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

Official title

A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APG-2449 Monotherapy or in Combination With Anticancer Agents in Patients With Platinum-resistant Recurrent Ovarian Cancer or Advanced Solid Tumors

Overview

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

Detailed description

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.

Interventions

• Drug APG -2449
  Orally once a day(QD), every 28 days as a cycle.
• Drug PLD
  Injected on the first day of each cycle, every 28 days as a cycle.

Primary outcome measures

• Treatment-related adverse events per NCI-CTCAE version 5.0. [Time frame: Up to 1 year]
• Dose Limiting Toxicity(DLT). [Time frame: Up to 28 days]

Eligibility criteria

Inclusion criteria

• 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.

• At least one measurable tumor lesion.
• ECOG score is 0\~1.
• Life expectancy of ≥3 months.
• AE caused by previous treatment must recover to ≤ grade 1.
• Sufficient bone marrow, liver, kidney and coagulation function.
• Female patients must be in a non-pregnant and non-lactating state.
• Able to understand and willing to sign informed consent.
• Patients are required to provide fresh or archived tumor tissue samples prior to treatment.

Exclusion criteria

• Undergone major surgery or major trauma within 28 days before first dose or a diagnostic biopsy within 14 days before first dose.
• Received systemic antitumor drugs, including investigational drugs.
• Received radiotherapy within 14 days before first dose.
• Previous treatment with FAK inhibitors.
• Have tumors at positions other than existing ovarian cancer or of other histological types within 3 years before first dose.
• Known active central nervous system (CNS) metastases and/or cancerous meningitis.
• Major cardiovascular and cerebrovascular disease occurred within 6 months before first dose.
• Patients with pleural effusion, pericardial effusion, or ascites requiring puncture, drainage, or having received drainage within 1 month before first dose.
• Malabsorption syndrome, or inability to take medications orally.
• Severe gastrointestinal disease.
• Any serious or uncontrolled systemic disease; Various chronic active infections.
• Allergy to APG-2449 or PLD and its drug components.
• Previous cumulative doses of anthracyclines ≥550 mg/m\^2.
• 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.
• Other factors that, in the investigator's judgment, should prevent the patient from entering the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Sun Yat-sen University Cancer Center — Guangzhou

Identifiers

NCT: NCT06687070 · APG2449OC101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗