Antitumor B KAC-α PK Study

RATIONALE: Establishing the pharmacokinetics (PK) profile for Antitumor B Key Active
Component (ATB-KAC-α) is a critical initial step before future clinical trials can be
performed that examine anti-cancer and cancer preventive effects of ATB-KAC-α.

PRIMARY OBJECTIVE: To examine the pharmacokinetic properties of ATB-KAC-α.

Inclusion Criteria:

- 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 7 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 6 months following previous definite surgery

- History and physical examination by an otolaryngologist and medical oncologist within
14 calendar days of study registration

- Study agent administration should start within 7 days of registration

- Patient must receive administration of study agent for a minimum of 7 days

- Zubrod/ECOG Performance status < 2.

- Age ≥ 18 years.

- CBC/differential obtained within 14 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 14 calendar days prior to registration,
defined as follows:

o Serum creatinine < 1.5 mg/dl or creatinine clearance (CCr) ≥ 50 ml/min within 14
calendar days prior to registration, determined by 24-hour collection or estimated by
Cockcroft-Gault formula: CCr male = [(140 - age) x (wt in kg)] [(Serum Cr mg/dl) x
(72)] CCr female = 0.85 x (CrCl male)

- Total bilirubin < 2 x the institutional ULN within 14 calendar days prior to
registration

- AST or ALT ≤ 3 x the institutional ULN within 14 calendar days prior to registration

- Magnesium, calcium, glucose, potassium, and sodium within 14 calendar days prior to
registration, with the following required parameters:

- Magnesium: > 0.9 mg/dl or < 3 mg/dl;

- Calcium: > 7 mg/dl or < 12.5 mg/dl;

- 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

- 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,
symptothermal, postovulation methods] and withdrawal are not acceptable
contraception methods.)

- Male patients, even if surgically sterilized (i.e., status post vasectomy), 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,
symptothermal, 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.

Exclusion Criteria:

- 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 impact 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 1 year since prior
oral cancer treatment and free of significant late radiation effects.

- Severe active comorbidity such as uncontrolled cardiac disease, infection, severe
COPD.