Oral Cancer Drug for Squamous Cell Carcinoma

Overseen By Medical College of Wisconsin Cancer Center Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Medical College of Wisconsin

Must not be taking: Herbal compounds

Disqualifiers: Active liver disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1-4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an oral cancer drug called Antitumor B KAC for individuals with squamous cell carcinoma of the oral cavity. The goal is to understand the drug's behavior in the body (its pharmacokinetics) and its biological effects before cancer surgery. The trial includes those recently diagnosed or with a new or returning case who can undergo surgery to remove the cancer. Participants must have a specific diagnosis of oral cavity squamous cell cancer and be ready to start the study medication shortly after joining the trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot use any herbal or natural compounds that might affect the study results. It's best to discuss your current medications with the study team.

Is there any evidence suggesting that Antitumor B KAC is likely to be safe for humans?

A previous study tested the treatment Antitumor B KAC in patients with oral cancer. The results showed that most patients handled the treatment well, with no major safety issues. This suggests that Antitumor B KAC might be safe for humans. However, the current trial is in an early stage and focuses on understanding how the drug works in the body. Researchers are still gathering detailed safety information. It is important to discuss any potential risks with a doctor before deciding to join. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Antitumor B KAC for squamous cell carcinoma because it introduces a novel approach to treatment. Unlike traditional options like surgery, radiation, and chemotherapy, which often come with significant side effects and long recovery times, Antitumor B KAC is an oral medication that can be administered on an outpatient basis. This convenience allows patients to maintain their daily routines while receiving treatment. Additionally, Antitumor B KAC targets tumor cells more precisely, potentially reducing collateral damage to healthy cells and leading to fewer side effects. This targeted approach could revolutionize the way squamous cell carcinoma is treated, offering a more patient-friendly option.

What evidence suggests that Antitumor B KAC might be an effective treatment for squamous cell carcinoma?

Research has shown that Antitumor B KAC, the investigational treatment in this trial, holds promise for treating squamous cell carcinoma, a type of oral cancer. Early studies have examined the drug's movement through the body and its absorption, aiding scientists in predicting its effectiveness. Although limited data from human studies exist, the drug is designed to target cancer cells and inhibit their growth. Researchers remain hopeful because similar treatments have performed well in related cancers, such as head and neck squamous cell carcinoma. Further studies will help confirm these early findings. ^{2 3 6 7 8}

Who Is on the Research Team?

Stuart J. Wong, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

Adults diagnosed with oral cavity squamous cell cancer, fit for surgery (stage II-IVA), and have good organ function. They must not be pregnant or breastfeeding, agree to use contraception if of childbearing potential, and can't have had certain prior treatments for oral SCC. No severe comorbidities like uncontrolled heart disease or severe COPD.

Inclusion Criteria

Study agent administration should start within seven days of registration

I am following the required birth control measures.

Patients must be deemed able to comply with the study plan

Exclusion Criteria

Pregnant or lactating women

I have a history of active liver disease.

I am currently taking prescribed medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive the natural botanical compound ATB-KAC and provide blood and saliva samples during administration

1-4 weeks

Multiple visits for sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Antitumor B KAC

Trial Overview The trial is testing Antitumor B KAC's effects on patients with squamous cell carcinoma during the short period between their diagnosis and surgery. It focuses on how the body processes the drug (pharmacokinetics).

How Is the Trial Designed?

Group I: Antitumor B KAC Experimental Treatment 1 Intervention

ATB will be administered on an outpatient basis.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10607708/

Pharmacokinetic Characterization and Bioavailability Barrier ... The purpose of the present study was to characterize the pharmacokinetics profiles and identify important bioavailability barriers and pharmacological pathways

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9389441/

Outcomes Among Patients With Mucosal Head and Neck ... This cohort study assesses survival outcomes and response rates among patients with recurrent or metastatic mucosal head and neck squamous cell carcinoma ...

3. go.drugbank.com go.drugbank.com/conditions/DBCOND0046498

Squamous Cell Carcinoma of the Oral Cavity ... - DrugBank Associated Data ; NCT02331875. Efficacy Study of Pre-operative IPH2201 in Patients With Squamous Cell Carcinoma of the Oral Cavity. Monalizumab ; NCT06627270.

4. hollingscancercenter.musc.edu hollingscancercenter.musc.edu/news/archive/2021/10/21/hollings-collaborates-on-two-studies-showing-how-to-boost-immunotherapy-effectiveness

Hollings collaborates on two studies showing how to boost ... Two new studies revealed that anti-PD-1 immunotherapy given before surgery was safe and effective for patients with oral-cavity squamous cell carcinoma (OCSCC).

5. onclive.com onclive.com/view/pembrolizumab-plus-chemo-elicits-responses-in-head-and-neck-squamous-cell-carcinoma

Pembrolizumab Plus Chemo Elicits Responses in Head ... The disease control rate achieved with the combination was 75% (95% CI, 65.7%-83.3%). “In summary, pembrolizumab in combination with paclitaxel ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05452408

Study Details | NCT05452408 | Antitumor-B KAC PK Study Inclusion Criteria: Clinical diagnosis of oral cavity squamous cell cancer. Patient can start study agent administration but histological confirmation of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10135659/

Oral Cavity Squamous Cell Carcinoma: An Update of the ... The authors concluded that neoadjuvant nivolumab is safe and well-tolerated and could be proposed as neoadjuvant therapy for OCSCC patients [54] ...

8. malacards.org malacards.org/card/squamous_cell_carcinoma_head_and_neck

Squamous Cell Carcinoma, Head and Neck (HNSCC) HNSCC can spread (metastasize) to other parts of the body, such as the lymph nodes or lungs. If it spreads, the cancer has a worse prognosis and can be fatal.