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APG-157 for Head and Neck Cancer
Phase 2
Recruiting
Led By Marilene B Wang, MD
Research Sponsored by Aveta Biomics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Newly diagnosed, treatment naive Stage I, Stage II, Stage III or Stage IV HNSCC patients with acceptable TNM staging
Biopsy proven oral cavity or oropharyngeal Squamous Cell Carcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of dosing is four weeks (extendable up to 6 weeks) of apg-157 dosing. baseline is at time of diagnosis. end of dosing is day before surgery or start of other definitive therapy and/or radiation
Awards & highlights
Study Summary
This trial will study the safety and effectiveness of a new drug, APG-157, as a treatment for head and neck cancer. The hypothesis is that the new drug will reduce the tumor burden and improve outcomes.
Who is the study for?
This trial is for newly diagnosed patients with Squamous Cell Carcinoma in the oral cavity or oropharynx. They should be treatment-naive, have no metastatic cancer, and not scheduled for definitive local therapy within four weeks. Excluded are pregnant women, those who've had recent chemotherapy, radiation, or surgery of the mouth, as well as individuals with mental status issues that prevent form completion.Check my eligibility
What is being tested?
The trial tests APG-157 as an oral pre-treatment (neoadjuvant) to reduce tumor size before main treatment in head and neck cancer patients. It aims to see if this approach can improve outcomes compared to current standard treatments alone.See study design
What are the potential side effects?
While specific side effects of APG-157 aren't listed here, common ones may include digestive discomforts like nausea or diarrhea; fatigue; possible allergic reactions; and changes in blood counts leading to increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have newly diagnosed head and neck cancer that has not been treated yet.
Select...
I have been diagnosed with oral or throat cancer through a biopsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to end of dosing is four weeks (extendable up to 6 weeks) of apg-157 dosing. baseline is at time of diagnosis. end of dosing is day before surgery or start of other definitive therapy and/or radiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of dosing is four weeks (extendable up to 6 weeks) of apg-157 dosing. baseline is at time of diagnosis. end of dosing is day before surgery or start of other definitive therapy and/or radiation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Imaging to assess drug's ability to impact tumor size
Secondary outcome measures
Biopsy
Cell-free RNA analyses of saliva and blood
Saliva Profile
Trial Design
1Treatment groups
Experimental Treatment
Group I: APG-157Experimental Treatment1 Intervention
Two pastilles (100 mg) taken three times a day (i.e. before meal time).
Find a Location
Who is running the clinical trial?
Aveta Biomics, Inc.Lead Sponsor
3 Previous Clinical Trials
62 Total Patients Enrolled
Marilene B Wang, MDPrincipal InvestigatorVA Los Angeles/UCLA
Elizabeth Franzmann, MDPrincipal InvestigatorUniversity of Miami Sylvester Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have newly diagnosed head and neck cancer that has not been treated yet.My doctor considers my mouth or throat condition significant.I can start treatment within 4 weeks of my diagnosis.I have bleeding gums or cracked teeth.I have been diagnosed with oral or throat cancer through a biopsy.I haven't had chemotherapy or radiation in the last 8 weeks.I have had a jaw fracture in the last 8 weeks.My cancer has returned or spread to other parts of my body.I have a tooth abscess.I had oral, dental, or gum surgery in the last 8 weeks.I am scheduled for specific treatments after APG-157, including surgery or radiation for cure or palliation.
Research Study Groups:
This trial has the following groups:- Group 1: APG-157
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there any opportunity for people to participate in this experiment?
"Affirmative. Details found on clinicaltrials.gov show that this medicinal inquiry, which was first published on April 22nd 2022, is currently enlisting participants. A total of 24 volunteers must be sourced from 2 medical facilities."
Answered by AI
Is APG-157 a safe option for individuals to consider?
"Given the lack of efficacy information from Phase 2 trials, APG-157 was assigned a score of 2 in terms of safety on our team's scale."
Answered by AI
What is the current enrollment of participants in this investigation?
"Affirmative. The clinical trial website displays that this medical research, which was first advertised on April 22nd 2022, is still actively looking for participants. 24 people are required to be found at two different locations."
Answered by AI
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