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Squamous Cell Carcinoma of the Oral CavityPhase 1NCT05452408

Antitumor-B KAC PK Study

A Phase 1 study testing Antitumor B KAC in people with Squamous Cell Carcinoma of the Oral Cavity, run by Medical College of Wisconsin at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Study Design: A Window of Opportunity Clinical Trial. This study design permits examination of effects of an oral agent on cancer patients during the "window" between diagnosis of their cancer and their definitive cancer surgery. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Antitumor B KAC
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Dec 2026to Dec 2027
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Clinical diagnosis of oral cavity squamous cell cancer.
  • Patient can start study agent administration but histological confirmation of squamous cell cancer (SCC) of the oral cavity (or histologic variants of SCC) by the pathologist must happen within seven days of registration in order to continue study agent administration.
  • Clinical stage II-IVA (as defined by the AJCC, 8th Edition) and amenable to surgical resection.
  • New diagnosis of oral SCC, new second primary, or recurrent oral SCC following a minimum remission of six months following previous definite surgery.
  • History and physical examination by an otolaryngologist and medical oncologist within 30 calendar days of study registration.
  • Study agent administration should start within seven days of registration.
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  • Patient must receive administration of study agent for a minimum of seven days.
  • ECOG Performance status < 2.
  • Age ≥ 18 years.
  • CBC/differential obtained within 30 calendar days prior to registration, with adequate bone marrow function defined as follows:
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dL (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable.);
  • Adequate renal and hepatic function within 30 calendar days prior to registration, defined as follows:
  • Serum creatinine < 1.5 mg/dL or creatinine clearance (CrCl) ≥ 50 mL/min within 14 calendar days prior to registration, determined by 24-hour collection or estimated by Cockcroft-Gault formula:
  • CrCl male = [(140 - age) x (weight in kg)], [(Serum Cr mg/dL) x (72)] CrCl female = 0.85 x (CrCl male)
  • Total bilirubin < 2 x the institutional ULN within 30 calendar days prior to registration.
  • AST or ALT ≤ 3 x the institutional ULN within 30 calendar days prior to registration.
  • Glucose, potassium, and sodium within 30 calendar days prior to registration, with the following required parameters:
  • Glucose: > 40 mg/dL or < 250 mg/dL; Potassium: > 3 mmol/L or < 6 mmol/L; Sodium: > 130 mmol/L or < 155 mmol/L.
  • Female patients must meet one of the following:
  • Postmenopausal for at least one year before the screening visit, or
  • Surgically sterile (i.e., undergone a hysterectomy or bilateral oophorectomy), or
  • If subject is of childbearing potential (defined as not satisfying either of the above two criteria), agree to practice two acceptable methods of contraception (combination methods requires use of two of the following: diaphragm with spermicide, cervical cap with spermicide, contraceptive sponge, male or female condom, hormonal contraceptive) from the time of signing of the informed consent form through 90 days after the last dose of study agent, AND o Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptom-thermal, post ovulation methods] and withdrawal are not acceptable contraception methods.)
  • Male patients, even if surgically sterilized (i.e., status postvasectomy), must agree to one of the following:
  • Practice effective barrier contraception during the entire study period and through 60 calendar days after the last dose of study agent, OR
  • Must also adhere to the guidelines of any study-specific pregnancy prevention program, if applicable, OR
  • Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptom-thermal, post ovulation methods] and withdrawal are not acceptable methods of contraception.)
  • Patients must be deemed able to comply with the study plan.
  • Gastric tube study agent administration is permissible.
  • Patients must provide study-specific informed consent prior to study entry.

Who cannot join

  • History of active liver disease.
  • Pregnant or lactating women are ineligible due to unforeseeable risks to embryo or fetus.
  • Concurrent use of any medicinal botanical, natural, or other herbal compound/s that the study PI believes could potentially have an impact on the results/objectives of this study.
  • Planned subtotal or debulking surgery, as determined by enrolling physician determination, is not permissible.
  • Prior systemic chemotherapy for oral SCC; note that prior chemotherapy for a different cancer is allowable.
  • Prior radiotherapy for oral SCC is permissible if disease free for one year since prior oral cancer treatment and free of significant late radiation effects.
  • Severe active comorbidity, such as uncontrolled cardiac disease, infection, severe COPD.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Froedtert Hospital and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

Other trials in United States

About this study

Official title: PK Analysis of Antitumor B KAC in Patients with Oral Cancer

Study Design: A Window of Opportunity Clinical Trial. This study design permits examination of effects of an oral agent on cancer patients during the "window" between diagnosis of their cancer and their definitive cancer surgery. Similar to a phase 0 study, the trial design permits examination of the biologic effects of an agent; in this study pharmacokinetic properties will be examined.

Read the detailed description

Study Rationale: Establishing the PK profile for antitumor B key active components (ATB-KAC) is a critical initial step before future clinical trials can be performed that examine anticancer and cancer preventive effects of ATB-KAC.

Study Intervention Description: Study participants will take the natural botanical compound ATB-KAC during a short window (seven to 28 days). Participants will provide blood samples and saliva samples during ATB-KAC administration and a portion of the initial tumor biopsy.

Being tested
Antitumor B KAC
Keywords
Antitumor B KAC, Antitumor B Key Active Components
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

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

  • Antitumor B KACDrug

    ATB-KAC will be administered at a dose of 720 mg three times per day (roughly spaced every eight hours) as has been studied for ATB-KAC in human oral leukoplakia trials and in esophageal cancer prevention trials. ATB-KAC may be taken with or without food.

Study groups in NCT05452408
Study groupRoleWhat they receive
Antitumor B KACExperimentalATB will be administered on an outpatient basis.
Receives: Drug: Antitumor B KAC

What is being measured

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

  1. Area under the Curve (AUC) for Saliva

    The AUC will be calculated. The calculation will be mg/ml X hour.

    Measured: predose, 30, 60, 120, 180, 240, 360, 480, and 1,440 min on Day 1

  2. Area under the Curve for Plasma

    The AUC will be calculated. The calculation will be mg/ml X hour.

    Measured: predose, 30, 60, 120, 180, 240, 360, 480, and 1,440 min on Day 1

  3. Cmax for Saliva

    The Cmax will be calculated. The calculation will be ng/ml.

    Measured: Day 1

  4. Cmax for Plasma

    The Cmax will be calculated. The calculation will be ng/ml.

    Measured: Day 1

Timeline

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

  1. First posted11 Jul 2022
  2. Study startDec 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Why it stopped: Study abandoned.

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05452408
Sponsor's protocol ID
IIT-WONG-ATB-KAC
Status last verified
Mar 2025
First submitted
6 Jul 2022
Last updated
18 Mar 2025
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 1 study testing Antitumor B KAC in people with Squamous Cell Carcinoma of the Oral Cavity, run by Medical College of Wisconsin at 1 site 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 29 inclusion and 7 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: withdrawn, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Area under the Curve (AUC) for Saliva (time frame: predose, 30, 60, 120, 180, 240, 360, 480, and 1,440 min on Day 1). The study lists 4 primary outcomes in all. 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 NCT05452408.

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 18 Mar 2025.

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