CLINICAL TRIAL

AGEN1777 for Cancer, Advanced

Recruiting · 18+ · All Sexes · Houston, TX

This study is evaluating whether a drug called AGEN1777 is safe and tolerable in people with cancer.

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About the trial for Cancer, Advanced

Treatment Groups

This trial involves 2 different treatments. AGEN1777 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 and are in the first stage of evaluation with people.

Experimental Group 1
a PD-1 inhibitor
DRUG
+
AGEN1777
DRUG
Experimental Group 2
AGEN1777
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The patient has a measurable disease on baseline imaging, which is based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). show original
The patient must have a life expectancy of at least 3 months and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 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
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: From Day 1 of Cycle 1 (each cycle is 21 days [3 weeks]) until every 9 weeks (±7 days) for 12 months, and every 12 weeks (±7 days) thereafter up to 2 years or until progressive disease or unacceptable toxicity.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From Day 1 of Cycle 1 (each cycle is 21 days [3 weeks]) until every 9 weeks (±7 days) for 12 months, and every 12 weeks (±7 days) thereafter up to 2 years or until progressive disease or unacceptable toxicity..
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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 AGEN1777 will improve 2 primary outcomes and 7 secondary outcomes in patients with Cancer, Advanced. Measurement will happen over the course of Day 1 Up to End of Treatment (up to 2 years).

Maximum Observed Concentration at Steady State (Cmax-ss) of Serum AGEN1777 and a PD-1 inhibitor
DAY 1 UP TO END OF TREATMENT (UP TO 2 YEARS)
Serum a PD-1 inhibitor Anti-Drug Antibody (ADA) Determination
DAY 1 UP TO END OF TREATMENT (UP TO 2 YEARS)
Number of Participants with Dose-Limiting Toxicities (DLT) of AGEN1777 as a Single-Agent and in Combination with a PD-1 inhibitor
DAY 1 THROUGH DAY 21
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
UP TO 2 YEARS AND 90 DAYS
Serum AGEN1777 Anti-Drug Antibody (ADA) Determination
DAY 1 OF CYCLE 1 (CYCLE = 21 DAYS) THROUGH DAY 1 OF CYCLE 5. INCIDENCE OF ADA
Duration of Response (DOR) per RECIST v1.1 Based on Investigator's Assessment
FROM DAY 1 OF CYCLE 1 (EACH CYCLE IS 21 DAYS [3 WEEKS]) UNTIL EVERY 9 WEEKS (±7 DAYS) FOR 12 MONTHS, AND EVERY 12 WEEKS (±7 DAYS) THEREAFTER UP TO 2 YEARS OR UNTIL PROGRESSIVE DISEASE OR UNACCEPTABLE TOXICITY.
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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.

Can cancer, advanced be cured?

The concept of cancer and the experience of many patients with cancer are very optimistic as the cancer appears to have healed. The concept of cancer being cured does not fit the observed pattern of patient's feelings.

Anonymous Patient Answer

What is cancer, advanced?

Cancer is an uncontrolled abnormal rapid cell division in the cells of the body. It may form solid tumours or spread to other parts of the body. It can be detected in the early stage where it is not yet a serious issue of any serious problem as well as in the later stage in the most advanced form of cancer. Diagnosis and treatment are very important. The risk of cancer increases with age. Breast, prostate, colon and liver cancers are the most common.

Anonymous Patient Answer

What are common treatments for cancer, advanced?

Current treatments for cancer, advanced (stage 4) are often radical and are only palliative. Only a few non-invasive treatments are available to manage advanced cases. This article highlights the most common and effective treatments for cancer, advanced.

Anonymous Patient Answer

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

Approximately 18,900 new cases of cancer, advanced a year will be diagnosed under the age and/or gender of most U.S. citizens aged 20 years or older (21,200 for women; 19,400 for men): 19% will die from cancer. The gender gap increases with age, with men being slightly more likely than women to go under the age of 20 years (2,700 persons for men; 2,200 persons for women) go under age 70 (28,000 for men; 24,000 for women); and are more likely to be under age 20 (26,400 for men; 25,300 for women) than to be over 70 (30,700 for men; 22,600 for women).

Anonymous Patient Answer

What are the signs of cancer, advanced?

Symptoms often manifest with no physical examinations, are non-specific, and are suggestive of a number of other conditions. These symptoms may delay detection of cancer, as it is a disease characterized by symptom-free intervals of several years. There are a number of syndromes that may manifest as symptoms consistent with cancer, most of which require differential diagnosis, which involves the combination of signs and symptoms as well as the individual patient's medical history, to identify the most likely diagnosis.

Anonymous Patient Answer

What causes cancer, advanced?

Cancer is largely attributed to genetic, developmental, and environmental influences that lead to progression along a complex multistep signaling pathway. Many of these factors are also implicated in the development of schizophrenia. The genetic variations of these disorders that cause significant morbidity are significant.

Anonymous Patient Answer

Does cancer, advanced run in families?

Our cross-sectional study in a population-based family-based study demonstrates that cancer in the family is a common occurrence. However, the familial cancer risk is not statistically significant for any type of cancer.

Anonymous Patient Answer

What is agen1777?

It is clear that some patients with advanced melanoma will develop brain metastatic disease, and several factors can impact prognosis and survival including age, BRAF/NRAS status, number, stage of metastatic disease, type of primary melanoma, gender, and the presence of extracranial metastases. The exact pathways for invasiveness of the primary tumor and metastatic dissemination of the tumor are not known. As the metastatic disease moves from the brain to the periphery, the likelihood of being eligible for intracranial-directed chemotherapy, radiotherapy, or surgery will decrease.

Anonymous Patient Answer

What are the common side effects of agen1777?

There are no commonly reported and dose-dependent side effects from using Agen1777. However, since more than 100 of the 1450 patients are women, it might be prudent to exclude the use of this product during pregnancy, and possibly breastfeeding.

Anonymous Patient Answer

Is agen1777 typically used in combination with any other treatments?

The combination of AGen1777 with the targeted therapy of chemotherapy may be promising for treatment of cancer stem cells and for targeting the CSC fraction.

Anonymous Patient Answer

Have there been other clinical trials involving agen1777?

This is the first reported trial of agen1777 in patients having undergone surgery. Results from a recent paper indicate anti-cancer and anti-lympho-proliferative actions, and an early, selective, and sustained inhibition of growth in metastatic melanoma lesions. Further studies are needed in order to identify possible clinical application of this peptide in a variety of cancer types.

Anonymous Patient Answer

How does agen1777 work?

In a recent study, findings suggest that Agen1777 works through the PI3K/AKT pathway that is downregulated in HCC cells compared to normal livers and thus induces apoptosis in HCC cells.

Anonymous Patient Answer
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