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APG-5918 for Cancer

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a new drug, APG-5918, in people with cancer. The drug will be given orally in 28-day cycles. The trial will have two parts: first, a dose escalation to test safety, and second, a dose expansion to test effectiveness.

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.Check my eligibility
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.See study design
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
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose-limiting Toxicity (DLT)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2 in Dose expansionExperimental Treatment1 Intervention
Group II: Cohort 1 in Dose expansionExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Ascentage Pharma Group Inc.Lead Sponsor
46 Previous Clinical Trials
4,244 Total Patients Enrolled
Yifan Zhai, MD, PhDStudy ChairAscentage Pharma Group Inc.
18 Previous Clinical Trials
1,216 Total Patients Enrolled

Media Library

APG-5918 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05415098 — Phase 1
Sarcoma Research Study Groups: Cohort 1 in Dose expansion, Cohort 2 in Dose expansion
Sarcoma Clinical Trial 2023: APG-5918 Highlights & Side Effects. Trial Name: NCT05415098 — Phase 1
APG-5918 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05415098 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate amount of people who have elected to partake in this experiment?

"Affirmative. According to the information available on clinicaltrials.gov, this medical investigation is actively seeking participants; it was first posted on September 30th 2022 and has been recently updated on November 11th 2022. A total of 90 individuals are needed from 2 trial sites."

Answered by AI

Are any openings available for participation in this trial?

"Per the latest information from clinicaltrials.gov, this trial is open and actively recruiting participants. The initial posting took place on September 30th 2022 with a recent update happening November 11th 2022."

Answered by AI

Is APG-5918 a potential risk factor to the general population?

"As this is an early Phase I trial, APG-5918's safety was rated at a 1. This assessment is based on limited evidence concerning the drug's effectiveness and its potential to cause harm."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
Indiana
New York
Other
How old are they?
18 - 65
65+
What site did they apply to?
Yale University
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas
2022. "Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05415098.
All > Nasopharyngeal Carcinoma > Sarcoma
~19 spots leftby Sep 2024
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