who have used CYP3A4, CYP2C9, or CYP2C19 moderately potent inhibitors or moderately potent inducers 1 week before receiving the study drug for the first time. 12. Subjects who used CYP3A4 substrates and narrow treatment window 1 week before the first study drug.

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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

    9 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

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Fujian Cancer Hospital

    NOT_YET_RECRUITING

    Fuzhou, Fujian, 350014, China

  • Fujian Medical University Union Hospital

    NOT_YET_RECRUITING

    Fuzhou, Fujian, 350001, China

  • Henan Provincial Oncology Hospital

    RECRUITING

    Zhengzhou, Henan, China

  • Hunan Provincial Oncology Hospital

    RECRUITING

    Changsha, Hunan, China

  • Sun-Yat Sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

  • The First affiliated hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, China

  • Union Hospital medical college Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, China

  • Zhejiang Provincial Oncology Hospital

    RECRUITING

    Hangzhou, Zhejiang, China

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