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Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas | Clinical Trials | Clareo Health

UNKNOWNPHASE1

Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas

A Phase I Study of Safety, Pharmacokinetic and Efficacy of Orally Administered APG-5918 in Patients With Advanced Solid Tumors or Hematologic Malignancies

NCT05415098•Ascentage Pharma Group Inc.

View on ClinicalTrials.gov

Summary

This is a multicenter, open-label, Phase 1 study that will be conducted in two parts. Part 1 is the dose escalation of APG-5918. Part 2 is the dose expansion of APG-5918. APG-5918 will be administered orally. Patients will be treated in 28-day cycles.

Detailed Description

The dose escalation part is to establish the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) when APG-5918 is given orally once daily in subjects with histologically- and/or cytologically-confirmed advanced solid tumors or non-Hodgkin's lymphoma (NHL) that have progressed or are intolerant after treatment with approved therapies or for which there are no standard therapies available. The starting dose of APG-5918 is 50 mg; the doses can be modified depending on toxicity and pharmacokinetic (PK) results based on discussions with the Investigators and Sponsor. If no dose-limiting toxicities (DLTs) or less than two drug related Grade 2 toxicities are observed by the end of Cycle 1, the dose of APG-5918 will be increased in subsequent cohorts. The dose expansion part will be initiated once the MTD or RP2D is established. Approximately 9-12 subjects will be enrolled into two cohorts treating with the appropriate two dose levels at (MTD-1 and MTD) or below MTD (MTD-2 and MTD-1), depending on the comprehensive analysis of the PK, pharmacodynamic (PD), safety and efficacy data of APG-5918. Patients will be randomized 1:1 to each dose cohort.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 in dose escalation or 0 to 2 in dose expansion
•Has a life expectancy of \>3 months
•Has a malignancy: with histologically or cytologically confirmed locally advanced or metastatic solid tumors or relapsed or refractory Non-Hodgkin's Lymphoma (NHL) who have disease progression after treatment with available therapies that are known to confer clinical benefit.
•1. has measurable disease based on RECIST 1.1 for advanced solid tumors including but not limited to nasopharyngeal carcinoma, castration-resistant prostate cancer, gastric cancer, ovarian clear cell carcinoma, mesothelioma, and sarcoma
•2. has measurable disease based on Non-Hodgkin's Lymphoma Cheson response criteria for NHL
•For subjects with B cell lymphoma: has documented EZH2 mutation status or be willing to perform EZH2 mutation status testing
•For subjects with sarcoma: patients with epithelioid sarcoma or sarcoma with confirmed evidence of aberrant SMARCB1 status is preferred
•For subjects with prostate cancer: patients must have evidence of castration resistance (as evidenced by confirmed elevated prostate-specific antigen (PSA) (per Prostate Cancer Working Group \[PCWG3\] criteria) and serum testosterone of castrate levels (i.e. ≤ 50 ng/dL))
•Adequate hematologic function defined as:
•1. ANC ≥1.0 x 10˄9/L independent of growth factor support within 7 days of the first dose with study drug
+16 more criteria

Exclusion Criteria

•Receiving concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, with the exception of hormones for hypothyroidism or estrogen replacement therapy (ERT), anti-estrogen analogs, agonists required to suppress serum testosterone levels); or any investigational therapy within 14 days or 5 times of half-life of the molecule prior to the first dose of study drug
•Steroid therapy for anti-neoplastic intent within 7 days prior to the first dose of the study drug
•Continuance of toxicities due to prior radiotherapy, targeted therapy, immunotherapy or chemotherapeutic agents that do not recover to \< Grade 2, except alopecia or leukodermia
•Has gastrointestinal conditions that could affect the absorption of APG-5918 in the opinion of the Investigator
•Use of therapeutic doses of anti-coagulants is excluded, along with antiplatelet agents; low-dose anticoagulation medications that are used to maintain the patency of a central intravenous catheter are permitted
•Received a biologic (G-CSF, GM-CSF, or erythropoietin) within 7 days prior to the first dose of the study drug
•Failure to recover adequately, as judged by the investigator, from prior surgical procedures. Patients who have had major surgery within 28 days from study entry, and patients who have had minor surgery within 14 days of study entry.
•Severe cardiac conditions defined as:
•1. New York Heart Association (NYHA) class III or IV cardiac disease, including preexisting uncontrolled clinically significant arrhythmia, congestive heart failure, or cardiomyopathy
•2. Unstable angina, myocardial infarction, or a coronary revascularization procedure within ≤ 3 months prior to initiation of study treatment
+14 more criteria

Locations (1)

Highlands Oncology

Springdale, Arkansas, United States

Key Dates

Start Date

September 30, 2022

Primary Completion Date

September 30, 2024

Completion Date

September 30, 2025

Last Updated

November 16, 2022

Enrollment

ESTIMATED participants

Conditions

Nasopharyngeal CarcinomaCastrate Resistant Prostate CancerGastric CancerOvarian Clear Cell CarcinomaMesotheliomaSarcomaNon Hodgkin LymphomaB Cell LymphomaEpithelioid Sarcoma

Interventions

APG-5918

DRUG

Contacts

Wendy Chu

CONTACT

240-278-6373 wendy.chu@ascentage.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 16, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas

Inclusion Criteria

Exclusion Criteria

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