Can a pill that blocks multiple cancer proteins shrink Hard-to-Treat tumors?
NCT ID NCT03917043
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 165 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2019
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Beijing Cancer Hospital
RECRUITINGBeijing, Beijing Municipality, 100142, China
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Fujian Cancer Hospital
NOT_YET_RECRUITINGFuzhou, Fujian, 350014, China
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Fujian Medical University Union Hospital
NOT_YET_RECRUITINGFuzhou, Fujian, 350001, China
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Henan Provincial Oncology Hospital
RECRUITINGZhengzhou, Henan, China
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Hunan Provincial Oncology Hospital
RECRUITINGChangsha, Hunan, China
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Sun-Yat Sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, 510060, China
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The First affiliated hospital, Sun Yat-sen University
RECRUITINGGuangzhou, Guangdong, China
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Union Hospital medical college Huazhong University of Science and Technology
RECRUITINGWuhan, Hubei, China
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Zhejiang Provincial Oncology Hospital
RECRUITINGHangzhou, Zhejiang, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Operationalising multifactorial ovarian cancer risk assessment using the CanRisk tool versus standard practices.
- Can a new drug shrink advanced solid tumors?
- Can ultrasound sharpen the surgical map for ovarian cancer near the liver?
- Can a targeted drug delivery system shrink lung tumors?
- Can a new drug shrink tumors that resist standard care?
- Could the anesthesia used during surgery influence whether esophageal cancer returns?