Can a drug duo outsmart resistant tumors?
NCT ID NCT05701306
First seen Aug 21, 2026 · Last updated Aug 21, 2026
Summary
This trial is testing whether two experimental oral drugs, APG-115 and APG-2575, can help people with neuroblastoma or other solid tumors that have returned or not responded to standard treatment. The study will first find the safest dose, then expand to see how well the drugs work, either alone or in combination. Participants must be at least 5 years old for the single-drug part and at least 12 for the combination, and must have no other suitable treatment options.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- APG-115 (an experimental drug) and APG-2575 (another experimental drug), taken orally, alone or in combination.
- What this could lead to
- If successful, this could offer a new treatment option for people with hard-to-treat neuroblastoma and other solid tumors that have not responded to standard therapies.
- What could go wrong
- This is an early-phase trial, so the drugs may not work as hoped or may cause significant side effects. The results are preliminary and need further validation.
Why investors are watching
Ascentage Pharma is testing APG-115 alone or with APG-2575 in children and adults with recurrent or refractory neuroblastoma or solid tumors. For a small company, this early-stage readout on safety and initial efficacy could shape the value of its pipeline. A clear signal in a hard-to-treat cancer would matter more than a mixed result.
If it works: A positive result could show the drug combination shrinks tumors or controls disease in patients who have run out of options. That evidence could support further development and partnerships for Ascentage.
If it fails: Trials in recurrent or refractory cancers often fail to show enough benefit. A weak safety profile or poor efficacy could delay the program and hurt the company's prospects.
AI-written from the trial record. Speculative, and not investment advice.
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 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2023
- Expected to finish
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Dec 2027
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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5 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. Age ≥5 years for APG-115 monotherapy; age ≥12 years for APG-115 + APG-2575 combination. 2. Relapsed or refractory neuroblastoma or solid tumors with no available or suitable standard therapy. 3. Physical state score ≥ 50. 4. Expected survival ≥ 3 months. 5. There are target lesions (neuroblastoma) or measurable lesions (other solid tumors). 6. Have adequate organ function. 7. Fresh or archived tumor tissue samples should be provided prior to treatment. If none of these specimens are available, inclusion may be made after consultation with the sponsor. 8. Fertile women (≥14 years of age or having menarche) must have a negative serum pregnancy test at the time of the screening visit and must not be breastfeeding or planning to become pregnant during the study period. 9. A potentially fertile male subject (who has spermatoses) or female subject (ibid.) must agree to use effective contraception during the trial period and for 3 months after the trial ends (or is prematurely discontinued). 10. Informed consent must be obtained before carrying out any study procedure specified in the test. For child subjects, the consent of the subject and one of the parent/legal guardian must be obtained. 11. The ability to swallow research drugs. Exclusion Criteria: 1. Received biological therapy, chemotherapy, or other investigational drugs within 21 days prior to dosing. 2. Received radiotherapy, minor surgery/minimally-invasive surgery; small-molecule targeted agents, short-half-life chemotherapeutic agents, or traditional Chinese medicines with anti-tumor indications within 14 days prior to study drug administration (or within 5 half-lives, whichever is shorter). 3. Patients who, according to the investigators' judgment, did not recover sufficiently after surgical treatment. Patients who underwent major surgery within 21 days before receiving the study drug for the first time. 4. Adverse events due to previous antitumor therapy (except grade 2 peripheral neurotoxicity and alopecia that the investigators judged to be of no safety risk) have not recovered (severity higher than grade 1 according to CTCAE version 5.0). 5. Patients with active brain tumors or brain metastases. 6. Active gastrointestinal diseases (e.g. Crohn's disease, ulcerative colitis, or short bowel syndrome) or other malabsorption syndromes that may affect drug absorption. 7. A known hemorrhagic predisposition/disease, such as a history of non-chemotherapy-induced thrombocytopenic bleeding within 1 year before first receiving the study drug; Have active immune thrombocytopenic purpura (ITP), active autoimmune hemolytic anemia (AIHA), or a history of platelet transfusion failure (within 1 year before first receiving the study drug); Severe gastrointestinal bleeding occurred within 3 months. 8. Clinically significant cardiovascular disease, cardiomyopathy, myocardial infarction or history within 6 months prior to administration. 9. Symptomatic active fungal, bacterial, and/or viral infections requiring systemic treatment. 10. Unexplained fever \> 38.5℃ within 2 weeks prior to initial administration (subjects with tumor-related fever, as determined by the investigator, could be enrolled). 11. Received MDM2 inhibitors or BCL-2 inhibitors. 12. Any other circumstances or conditions that the investigator considers the patient inappropriate for participation in the study.
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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
3 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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Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, China
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Tianjin Medical University Cancer Institute & Hospital
RECRUITINGTianjin, Tianjin Municipality, 300060, China
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Tongji Hospital, Huazhong University of Science and Technology (HUST)
RECRUITINGWuhan, Hubei, 430030, China
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- New antibody aims to preserve immune checkpoint while fighting cancer
- Engineered immune cells target two markers on Hard-to-Treat tumors