VB10.NEO for Solid Tumors, Adult

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The Regents of the University of California, San Francisco, CA
Solid Tumors, Adult+1 More
VB10.NEO - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a vaccine can be safely given with an anti-PD-1 antibody.

See full description

Eligible Conditions

  • Solid Tumors, Adult

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Solid Tumors, Adult

Study Objectives

This trial is evaluating whether VB10.NEO will improve 3 primary outcomes, 7 secondary outcomes, and 1 other outcome in patients with Solid Tumors, Adult. Measurement will happen over the course of From baseline and up to 25 months.

Month 25
Assessment of the antigen-specific immune response elicited by VB10.NEO administered in combination with atezolizumab
Characterize the pharmacokinetic of atezolizumab when administered in combination with VB10.NEO.
Evaluate the immune response to atezolizumab when administered in combination with VB10.NEO
Month 27
Changes from baseline in clinical laboratory parameters
Changes from baseline in vital signs
Duration of response (DOR)
Incidence and severity of adverse events (AEs)
Objective response rate (ORR)
Overall survival (OS)
Progression free survival (PFS)
Year 2
Dose finding objective

Trial Safety

Safety Progress

1 of 3

Other trials for Solid Tumors, Adult

Trial Design

2 Treatment Groups

VB10.NEO 6 mg in combination with Atezolizumab 1200 mg
1 of 2
VB10.NEO 3 mg in combination with Atezolizumab 1200 mg
1 of 2
Experimental Treatment

This trial requires 40 total participants across 2 different treatment groups

This trial involves 2 different treatments. VB10.NEO 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.

VB10.NEO 6 mg in combination with Atezolizumab 1200 mg
Biological
VB10.NEO 6 mg will be administered by IM injection for an induction course Q3W (4 doses) followed by maintenance doses Q6W (6 doses) and Q12W (5 doses). Atezolizumab 1200 mg will be administered by intravenous (IV) infusion on Day 1 of 21 day cycles.
VB10.NEO 3 mg in combination with Atezolizumab 1200 mg
Biological
VB10.NEO 3 mg will be administered by IM injection for an induction course Q3W (4 doses) followed by maintenance doses Q6W (6 doses) and Q12W (5 doses). Atezolizumab 1200 mg will be administered by intravenous (IV) infusion on Day 1 of 21 day cycles.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 2 years.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through study completion, an average of 2 years. for reporting.

Closest Location

The Regents of the University of California - San Francisco, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Solid Tumors, Adult or the other condition 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:
You must be at least 18 years old in order to sign the Informed Consent Form. show original
A patient with a cancer who has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 is usually able to carry out all usual activities. show original
The ANC level would need to be ≥1.5×109/L (1500/µL) without granulocyte colony-stimulating factor support. show original
A lymphocyte count of ≥0.5 × 109/L (500/µL) is suggestive of lymphoma. show original
in the previous 24 hours The person has a platelet count of at least 100,000 per microliter and did not need a transfusion within the previous 24 hours. show original
The study will enrol patients with the following tumor types: melanoma, NSCLC, RCC, UC, HNSCC, TNBC, gastric/GEJ cancer, cervical, anal, or MSI-high tumors show original
Signed Informed Consent Form
This means that a person's life expectancy is six months or longer. show original
The ability to comply with the trial protocol is essential for the success of a clinical trial show original
in men and ≥80 g/L (8 g/dL) in women indicates anemia show original

Patient Q&A Section

Can cancer be cured?

"Can cancer be cured? answer: The possibility of cure for a wide range of solid tumours has not been proven. The use of surgery alone is often inadequate due to the development of metastatic disease that can be treated with chemotherapy or radiotherapy. The ability of cancer to form new tumours despite treatment is also a difficult problem in cancer surgery, and warrants future effort to find effective approaches to preventing this problem." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cancer?

"Few individuals diagnosed with cancer receive treatment solely based on medical criteria. A minority of patients in this study received no treatments or therapies. In the absence of clinical trials to define optimal treatments, medical practitioners sometimes decide more on clinical judgment than on objective criteria. Future interventions to increase the use of effective therapies should focus on reducing unnecessary diagnostic tests and tests of nonspecific clinical value, improving cancer education, promoting optimal cancer screening, and identifying patients most likely to benefit from adjuvant therapies." - Anonymous Online Contributor

Unverified Answer

What are the signs of cancer?

"Cancer typically presents with a sudden painless enlargement of the size and/or the girth of one or both sides of the body, and sometimes, the head or neck, due to lymphocytic infiltration and/or metastasis.\n" - Anonymous Online Contributor

Unverified Answer

What is cancer?

"This definition of cancer is the most widely used in the field. It is useful when it is applied to specific and individual cancers. The general consensus is that the word "cancer" should only be substituted when the medical term is available, or where no better term exists. In the latter case, and in clinical practice, the word should be restricted to synonymous expressions when a generic term is used, as in 'disease of the body organs', 'disease of the respiratory tract', or 'disease of the eye'." - Anonymous Online Contributor

Unverified Answer

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

"Approximately 6.6 million people (5.5% of the population) are diagnosed with cancer a year in the United States. There are roughly 240,000 new cancer diagnoses per year. The burden of non-melanoma skin cancer is higher than for melanoma. There are about 80,000 new cases of head and neck cancer, 50,000 new cases of breast cancer, 45,000 new cases of colorectal cancer and 38,000 new cases of cervical cancer. Cancer incidence, stage of presentation and survival are worse for people with limited or unspecified limitation in daily functioning. Cancer mortality for the total population is falling, but worse in non-Hispanic black men aged 85 or older (23." - Anonymous Online Contributor

Unverified Answer

What causes cancer?

"Approximately 17% of the world's population dies of malignant disease of the breast, colon, prostate, lung or kidney. Most cancers can be diagnosed only after many years. What causes cancer? A number of factors contribute to the development of cancer. This may be through inherited or acquired factors, such as viruses, bacteria, DNA damage, toxins, genetic and environmental factors. A common link or link in causation may exist between cancer and viruses, and, to a lesser extent, some environmental factors. The mechanism of causation for cancer is highly complex and requires a multidisciplinary approach to be understood. It is important to examine both current and historic information on the subject to gain a wider understanding and hopefully improve patient management." - Anonymous Online Contributor

Unverified Answer

What is vb10.neo?

"The expression of the Vb10 gene by the host is upregulated by HBV to enhance the replication of HBV on the hepatocyte. HBV may also induce the production of a new and unique small RNA molecule named vb10.neo. The vb10.neo siRNA inhibits expression of Vb10 gene to a great extent and reduces the hepatitis B virus DNA in vitro." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of cancer?

"The association between lifestyle risk factors and the development of cancers is well-known among the general population. More recently, genetic predisposition is added to the list of factors that may cause cancer. As our understanding of the aetiology expands, it is possible that in some circumstances, cancer can be caused by a complex mixture of genetic and environmental risk factors. Therefore, how the cause of cancer affects the phenotype (i.e. how it manifests itself and where it spreads) is a crucial aspect of the emerging research on cancer." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets cancer?

"In the Western world, the average age of people diagnosed with cancer is aged 60 years, with a range of 49 to 69 years for males and 51 and 69 years for females. It does seem to reflect the typical age at which cancer is normally diagnosed. The overall age at which cancer is diagnosed appears to be rising in the UK." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of vb10.neo?

"Data from a recent study suggest that the effect of VVb10.neo is related to the inhibition of collagen synthesis, which is the main process of tumor growth." - Anonymous Online Contributor

Unverified Answer

How serious can cancer be?

"Every cancer has some very serious risks. The most serious risks are that of the underlying disease that starts the cancer in the first place (especially if not treatable), that the cancer spreads around the body, and that, if there's a cure or even a good treatment, it may become more dangerous as many of the side effects of the treatment may become apparent (which is known as a drug effect). However, many cancer patients cope with all these factors happily and get on with their lives without the need for serious thinking about the risks. Many don't need to." - Anonymous Online Contributor

Unverified Answer

Does cancer run in families?

"Cancer family history can be identified in a family even when many of the members do not have diagnosed disease. This finding suggests that an emphasis should be placed on implementing family education programs for those affected by cancer and early identification of family members with a family history of cancer will help minimize the occurrence of illness in future generations. This is the first study to show that cancer cases in a given population are familial" - Anonymous Online Contributor

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