Experimental pill takes on Hard-to-Treat ovarian cancer

NCT ID NCT06687070

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 90 people

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

Started

Dec 2024

Expected to finish

May 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. 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.

  1. The places running it

    1 site. 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.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

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