What side effects are associated with this type of intervention?

Common treatments for sarcoma, particularly those involving targeted therapies and antiangiogenic agents, often result in a range of side effects. These can include hypertension, hypothyroidism, diarrhea, hand-foot syndrome, and skin rashes. Additionally, treatments like pazopanib, which is an antiangiogenic agent, may cause cardiovascular effects such as hypertension and non-cardiovascular effects like diarrhea and hypothyroidism. Other side effects observed in similar treatments include fatigue, proteinuria, and elevated liver enzymes (AST or ALT).

What prior FDA approvals exist?

Several targeted therapies have been approved by the FDA for the treatment of sarcoma. Pazopanib, a tyrosine kinase inhibitor targeting VEGF receptors, is approved for advanced soft tissue sarcoma (STS) after prior chemotherapy. Regorafenib, another tyrosine kinase inhibitor, has shown activity in nonadipocytic STS. Additionally, nab-sirolimus, an mTOR inhibitor, is approved for advanced malignant PEComa, a subtype of sarcoma. These approvals highlight the trend towards targeted therapies in the treatment of sarcoma.

What other types of research exist?

Promising novel alternatives for sarcoma patients include VEGFR inhibitors like pazopanib, mTOR inhibitors such as sirolimus, and combination therapies involving chemotherapy agents like doxorubicin and ifosfamide. Additionally, immunotherapy approaches and targeted therapies like olaratumab (a PDGFRα antagonist) are also being explored.

← Back to Search

Other

APG-5918 for Cancer

Q: What is the mechanism of action of this treatment?

Common treatments for sarcoma include chemotherapy, radiation therapy, and investigational agents. Chemotherapy works by targeting rapidly dividing cells, disrupting their DNA replication and cell division processes, which is crucial for shrinking tumors and preventing metastasis. Radiation therapy damages the DNA of cancer cells, leading to cell death and reduced tumor size. Investigational agents, such as APG-5918, often target specific molecular pathways involved in cancer cell growth and survival, offering a more tailored approach. Understanding these mechanisms helps in selecting the most effective treatment plan, minimizing side effects, and improving patient outcomes.

Phase 1

Recruiting

Research Sponsored by Ascentage Pharma Group Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Has measurable disease based on Non-Hodgkin's Lymphoma Cheson response criteria for NHL

Must not have

Prior treatment with embryonic ectoderm development (EED) inhibitors, Concurrent treatment with QT interval-prolonging drugs, Medical history of Torsades de Pointes, Patients with known or suspected allergy or hypersensitivity to drugs/compounds similar in composition to APG-5918 or other EED inhibitors, Any other condition or circumstance of that would, in the opinion of the investigator, make the patient unsuitable for participation in the study, Other malignant diseases than the ones being treated in this study with the exception of: cured malignancy without recurrence within 3 years prior to study entry; completely resected basal cell and squamous cell skin cancer; completely resected carcinoma in situ of any type, Non-Hodgkin lymphoma patients who have received prior allogeneic stem cell transplant, Severe and/or uncontrolled medical conditions that in the investigator's opinion could affect the safety of individual or impair the assessment of study result, Long-term steroid therapy, except for the following: 10 mg prednisone (or equivalent) daily or lower doses of steroids for control of nausea, vomiting, active autoimmune disease and seasonal allergies or prevention of adrenocortical insufficiency Note: topical steroids or inhaled steroids are allowed, Pregnant (confirmed by human chorionic gonadotropin (HCG) testing) or lactating women

Continuance of toxicities due to prior radiotherapy, targeted therapy, immunotherapy or chemotherapeutic agents that do not recover to < Grade 2, except alopecia or leukodermia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new oral drug, APG-5918, for patients with advanced solid tumors or non-Hodgkin's lymphoma who have no other treatment options. The goal is to find the safest and most effective dose by adjusting it over time and monitoring the patients.

Who is the study for?

This trial is for adults with advanced solid tumors or lymphomas, including specific cancers like nasopharyngeal and prostate cancer, who have not responded to existing treatments. Participants must be expected to live more than 3 months, have a certain level of physical fitness (ECOG status), and measurable disease. They should also have adequate organ function and agree to use effective contraception.

What is being tested?

The study tests APG-5918's safety and effectiveness in two parts: dose escalation followed by dose expansion. It involves patients taking the drug orally in cycles lasting 28 days each.

What are the potential side effects?

While the side effects are not explicitly listed here, common ones for cancer drugs taken orally include nausea, vomiting, diarrhea, fatigue, liver toxicity which may affect blood test results, potential heart issues reflected in ECG changes, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer has spread or returned and doesn't respond to treatment anymore.

Select...

My lymphoma can be measured for treatment response.

Select...

My prostate cancer is resistant to hormone therapy, shown by rising PSA levels despite low testosterone.

Select...

My B cell lymphoma has been tested for the EZH2 mutation, or I am willing to have this test.

Select...

My blood counts meet the required levels for the study drug.

Select...

I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My side effects from previous cancer treatments are mild, except for hair loss or skin color changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose-limiting Toxicity (DLT)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2 in Dose expansionExperimental Treatment1 Intervention

Group II: Cohort 1 in Dose expansionExperimental Treatment1 Intervention

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for sarcoma include chemotherapy, radiation therapy, and investigational agents. Chemotherapy works by targeting rapidly dividing cells, disrupting their DNA replication and cell division processes, which is crucial for shrinking tumors and preventing metastasis. Radiation therapy damages the DNA of cancer cells, leading to cell death and reduced tumor size. Investigational agents, such as APG-5918, often target specific molecular pathways involved in cancer cell growth and survival, offering a more tailored approach. Understanding these mechanisms helps in selecting the most effective treatment plan, minimizing side effects, and improving patient outcomes.