What side effects are associated with this type of intervention?

Common treatments for Head and Neck Squamous Cell Carcinoma (HNSCC) include radiation therapy (RT), chemoradiation, and systemic therapies. Known side effects of these treatments include mucositis, dysphagia, and the need for tube feeding, particularly with higher doses of RT. Chemoradiation can lead to additional toxicities such as ulceration, soft tissue necrosis, fibrosis, and fistula formation. Systemic therapies, including chemotherapy and targeted agents like cetuximab, can cause severe skin reactions, hypomagnesemia, and infusion-related reactions. These treatments can also result in long-term toxicities affecting quality of life, such as xerostomia and pain.

What prior FDA approvals exist?

The FDA has approved several treatments for Head and Neck Squamous Cell Carcinoma (HNSCC), including cetuximab, an EGFR-targeting monoclonal antibody used with radiation therapy and chemotherapy, and PD-1 inhibitors such as nivolumab and pembrolizumab for patients previously treated with platinum-based chemotherapy. These treatments focus on targeted and immunotherapy approaches, which are relevant to the study of new anti-cancer agents like TT-10.

What other types of research exist?

Promising novel alternatives to TT-10 for HNSCC patients include: <ol> <li>Pembrolizumab (Keytruda) - demonstrated an overall response rate of 12% with median PFS and OS of 4 and 13 months, respectively, in recurrent/metastatic settings.</li> <li></li> </ol> Nivolumab - ongoing trials are evaluating its efficacy in metastatic salivary gland tumors. 3. Sorafenib and Axitinib - TKIs targeting VEGF with clinical response rates of 16% and 9%, respectively. 4. Avasopasem Manganese (GC4419) - reduced severe oral mucositis in patients receiving concurrent cisplatin and radiation therapy, with ongoing evaluation of tumor outcomes.

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TT-10 for Advanced Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Portage Biotech

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have adequate hepatic function based on specific criteria

Participants must have adequate renal function based on specific criteria

Must not have

History of peptic ulcer and/or gastrointestinal bleed within the past 6 months prior to Screening

Female participants who are pregnant or breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new oral drug, TT-10, for safety and effectiveness in people with severe cancers that did not improve with usual treatments. The goal is to determine a safe dosage and see if it can help control tumor growth.

Who is the study for?

Adults with advanced solid tumors like oral, head and neck, kidney, prostate or lung cancer who've not responded to standard treatments can join. They must have a life expectancy over 3 months, good blood and organ function, and be able to consent. Some need accessible tumors for biopsies.

What is being tested?

The trial is testing TT-10's safety when taken orally by patients with certain advanced cancers. It aims to find the highest dose patients can tolerate without severe side effects (MTD) or the suggested dose for future Phase 2 trials (RP2D).

What are the potential side effects?

Specific side effects of TT-10 are not listed but generally may include typical reactions to cancer medications such as nausea, fatigue, risk of infection due to low blood counts, liver issues or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver is functioning well.

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My kidney function is within normal ranges.

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I am 18 years old or older.

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My cancer is confirmed and advanced.

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My advanced lung cancer has not responded to or is not suitable for standard treatments.

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I have kidney cancer that has spread and standard treatments haven't worked or I can't receive them.

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I have RCC, CRPC, or NSCLC and cannot receive standard treatments.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a peptic ulcer or gastrointestinal bleed in the last 6 months.

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I am not pregnant or breastfeeding.

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I need medication to suppress my immune system.

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I do not have any active cancer except for non-dangerous skin cancer, early-stage cervical or prostate cancer.

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I do not have any severe uncontrolled health conditions.

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I have had lung conditions that needed steroid treatment.

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I do not have any ongoing serious infections.

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I have not had major surgery in the last 4 weeks.

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My cancer has spread to my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Define the maximum tolerated dose (MTD) or phase 2 recommended dose of TT-10 during the dose escalation phase

Expansion cohort primary objective - safety

Number of subjects with Dose Limiting Toxicities (DLTs) of TT-10 during the dose escalation phase

Secondary study objectives

Area under the serum concentration versus time curve (AUC) of TT-10

Duration of Response (DoR)

Half-life of TT-10

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Multiple Ascending DoseExperimental Treatment1 Intervention

3+3 Dose escalation until MTD and/or R2PD of TT-10 is determined

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Head and Neck Squamous Cell Carcinoma (HNSCC) include surgery, radiation therapy, chemotherapy, and targeted molecular therapies. Surgery involves physically removing the tumor, which is crucial for localized disease. Radiation therapy uses high-energy rays to kill cancer cells and shrink tumors, often used when surgery is not feasible. Chemotherapy employs drugs to destroy cancer cells or stop their growth, and is frequently combined with radiation for enhanced efficacy. Targeted molecular therapies, such as those being investigated in trials like TT-10, aim to interfere with specific molecules involved in cancer growth and progression, offering a more personalized treatment approach. These treatments are vital for HNSCC patients as they provide multiple strategies to manage and potentially cure the disease, depending on its stage and location.