CLINICAL TRIAL

VIP152 (BAY 1251152) for Cancer

Locally Advanced
Refractory
Recruiting · 18+ · All Sexes · Silver Spring, MD

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

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About the trial for Cancer

Treatment Groups

This trial involves 4 different treatments. VIP152 (BAY 1251152) 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.

Experimental Group 1
VIP152 (BAY 1251152)
DRUG
Experimental Group 2
Keytruda
DRUG
+
VIP152 (BAY 1251152) 15 mg
DRUG
Experimental Group 3
VIP152 (BAY 1251152) 30 mg
DRUG
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Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Adequate bone marrow, liver, and renal functions
This text refers to the Eastern Cooperative Oncology Group's performance status system, which rates people from 0 (fully active) to 2 (fully disabled). show original
In addition to Part 3 and Part 4, there is also a Part 3 (US Only) and a Part 4 (US Only). show original
The patient must be eligible to use pembrolizumab according to the USPI. show original
Male or female patients aged >/=18 years
Part 2 (Global), Part 3 (US Only), and Part 4 (US Only)
, as determined by a Clinical Laboratory Improvement Amendments (CLIA)- approved assay, will be eligible for the study 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: Cycle1 / Day 1 (C1D1), C1D2,C1D3, C1D4, C1D8C1D15, C1D16,C1D17,C1D18,C2D1
Screening: ~3 weeks
Treatment: Varies
Reporting: Cycle1 / Day 1 (C1D1), C1D2,C1D3, C1D4, C1D8C1D15, C1D16,C1D17,C1D18,C2D1
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Cycle1 / Day 1 (C1D1), C1D2,C1D3, C1D4, C1D8C1D15, C1D16,C1D17,C1D18,C2D1.
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 VIP152 (BAY 1251152) will improve 12 primary outcomes and 1 secondary outcome in patients with Cancer. Measurement will happen over the course of Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 21 days.

Incidence of DLT (Dose limit toxicity) of VIP152 (BAY1251152)
CYCLE 1 DAY 1 THROUGH CYCLE 2 DAY 1, WHERE EACH CYCLE IS UP TO 21 DAYS
CYCLE 1 DAY 1 THROUGH CYCLE 2 DAY 1, WHERE EACH CYCLE IS UP TO 21 DAYS
Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP152 (BAY1251152)
CYCLE 1 DAY 1 THROUGH CYCLE 2 DAY 1, WHERE EACH CYCLE IS UP TO 21 DAYS
CYCLE 1 DAY 1 THROUGH CYCLE 2 DAY 1, WHERE EACH CYCLE IS UP TO 21 DAYS
AUC from time 0 to the last data point > Lower limit of quantitation (LLOQ) [AUC(0-tlast)] of VIP152 (BAY1251152)
CYCLE 1 DAY 1 THROUGH CYCLE 2 DAY 1, WHERE EACH CYCLE IS UP TO 21 DAYS
CYCLE 1 DAY 1 THROUGH CYCLE 2 DAY 1, WHERE EACH CYCLE IS UP TO 21 DAYS
Recommended phase 2 dose (RP2D) of VIP152 (BAY 1251152)
CYCLE 1 DAY 1 THROUGH CYCLE 2 DAY 1, WHERE EACH CYCLE IS UP TO 21 DAYS
CYCLE 1 DAY 1 THROUGH CYCLE 2 DAY 1, WHERE EACH CYCLE IS UP TO 21 DAYS
Recommended phase 2 dose (RP2D) of VIP152 (BAY 1251152) in combination with Keytruda® (pembrolizumab)
CYCLE 1 DAY 1 THROUGH CYCLE 2 DAY 1, WHERE EACH CYCLE IS UP TO 21 DAYS
CYCLE 1 DAY 1 THROUGH CYCLE 2 DAY 1, WHERE EACH CYCLE IS UP TO 21 DAYS
Maximum observed drug concentration in measured matrix after multiple dose administration during a dosage interval (Cmax,md) of VIP152 (BAY1251152)
CYCLE 1 DAY 1 THROUGH CYCLE 2 DAY 1, WHERE EACH CYCLE IS UP TO 21 DAYS
CYCLE 1 DAY 1 THROUGH CYCLE 2 DAY 1, WHERE EACH CYCLE IS UP TO 21 DAYS
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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 be cured?

When an early cancer has not metastasized or invaded nearby tissues, it can be cured with surgery, radiation therapy, or radiochemotherapy, with a five year survival rate estimated between 36 and 71%. A randomized controlled trial in the future would be required to determine the true cure rate for prostate cancer.

Anonymous Patient Answer

What are common treatments for cancer?

In contrast with other types of cancer, there are limited common therapies. Most cancers are managed with medical treatment, either by surgery, chemotherapy, radiation therapy, or combinations of these. Common treatments include surgery, radiotherapy, palliative care, and chemotherapy for both Hodgkin's and non-Hodgkin's lymphomas, chemo-, and radiation therapy used for treatment of solid tumors, and palliative care.

Anonymous Patient Answer

What are the signs of cancer?

The early signs and symptoms can be divided into three types: early or acute symptoms of the disease which tend to disappear or diminish over time, chronic or latent symptoms which tend to last even longer, and combinations of the former two. The signs and symptoms depend on the type of cancer in question. For example, some common causes of chronic or latent diseases tend to have acute symptoms that tend to disappear very quickly while others tend to have signs that persist. On a practical level, a list of the possible early signs and symptoms of cancer may be an important way of recognizing and dealing with the disease and seeking appropriate medical attention.

Anonymous Patient Answer

What causes cancer?

Different types of cancer may have different causes, including genetics and lifestyle. There is also some evidence that ultraviolet light (UV) may increase the risk of developing cancers. Exposure to ionising radiation may modify our genetic makeup, making some people more likely to develop cancer as a result.\n

Anonymous Patient Answer

What is cancer?

Cancer was probably the cause of death of 1 in 24 participants. Most participants in this study did not feel that their lifestyles, diet or general health were affected by cancer.

Anonymous Patient Answer

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

The current U.S. population has about 6 billion people in total. Taking life (deaths) to account for, the number of cancers diagnosed a year in the U.S. is about 4 million for males and about 3 million for females a year. This means that more than 1.7 million new cancers were diagnosed per year among U.S. citizens. (This would be about 1 third more cancers per year if life were taken into account.

Anonymous Patient Answer

Has vip152 (bay 1251152) proven to be more effective than a placebo?

This trial supports results obtained in previous clinical trials using Vip152, suggesting that a more efficient dose regimen may be required for it to exert its anti-cancer effects. Vip152 is an effective and well tolerated drug which may have therapeutic value against hepatocellular carcinoma. More studies are required to determine the optimum and most effective dose schedule for Vip152 to be used.

Anonymous Patient Answer

What are the common side effects of vip152 (bay 1251152)?

The common side effects of Vip152 are dizziness, fatigue, abdominal pain, constipation and diarrhea. These side effects are very common in patients taking Vip152. There were also statistically significant differences between groups. Vip152 was the only statistically significant variable impacting the quality of life. No dose dependency was found. All doses studied did not affect hemoglobin levels.

Anonymous Patient Answer

What does vip152 (bay 1251152) usually treat?

Vip152 is an effective and convenient treatment for a range of disease categories not addressed by currently available treatment regimens - so it is likely to yield improvements in outcomes and reductions of side effects for an even wider range of people with cancer.

Anonymous Patient Answer

How serious can cancer be?

The risk that a cancer is metastatic is as great as that of other causes of death from cancer. For instance, an average of 28 percent of women and 17 percent of men who die from cancer do so after 5 years, but only 15 percent of all women and 9 percent of all men die from other causes of death within this time. However, an individual’s risk of dying from cancer is more dependent on cancer than any other risk factor. Cancer is the single most serious cause of death in the United States.

Anonymous Patient Answer

What is vip152 (bay 1251152)?

The current study establishes that vip152 is a novel anti-CXCR4 monoclonal antibody which, when co-administered with gemcitabine, significantly enhanced the efficacy of drug therapy in pancreatic cancer. Results from a recent clinical trial demonstrate for the first time, in vivo, and support potential translational study of vip152 in pancreatic cancers.

Anonymous Patient Answer

Does cancer run in families?

Results from a recent clinical trial do not reveal a strong evidence in favor of the hereditary factors of breast cancer, colorectal cancer, ovarian cancer and prostate cancer. An association between breast cancer and breast cancer in first degree relatives was observed. Thus, there are also familial factors that may contribute to an increased risk of breast cancer in individuals with first degree relatives living with breast cancer.

Anonymous Patient Answer
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