CLINICAL TRIAL

ST-067 for Oral Squamous Cell Carcinoma

Locally Advanced
Metastatic
Recruiting · 18+ · All Sexes · Portland, OR

This study is evaluating whether a drug called ST-067 can be safely given to people with cancer.

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About the trial for Oral Squamous Cell Carcinoma

Eligible Conditions
Melanoma · Carcinoma, Renal Cell · Tumors, Solid · Triple Negative Breast Neoplasms · Renal Cell Adenocarcinoma · Triple-negative Breast Cancer · Squamous Cell Carcinoma of the Head and Neck · Malignancies · Carcinoma · Non-Small Cell Lung Carcinoma (NSCLC) · Squamous Cell Carcinoma of Head and Neck

Treatment Groups

This trial involves 2 different treatments. ST-067 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Experimental Group 1
ST-067
BIOLOGICAL
Experimental Group 2
ST-067
BIOLOGICAL

Eligibility

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Male and female patients aged ≥18 years
Must provide written informed consent and any authorizations required by local law
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Have histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumor For Phase 1a, the following solid tumors are allowed: Melanoma, Merkel cell, RCC, urothelial, NSCLC,TNBC, SCCHN, microsatellite instability high, high tumor mutation burden (Hi TMB) or mismatch repair deficient, gastric, cervical, endometrial, cutaneous squamous, small cell lung, esophageal, hepatocellular carcinoma and platinum resistant ovarian cancer.
For patients whom standard of care therapy that prolongs survival is not available or suitable (according to the investigator and after consultation with the Medical Monitor)
Melanoma, RCC, TNBC, NSCLC, SCCHN, and MSI-Hi tumors
Has at least 1 measurable lesion per RECIST 1.1 criteria which has not been biopsied or received prior irradiation
Has an accessible tumor for biopsy pre- and on-treatment (mandatory).
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Day 29
Screening: ~3 weeks
Treatment: Varies
Reporting: Day 29
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Day 29.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether ST-067 will improve 3 primary outcomes and 2 secondary outcomes in patients with Oral Squamous Cell Carcinoma. Measurement will happen over the course of At 8 weeks.

Initial assessment of efficacy in phase 2
AT 8 WEEKS
Investigator-assessed ORR, defined as either a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on computed tomography (CT) or magnetic resonance imaging (MRI) scans
AT 8 WEEKS
Determine the maximum tolerated dose of ST-067 in phase 1a
DAY 29
6 to 12 patients have been enrolled at a dose level that is predicted to be the MTD
DAY 29
ADA
DAY 29
Incidence of ADA to ST-067
DAY 29
PK
DAY 29
Peak Plasma Concentration (Cmax)
DAY 29
Number of Participants With Treatment-Related Adverse Events
DAY 29
AE assessed by CTCAE 5.0
DAY 29

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who should consider clinical trials for oral squamous cell carcinoma?

Recent findings and the lack of evidence to support the use of clinical trials point to the lack of evidence to support the routine use of clinical trials for patients with oral squamous cell carcinoma.

Anonymous Patient Answer

How serious can oral squamous cell carcinoma be?

The mortality rate is approximately 1% and the 5-year survival rate can be as high as 85%. The long-term prognosis is poor for people who have cancer to the tongue or gums.

Anonymous Patient Answer

What are common treatments for oral squamous cell carcinoma?

There is not any specific treatment to treat the oropharyngeal [head and neck cancer](https://www.withpower.com/clinical-trials/head-and-neck-cancer). Radical surgery to remove the cancer and surgery and/or radiation therapy to protect the remaining parts of the throat and neck are the common treatment options. If the cancer does not come out after an operation, radiation or chemoradiotherapy may be used to manage the cancer.

Anonymous Patient Answer

What are the signs of oral squamous cell carcinoma?

Data from a recent study has reported a range of clinical presentation of OSCC. The most common symptom of OSCC is a sore patch. Clinically suspicious skin lesions should be promptly investigated; otherwise, OSCC is difficult to diagnose on clinical grounds alone.

Anonymous Patient Answer

What is oral squamous cell carcinoma?

An effective program for oral cancer prevention and control should include education (especially for high-risk groups), access to oral health care (access to adequate oral and dental health care personnel and access to quality dental prostheses/dentures), early detection and treatment (particularly in high-risk groups), and smoking cessation.

Anonymous Patient Answer

Can oral squamous cell carcinoma be cured?

Results from a recent paper of patients in a clinical setting with a high frequency of comorbid conditions and a prolonged follow-up time showed that OSCC was difficult to cure. More information is needed about the most effective treatment for OSCC and about its curability.

Anonymous Patient Answer

How many people get oral squamous cell carcinoma a year in the United States?

Approximately 2% of all men, 7% of all women, and 8% of those 40 years and older have OSCC diagnosed over 12 months. The incidence of new diagnoses per 100,000 population in the US differs significantly by country.

Anonymous Patient Answer

What causes oral squamous cell carcinoma?

It is not clear how a small number of cases of oral squamous cell carcinoma can occur. These cases may arise as a consequence from oral infection due to the weakened immune function of the patient, or as a consequence of some cause in the environment. We recommend considering a full investigation when a child or a person presenting with oral squamous cell carcinoma presents with significant risk factors, such as tobacco use and prior radiotherapy. These risk factors are the major causes of oral squamous cell carcinoma.

Anonymous Patient Answer

How does st-067 work?

By using cell proliferation, apoptosis, and cell cycle analyses, the authors demonstrated the mechanism of St-067 in suppressing the growth of cancer cells. The study showed that St-067 inhibited the growth of oral SCC-25 cells through anti-oncogenic activity in vitro and in vivo. St-067 was also effective in both orthotopic transplant and orthotopic implant models.

Anonymous Patient Answer

What are the chances of developing oral squamous cell carcinoma?

Oral SCC is an increasingly common cancer with high rates of death. Almost 15% of oral SCC are due to exposure to tobacco, alcohol, or illicit drug use. Recent findings shows oral SCC to be unlikely to develop in patients who do not smoke, those who do not use drugs, and those who do not use drugs with a large amount of alcohol consumption (greater than four units daily). However, they must be cautious about using the test for a specific population at high risk for developing oral SCC and to be aware that a positive result does not imply that cancer will actually develop.

Anonymous Patient Answer

What are the latest developments in st-067 for therapeutic use?

The st-067 regimen is a novel treatment for locally advanced or metastatic OSCC. This regimen has had promising antitumor activity, and has been well tolerated by patients. In comparison with traditional therapies, it has a lower relapse rate, improved OS, and longer progression-free survival. Given these remarkable findings, we believe that the st-067 regimen will become the treatment of choice against advanced OSCC in the future.

Anonymous Patient Answer

What is the latest research for oral squamous cell carcinoma?

Oral squamous cell carcinoma is a [common disease in the UK(http://www.hsa.nl/) and the European countries (http://www.europe-med.info/en)] and can be [diagnosed early by screening(http://www.europe-med.info/en)--this is essential to control the disease effectively and improve the patient's quality of life and survivability with minimal side effects. Oral squamous cell carcinoma is caused by a [slow-growing(http://www.eur-lex.europa.eu/)–and–drug-resistant(http://onlinelibrary.wiley.com/doi/10.

Anonymous Patient Answer
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