MT-6402 for Oral Squamous Cell Carcinoma

Phase-Based Estimates
1
Effectiveness
1
Safety
Tennessee Oncology, PLLC, Nashville, TN
Oral Squamous Cell Carcinoma+2 More
MT-6402 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Oral Squamous Cell Carcinoma

Study Summary

This study is evaluating whether a new drug may help treat cancer.

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Eligible Conditions

  • Oral Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of Head and Neck
  • Solid Tumors, Advanced Solid Tumors
  • Non-small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether MT-6402 will improve 4 primary outcomes, 3 secondary outcomes, and 8 other outcomes in patients with Oral Squamous Cell Carcinoma. Measurement will happen over the course of 28 days (Part 1).

28 days (Part 1)
Evaluate the safety of MT-6402 in subjects with advanced cancer (solid tumors) and to estimate the maximum tolerated dose (MTD)
Evaluate the tolerability of MT-6402 in subjects with advanced cancer (solid tumors) and to estimate the maximum tolerated dose (MTD)
28 days (Part 2)
Confirm the recommended Phase 2 dose (RP2D)
Day 28
Evaluate the immunogenicity of MT-6402 in subjects with advanced cancer
Day 28
Explore pharmacodynamic effect of cytomegalovirus (CMV) antigen presentation
Day 28
Correlate pharmacodynamic effect of cytomegalovirus (CMV) antigen presentation with tumor response
Year 2
Evaluate efficacy of MT-6402 in subjects with advanced cancer by ORR with RECIST 1.1
Year 2
Evaluate efficacy of MT-6402 in subjects with advanced cancer by objective response rate (ORR) with RECIST 1.1
Explore efficacy of MT-6402 in subjects with advanced cancer by using ORR
Year 2
Assess additional efficacy parameters
Assess quality of life with MT-6402 treatment
Characterize the PK profile of MT-6402 in subjects with advanced cancer
Correlate the pharmacodynamic markers of cancer under study with tumor response to MT-6402 in subjects with advanced cancer
Explore immune response to MT-6402 treatment
If warranted, evaluate the exposure-response relationship for MT-6402 via Pharmacokinetics (PK) parameters

Trial Safety

Safety Estimate

1 of 3

Trial Design

4 Treatment Groups

No Control Group
Other relapsed/refractory PD-L1 positive solid tumors

This trial requires 138 total participants across 4 different treatment groups

This trial involves 4 different treatments. MT-6402 is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Other relapsed/refractory PD-L1 positive solid tumors
Drug
Subjects with any other relapsed or refractory PD-L1 positive solid tumor who received PD-1/PD-L1 treatment.
PD-L1 Positive SCCHN
Drug
Subjects with PD-L1 Positive Squamous Cell Carcinoma of the head and neck (SCCHN), refractory to or ineligible for platinum-based therapy, who received prior PD-1/PD-L1 treatment
PD-L1 Positive NSCLC
Drug
Subjects with PD-L1 Positive Lung Carcinoma (NSCLC) who received prior PD-1/PD-L1 treatment
PD-L1 positive advanced cancer
Drug
Subjects with PD-L1 positive advanced cancer (solid tumors)

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years (parts 1 and 2)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 years (parts 1 and 2) for reporting.

Closest Location

Tennessee Oncology, PLLC - Nashville, TN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Oral Squamous Cell Carcinoma or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The subject must have a disease that can be evaluated or measured. show original
To be eligible for this study, subjects must: a) be at least 18 years old b) have histologically confirmed, unresectable, locally advanced or metastatic PD-L1-expressing solid cancer (defined below) c) not be amenable to standard treatment, or standard treatment is not available, or in the Investigator's opinion the standard treatment would not be in the subject's best interest d) have PD-L1 expression assessed at screening by the study's central laboratory, using VENTANA SP263 PD-L1 assay on a tissue from a site of metastatic disease (if possible) show original
The subject must be at least 18 years old, have histologically confirmed, unresectable, locally advanced, or metastatic PD-L1 expressing solid cancer not amenable to standard treatment, or standard treatment is not available, or in the Investigator's opinion the standard treatment would not be in the subject's best interest show original
Part A
This arm is for subjects with histologically confirmed recurrent or metastatic SCCHN (oral cavity, oropharynx, hypopharynx, or larynx) that is not amenable to standard treatment, or the standard treatment is not available, or in the Investigator's opinion the standard treatment would not be in the subject's best interest show original
The subject has a type of lung cancer that keeps coming back or has spread to other parts of the body, and the standard treatments haven't worked or aren't available show original
Part B
Subjects with any type of PD-L1 positive solid tumor that has relapsed or not responded to standard treatment, or for which standard treatment is not available, may be enrolled in this study show original
The subject must have at least one measurable tumor lesion according to the RECIST 1.1 guidelines. show original
Both A and B are correct show original

Patient Q&A Section

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

What are common treatments for oral squamous cell carcinoma?

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Oral squamous cell carcinoma can be diagnosed at any age, which makes it a lethal disease. However, patients do best when symptoms are first identified at an early stage. Oral squamous cell carcinoma is a common cancer that is treated with surgery, chemotherapy, or radiation therapy. Prognosis is determined by the stage of the cancer as well as by the treatment given. Patients may benefit from an alternative to conventional treatment in select cases.

Unverified Answer

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

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Approximately 43,000 people will be diagnosed with oral SCC in the United States in 2002, a 20% increase over the previous year. The incidence of SCC of the vulva has increased at a comparable rate. These data highlight the need for cancer prevention and control programs.

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Can oral squamous cell carcinoma be cured?

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Oral SCC has a cure rate of less than 1% if treated early. Patients diagnosed with early stage and well-differentiated oral SCC have an excellent chance of cure. Ondays, the cure rate falls to less than 35%, and the percentage of well-differentiated oral SCC that may be cured is around 25%. In the case of advanced oral SCC, cure at staging is very low and treatment is mostly palliative.

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What are the signs of oral squamous cell carcinoma?

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In the clinical setting of head and neck surgeon performing treatment of oral squamous cell carcinoma there are several signs that should alert the physician to the possibility of a malignant tumour. It is the absence of pain and redness on the palpation of a hard tumour that should be taken into account as these signs may be elicited by an underlying dental pathogenic process. It should be borne in mind that oral squamous cell carcinoma may be present solely on investigations, ie, dental radiographs, endo-labial videography, panendoscopy. Other imaging studies (for example CT scan, ultrasound, PET and MRI) are not routinely performed for head and neck tumours.

Unverified Answer

What is oral squamous cell carcinoma?

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The term [head and neck cancer](https://www.withpower.com/clinical-trials/head-and-neck-cancer) is often used to refer to oropharyngeal cancer. Oral squamous cell carcinoma (OSCC) often includes the tongue, oropharynx and larynx and is the sixth most common cancer in the UK. This article covers head and neck and oral cancer. The word oropharongeal is a misnomer. The head and neck area is not confined just to the oral cavity and includes the parotid gland, the thyroid and salivary gland, the larynx and oesophagus, the pharynx, nasal cavity and paranasal sinuses and the upper respiratory tract.

Unverified Answer

What causes oral squamous cell carcinoma?

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The main risk factors for OSCC included smoking and a high alcohol consumption. The study supports an increased risk of oral cancer with heavy smoking and strengthens that there is a synergistic effect of heavy drinking and smoking on the development of OSCC.

Unverified Answer

What is the primary cause of oral squamous cell carcinoma?

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Although the role of smoking is well documented, only a small number of people who smoke are diagnosed with OSCC. Further studies should concentrate on examining factors that confer protection against cigarette smoking in OSCC.

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Is mt-6402 safe for people?

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In a recent study, findings provides the safety of treatments given to patients ≥ 30 years old when performed < 7 days following the chemotherapy.

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What are the latest developments in mt-6402 for therapeutic use?

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New developments in mt-6402, particularly concerning its application of chemotherapy through its ability to increase apoptosis in cancer cells, may permit more patients to benefit from this treatment in a clinical setting.

Unverified Answer

Does oral squamous cell carcinoma run in families?

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In conclusion, our findings indicate that neither genetic nor environmental factors are the sole cause of OSCC. Therefore, a complex interaction of both genetic-environmental factors is required for the development of OSCC. Since OSCC is associated with a familial occurrence, these findings warrant future studies in the families studied to identify familial susceptibility or protection as a contributing factor. Genetic markers of familial transmission may help to predict inherited susceptibility to develop oral potentially malign tumors.

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How serious can oral squamous cell carcinoma be?

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The prognostic factors of the cancer and the extent of surgical resection were the major indicators for predicting the prognosis of OSCC. These two factors should be taken into consideration to make the treatment plans.

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Who should consider clinical trials for oral squamous cell carcinoma?

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The majority of those who are eligible for a clinical trial do not complete the study. Reasons for non-completion include a change of medical management and deterioration of condition, with referral to specialists or palliative care as the last choice.

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See if you qualify for this trial
Get access to this novel treatment for Oral Squamous Cell Carcinoma by sharing your contact details with the study coordinator.