Experimental pill takes on Hard-to-Treat ovarian cancer
NCT ID NCT06687070
First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time
Summary
This early-stage trial tests an experimental oral drug called APG-2449, alone or combined with another cancer drug, in people with platinum-resistant recurrent ovarian cancer or other advanced solid tumors. The study aims to find safe doses and understand how the drug works in the body. Participants must have measurable tumors and be in relatively good health.
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 drug called APG-2449, taken orally once daily, sometimes combined with another drug called PLD (pegylated liposomal doxorubicin) given by injection
- What this could lead to
- If successful, this could point toward a new treatment option for people with ovarian cancer that no longer responds to platinum-based chemotherapy.
- What could go wrong
- This is an early Phase 1 trial with only 90 participants, so the drug may prove unsafe or ineffective. Side effects and dose-limiting toxicities are being closely monitored.
Why investors are watching
Ascentage Pharma is testing APG-2449, an experimental drug, in a small Phase 1 trial for patients with platinum-resistant ovarian cancer and other advanced solid tumors. For a small publicly traded company, this early-stage readout matters because it will show whether the drug is safe and shows signs of controlling disease, which could shape the company's future pipeline value.
If it works: If APG-2449 proves safe and shows meaningful disease control in this hard-to-treat group, Ascentage could advance the drug to later-stage trials and attract partnership interest. A positive signal would validate the company's research approach and support its clinical program.
If it fails: Phase 1 trials often fail to show enough benefit or reveal safety problems, and this one is still early with only 90 planned participants. A poor result or delay could set back the drug's development and hurt the company's prospects, since it has few other late-stage assets mentioned.
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
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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May 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. Part A: No gender limitation. Patients with histologically and/or cytologically confirmed ALK/ROS1 gene fusion positive non-small cell lung cancer and various advanced tumors. Part B: Female only. Histologically proven ovarian epithelial, fallopian tube, or primary peritoneal carcinoma. 2. At least one measurable tumor lesion. 3. ECOG score is 0\~1. 4. Life expectancy of ≥3 months. 5. AE caused by previous treatment must recover to ≤ grade 1. 6. Sufficient bone marrow, liver, kidney and coagulation function. 7. Female patients must be in a non-pregnant and non-lactating state. 8. Able to understand and willing to sign informed consent. 9. Patients are required to provide fresh or archived tumor tissue samples prior to treatment. Exclusion Criteria: 1. Undergone major surgery or major trauma within 28 days before first dose or a diagnostic biopsy within 14 days before first dose. 2. Received systemic antitumor drugs, including investigational drugs. 3. Received radiotherapy within 14 days before first dose. 4. Previous treatment with FAK inhibitors. 5. Have tumors at positions other than existing ovarian cancer or of other histological types within 3 years before first dose. 6. Known active central nervous system (CNS) metastases and/or cancerous meningitis. 7. Major cardiovascular and cerebrovascular disease occurred within 6 months before first dose. 8. Patients with pleural effusion, pericardial effusion, or ascites requiring puncture, drainage, or having received drainage within 1 month before first dose. 9. Malabsorption syndrome, or inability to take medications orally. 10. Severe gastrointestinal disease. 11. Any serious or uncontrolled systemic disease; Various chronic active infections. 12. Allergy to APG-2449 or PLD and its drug components. 13. Previous cumulative doses of anthracyclines ≥550 mg/m\^2. 14. Patients using a moderately potent CYP3A4, CYP2C9, or CYP2C19 inhibitor/inducer or P-gp inhibitor within a week before first dose. Patients using CYP3A4 substrates and the drugs of a narrow treatment window within a week before first dose. 15. Other factors that, in the investigator's judgment, should prevent the patient from entering 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
1 site. 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, 510060, China
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- Can a radioactive 'Smart Bomb' target tough tumors?
- Can a new pill shrink advanced solid tumors?
- Can a Tumor-Directed injection shrink Hard-to-Treat cancers?
- Can a new gemcitabine formulation outsmart advanced solid tumors?
- Can a new antibody help the immune system fight Hard-to-Treat tumors?