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Head and Neck CancerPhase 2NCT05312710

Safety and Efficacy of APG-157 in Head and Neck Cancer

A Phase 2 study testing APG-157 in people with Head and Neck Cancer and Squamous Cell Carcinoma of Oral Cavity, run by Aveta Biomics, Inc. at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this clinical research study is to study safety and efficacy of orally administered APG-157 as the neoadjuvant/induction therapy in newly diagnosed, locally advanced patients with Head \& Neck Cancer of oral cavity and/or oropharynx. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
APG-157
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesUnited States
Study dates
22 Apr 2022to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Biopsy proven oral cavity or oropharyngeal Squamous Cell Carcinoma.
  • Newly diagnosed, treatment naive Stage I, Stage II, Stage III or Stage IV HNSCC patients. Staging is done according to the International Union Against Cancer's (UICC) classification system for oral cancer. Acceptable TNM staging is T1-4, N0-2, M0.
  • Patients who are scheduled to receive the following therapy after APG-157 treatment.
  • Local Therapy with Curative Intent Surgery alone or surgery followed by radiation.
  • Therapy with Palliative Intent Radiation alone. Radiation with concurrent radiosensitizing chemotherapeutic agents only using QUAD-shot protocol. Radiosensitizing chemotherapeutic agents are limited to carboplatin or cetuximab.
  • Patients who refuse surgery or are unfit for any local therapy.

Who cannot join

  • Patients whose definitive, local treatment is available in less than four weeks from initial diagnosis. For example, some patients who are scheduled to receive chemo-radiation therapy as the local therapy with curative intent.
  • Pregnant women.
  • Prior Chemotherapy or radiation therapy within the last 8 weeks.
  • Patients with recurrent or metastatic cancer.
  • Tooth abscesses.
  • Bleeding gums or cracked teeth.
Show all 10Show fewer
  • Patients who have had surgery of the oral cavity, teeth, or gums within the previous 8 weeks.
  • Patients who have had a fracture of the mandible or maxilla within the previous 8 weeks.
  • Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness).
  • Patients with other related diseases or the oral cavity or oropharynx, as determined to be significant by the PI.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • VAGLAHS, West Los Angeles

    Los Angeles, California, 90073

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

Other trials in United States

About this study

Official title: Phase 2 Study to Evaluate the Safety and Efficacy of APG-157 as Neoadjuvant/Induction Therapy for Patients With Head and Neck Squamous Cell Cancer (HNSCC) of the Oral Cavity and/or Oropharynx

The purpose of this clinical research study is to study safety and efficacy of orally administered APG-157 as the neoadjuvant/induction therapy in newly diagnosed, locally advanced patients with Head \& Neck Cancer of oral cavity and/or oropharynx.

The study hypothesis is that neoadjuvant use of APG-157 will reduce the tumor burden prior to any definitive therapy to improve the outcomes over current standard of care.

Read the detailed description

The patient will receive neoadjuvant therapy (APG-157) during the period between initial diagnosis and time of definitive treatment. APG-157 is an orally administered drug in a form of pastille (soft lozenge) taken three times a day. It dissolves in the mouth. After the neoadjuvant treatment, the patient undergoes surgery or any other definitive therapy and/or postoperative radiotherapy as determined by the patient's doctor. Duration of treatment is four weeks that may be extended up to six weeks by mutual consent of the patients and the investigators.

Objectives:

  1. To conduct Phase 2A to determine how tumor size, tumor tissue biomarkers, and the cancer stem cell markers, in head and neck squamous cell cancer patients are affected by the administration APG-157 pastilles using imaging and other clinical measurements.
  2. To determine the degrees of response of each patient to APG-157 (considering patient's diagnosis/staging and local treatment) using proposed primary, secondary and exploratory endpoints.
  3. The results from this study will be used to finalize the design of subsequent Phase 2B study (single arm for specific patient population and local treatment) to demonstrate statistically significant efficacy outcomes.
Being tested
APG-157
Keywords
Neoadjuvant, Induction Therapy, Oral Cancer, Oropharyngeal Cancer
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Mouth Neoplasms, Oropharyngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • APG-157Drug

    Treatment

Study groups in NCT05312710
Study groupRoleWhat they receive
APG-157ExperimentalTwo pastilles (100 mg) taken three times a day (i.e. before meal time).
Receives: Drug: APG-157

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Imaging to assess drug's ability to impact tumor size

    Change in Tumor Size from Baseline to end of dosing using MRI with or without contrast and PET/CT imaging.

    Measured: 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

Secondary outcomes (3)

  1. Biopsy

    Change in Immunohistochemistry profile (including the levels of tumor infiltrating lymphocytes TILs) of tumor biopsy from baseline to end of dosing.

    Measured: 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

  2. Saliva Profile

    Change in cytokine levels (IL-1β , TNF-α, IL-8) and oral microbiome (phyla and genus level changes in microbial composition using 16s RNA sequencing) in saliva from baseline to end of dosing.

    Measured: 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

  3. Cell-free RNA analyses of saliva and blood

    Change in cell-free RNA biomarkers in blood and saliva from baseline to end of dosing.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2022
  2. Study start22 Apr 2022
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05312710
Sponsor's protocol ID
AVTA 20-01
Status last verified
Jan 2026
First submitted
16 Mar 2022
Last updated
16 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing APG-157 in people with Head and Neck Cancer and Squamous Cell Carcinoma of Oral Cavity, run by Aveta Biomics, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Imaging to assess drug's ability to impact tumor size (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05312710.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.

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