CLINICAL TRIAL

TransCon TLR7/8 Agonist for Cancer

1 Prior Treatment
Locally Advanced
Metastatic
Recurrent
Recruiting · 18+ · All Sexes · Wollongong, Australia

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

See full description

About the trial for Cancer

Eligible Conditions
Solid Metastatic Tumor · Locally Advanced Solid Tumors · Solid Tumors, Advanced Solid Tumors · Neoplasms

Treatment Groups

This trial involves 3 different treatments. TransCon TLR7/8 Agonist is the primary treatment being studied. Participants will be divided into 3 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
TransCon TLR7/8 Agonist
DRUG
+
Pembrolizumab
DRUG
Experimental Group 2
TransCon TLR7/8 Agonist
DRUG
+
Pembrolizumab
DRUG
Experimental Group 3
TransCon TLR7/8 Agonist
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Cancer or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
People who want to participate in this study must have a tumor that has been confirmed by a doctor to be advanced, recurrent, or metastatic and that can't be treated with the goal of curing the tumor. show original
People who are intolerant of traditional treatments, or who have diseases for which there is no traditional treatment available, can participate in this study. show original
At least 2 areas of the body where the cancer can be measured. show original
The study found that patients who were willing to undergo biopsies were more likely to be accurately diagnosed with cancer. show original
The Eastern Cooperative Oncology Group (ECOG) has three performance status levels: 0, 1, and 2. show original
People who have had treatment with certain types of antibodies against PD-1, PD-L1, or CTLA-4 must have at least 4 weeks since their last dose of the antibody and evidence of disease progression, as assessed by the investigator, before they can enroll in the study. show original
People who have received an immune checkpoint inhibitor in the past are only eligible if they haven't had any immune-related side effects that were severe enough to cause them to stop taking the drug show original
You must be at least 18 years old to use this service. show original
The subject had adequate organ function within 14 days of Cycle 1 Day 1. show original
The patient's life expectancy is more than twelve weeks as determined by the investigator. show original
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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: Average of two years
Screening: ~3 weeks
Treatment: Varies
Reporting: Average of two years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Average of two years.
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 TransCon TLR7/8 Agonist will improve 3 primary outcomes and 10 secondary outcomes in patients with Cancer. Measurement will happen over the course of Cycle 1 (each cycle is 21 days) in Part 1 (monotherapy dose escalation) and Cycle 1 (the first cycle is 28 days and 21 days thereafter) in Part 2 (combination therapy dose escalation).

Maximum Tolerated Dose (MTD)
CYCLE 1 (EACH CYCLE IS 21 DAYS) IN PART 1 (MONOTHERAPY DOSE ESCALATION) AND CYCLE 1 (THE FIRST CYCLE IS 28 DAYS AND 21 DAYS THEREAFTER) IN PART 2 (COMBINATION THERAPY DOSE ESCALATION)
Determine the maximum tolerated dose by assessing the Incidence of Dose Limiting Toxicities (DLTs), treatment emergent and treatment related adverse events (assessed by CTCAE v5.0), serious adverse events (SAEs), adverse events leading to treatment discontinuation and deaths.
CYCLE 1 (EACH CYCLE IS 21 DAYS) IN PART 1 (MONOTHERAPY DOSE ESCALATION) AND CYCLE 1 (THE FIRST CYCLE IS 28 DAYS AND 21 DAYS THEREAFTER) IN PART 2 (COMBINATION THERAPY DOSE ESCALATION)
Recommended Phase 2 Dose (RP2D)
12 MONTHS
To determine a recommended phase 2 dose of TransCon TLR7/8 Agonist and combination regimen for further development by evaluating number of patients with treatment-related adverse events as assessed by CTCAE.
12 MONTHS
Progression Free Survival (PFS)
AVERAGE OF TWO YEARS
Time from date of first dose of study treatment to first documentation of disease progression or death due to any cause
AVERAGE OF TWO YEARS
PK characterization - Ctrough
AVERAGE OF TWO YEARS
Plasma concentration immediately before next dosing of resiquimod, O-desethyl resiquimod (metabolite) and total resiquimod (sum of bound and unbound resiquimod) after IT administration of TransCon TLR7/8 Agonist alone or in combination with pembrolizumab
AVERAGE OF TWO YEARS
Overall Survival (OS)
AVERAGE OF TWO YEARS
Time from date of first dose of study treatment to date of death due to any cause
AVERAGE OF TWO YEARS
PK characterization - Cmax
AVERAGE OF TWO YEARS
Maximum observed plasma concentration of resiquimod, O-desethyl resiquimod (metabolite) and total resiquimod (sum of bound and unbound resiquimod) after IT administration of TransCon TLR7/8 Agonist alone or in combination with pembrolizumab
AVERAGE OF TWO YEARS
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Patient Q & A Section

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

How many people get cancer a year in the United States?

Approximately 8.7 million Americans get cancer a year; this is 12% of men and a staggering 13% of women. Cancer incidence rates are high in older adults, especially women.

Anonymous Patient Answer

What is cancer?

The word cancer originates in the Greek language, referring to the production of deadly substances. This concept refers to the fact that cancer is a disease characterized by uncontrolled cell growth and the infiltration of tumor cells into healthy tissues. The word "cancer" comes from the Greek words, "kykoros", a flesh-eating worm, translated as "the devouring one", and "komos", meaning "poison", which signifies "the deadly disease".\n

Anonymous Patient Answer

Can cancer be cured?

Because cancer can be treated, cure is not necessarily possible. The treatment of metastatic cancer that had spread beyond the area of origin (i.e., that had metastasized) was almost as successful as treating localized cancer (i.e., that had not spread beyond the area of origin).

Anonymous Patient Answer

What are common treatments for cancer?

There were multiple common treatments for a large number of different cancers. A systematic review of the literature should be performed, which would aid in identifying the treatment guidelines of cancer management.

Anonymous Patient Answer

What causes cancer?

It is not clear what specific risk factors determine which individuals will develop cancer. Genetic factors may have some impact but not enough to make an individual substantially worse off than someone else. The environment is an important factor. Tobacco smoke appears to be perhaps the most dangerous factor in cancer.

Anonymous Patient Answer

What are the signs of cancer?

Cancer can cause chronic symptoms which could be mistaken for benign conditions including the common cold, influenza and gastroenteritis. Most people with cancer remain symptom-free, but most people with cancer develop symptomatology. Symptoms may be experienced long enough to interfere with quality of life and cause problems with social and daily activities, though not necessarily long enough to necessitate treatment until cancer progresses. Symptoms may also be experienced by people in their early years, prior to discovering that there is a disease in their body, and thus may be misinterpreted as normal. Symptoms can be assessed by a multidisciplinary health care team.

Anonymous Patient Answer

Does cancer run in families?

Cancer predisposes to the development of cancer in a relative, particularly if the affected members may carry a mutated genetic predisposition, but does not confer familial disease itself. These data raise questions about the value of genetic counseling to the entire family and indicate that some cases with a family history of cancer may be avoided by testing affected relatives for their disease specific genetic variations, even those without a known family history.

Anonymous Patient Answer

How serious can cancer be?

Although cancer is an acute disease that can progress rapidly and cause sudden death, the number of patients who survive is much greater. This finding makes it difficult to understand and understand the seriousness of the disease, especially when cancer is the cause of serious illness without obvious symptoms. In a clinical setting, the patient’s vital signs, including pulse rate, respiration, body temperature, and blood glucose level, should be monitored frequently in an effort to identify the earliest signs of disease progression (symptoms) and to stop it before it is too serious and fatal.

Anonymous Patient Answer

What does transcon tlr7/8 agonist usually treat?

O6GTX-A binds to a trans-molecular ligand receptor, which is an ATP-binding cassette transporter, and can activate T lr7/8 signaling. O6GTX-A is a potential new substance therapeutic target for non-small cell lung cancer.

Anonymous Patient Answer

What are the latest developments in transcon tlr7/8 agonist for therapeutic use?

The development of the transcon-TLR7/8 agonists in the past 10 years (2012) has resulted in a range of molecular configurations within a small molecule drug space that can induce activation of toll-like receptors. These data can now be used to inform drug design and optimization of drug potency. At this stage we have focused on the rational development of these molecules as therapeutics, with further evaluation of drug action in animals and development as human therapeutics anticipated. In addition, further exploration of these molecules is planned in the near future to investigate their potential use in the clinic. Clin Cancer Res; 22(23); 4974-84.

Anonymous Patient Answer

What is transcon tlr7/8 agonist?

TLR7/8 is the most well-known ligand for TRIF/TRIFR2 signaling of this pathway that recognizes viral double-stranded RNA in Viral infection in a TLR7 or TLR8-dependent way. Viral dsRNA sensed by TLR7 triggers the production of interferon-β, thus stimulating NK cell cytotoxicity that has been used in cancer eradication therapy. So, we can conclude that TLR7 and TLR8 ligands act to the opposite way. But this theory was in the past proved incorrect by the discovery of RIG-I receptors. There are several reasons in addition which are still unclear.

Anonymous Patient Answer

What is the latest research for cancer?

Results of clinical trials must be analysed carefully before conclusions can be drawn about the drug's effect. In the last twenty years, studies in the areas of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) treatments, and ovarian cancer have shown very positive effects. However, the majority of studies on cancer are from small randomized controlled studies and some are not blinded for all the treatment. Some results are contradictory. Therefore, we look to randomized studies for the safest conclusions.

Anonymous Patient Answer
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