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New treatment option for Advanced Solid Cancer
Official title APG-2449 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT03917043
What this study is testing
What is APG-2449?
APG-2449 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced solid cancer.
Also referred to as APG-2449 Capsule.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- APG-2449 is a novel, orally active, multi-targeted tyrosine kinase inhibitor, which inhibits FAK, ALK, and ROS1 with nanomolar potencies. In preclinical studies, APG-2449 demonstrated potent antiproliferative activity in various cancer cell lines as a single agent.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Dose exploration stage: non-small cell lung cancer diagnosed by histology and/or cytology and positive for ALK/ROS1 gene fusion (molecular diagnosis...
- ECOG Performance Status ≤ 1.
- Expectation of life ≥ 3 months.
- According to RECIST version 1.1, there is at least 1 measurable lesion.
- Adequate hematologic and bone marrow functions.
You likely can't join if
- Receiving concurrent anti-cancer therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy); or any investigational therapy within 28 days...
- Receiving TKI therapy within 8 days prior to the first dose of study drug.
- Continuance of toxicities due to prior therapy that do not recover (CTCAE V5.0 Grade\> 1).
- Has difficulty in swallowing, absorbing barrier, or other diseases blocking APG-2449' taken.
- Obvious cardiovascular disease history.
- Failure to recover adequately, as judged by the investigator, from prior surgical procedures. Patients who have had major surgery within 28 days from...
See the full eligibility criteria
- 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...
- ECOG Performance Status ≤ 1.
- Expectation of life ≥ 3 months.
- According to RECIST version 1.1, there is at least 1 measurable lesion.
- Adequate hematologic and bone marrow functions.
- Adequate renal and liver function.
- Normal cardiac function.
- Brain metastases with clinically controlled neurologic symptoms.
- Serum pregnancy test results of women of childbearing age were negative within 7 days before taking the first dose of study drug.
- 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...
- Ability to understand and willingness to sign a written informed consent form
- people must be willing and able to complete the research procedures and follow-up inspections.
- people are required to provide fresh (for recurrent people 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...
- people should provide fresh biopsy tumor tissue specimens prior to treatment.
- 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.
- Receiving TKI therapy within 8 days prior to the first dose of study drug.
- Continuance of toxicities due to prior therapy that do not recover (CTCAE V5.0 Grade\> 1).
- Has difficulty in swallowing, absorbing barrier, or other diseases blocking APG-2449' taken.
- Obvious cardiovascular disease history.
- 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...
- Active symptomatic fungal, bacterial and/or viral infection including, but not limited to, active human immunodeficiency virus (HIV) or viral hepatitis (B or C).
- Known allergies to study drug ingredients or their analogs.
- Female people who are pregnant or breastfeeding, or expecting to become pregnant during the study period.
- 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.
- people 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.
- people who used CYP3A4 substrates and narrow treatment window 1 week before the first study drug.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Zhengzhou, Henan, China; Wuhan, Hubei, China; Changsha, Hunan, China and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.