APG-2449 Monotherapy or in Combination With PLD in Patients With Platinum-resistant Recurrent OC or Advanced ST

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-17

Study Completion Date

2027-05-31

Brief Summary

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An open, multicenter, dose-exploring Phase I trial include Part A and Part B to evaluate the safety, tolerability and efficacy of APG-2449.

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Detailed Description

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Part A: To evaluate the safety of APG-2449 monotherapy in patients with advanced solid tumors.

Part B: To evaluate the safety, tolerability, and efficacy of APG-2449 combined with PLD in the treatment of ovarian cancer.

Conditions

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Platinum-resistant Recurrent Ovarian Cancer Advanced Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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APG -2449 Monotherapy

Part A: Monotherapy for advanced solid tumors.

Group Type EXPERIMENTAL

APG -2449

Intervention Type DRUG

Orally once a day(QD), every 28 days as a cycle.

APG -2449 combined with PLD

Part B: Dose exploration and expansion of APG-2449 combined PLD.

Group Type EXPERIMENTAL

APG -2449

Intervention Type DRUG

Orally once a day(QD), every 28 days as a cycle.

PLD

Intervention Type DRUG

Injected on the first day of each cycle, every 28 days as a cycle.

Interventions

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APG -2449

Orally once a day(QD), every 28 days as a cycle.

Intervention Type DRUG

PLD

Injected on the first day of each cycle, every 28 days as a cycle.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No