BDB001 for Tumors, Solid

Phase-Based Estimates
1
Effectiveness
2
Safety
Dana-Farber/Mass General Hospital, Boston, MA
BDB001 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Tumors, Solid

Study Summary

This study is evaluating whether a drug may help treat solid tumors.

See full description

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether BDB001 will improve 1 primary outcome and 8 secondary outcomes in patients with Tumors, Solid. Measurement will happen over the course of 3 months through approximately 2 years.

Year 2
Efficacy as measured by Progression-Free Survival (PFS)
Efficacy as measured by RECIST 1.1 (ORR, DCR, PFS, and DoR)
Evaluate Duration of Response (DoR)
Year 5
Evaluate Biomarkers
Year 2
Efficacy as measured by Disease Control Rate
Efficacy as measured by Objective Response Rate
Efficacy as measured by Overall Survival (OS)
Efficacy as measured by Time-to-Treatment Failure (TTF)
Safety and Tolerability of BDB001

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

2 Treatment Groups

Control
BDB001

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. BDB001 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

BDB001
Drug
BDB001 will be administered intravenously as monotherapy in subjects with histologically-confirmed unresectable or metastatic solid tumors that have progressed on anti-PD-1 or anti-PD-L1 mAb treatment either as monotherapy or in combination with other therapies.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximately up to 1.5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly approximately up to 1.5 years for reporting.

Closest Location

Dana-Farber/Mass General Hospital - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The patient has a lesion that is available for biopsy, and has given consent to allow pre-treatment tumor biopsy. show original
Certain types of cancer are allowed, such as skin cancer, head and neck cancer, melanoma, Merkel cell carcinoma, NSCLC, renal cell carcinoma, and urothelial carcinoma, but other tumor types will be allowed at the discretion of the sponsor. show original
The tumor progressed on the most recent line of treatment with an anti-PD-1 or anti-PD-L1 monoclonal antibody. show original
Eastern Cooperative Oncology Group (ECOG) score of 0 - 2
At least 1 lesion with a diameter ≥5 mm at baseline At least 1 lesion with a diameter ≥10 mm at baseline At least one lesion with a diameter of at least 5 millimeters at baseline show original

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 tumors, solid a year in the United States?

Add answer

Tumor, solid cancer cases exceed 1 million per year in the U.S. The majority of these tumors occur in the upper and mid parts of the body.\n

Unverified Answer

What are the signs of tumors, solid?

Add answer

There are signs and symptoms of solid tumors in patients such as: pain, weakness, loss of appetite, trouble swallowing and seeing doctors. In [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) pain in the upper or middle right side of the abdomen may occur. In many types of cancer, the affected person may experience bowel problems such as abdominal pain and diarrhea. Other possible signs are loss of hair and skin, tiredness, fever and swelling of lymph nodes near the cancer.\n

Unverified Answer

What is tumors, solid?

Add answer

Gliomas (brain tumors) can be seen in different parts of the body. About 80 percent of patients with gliomas have a history of a previous diagnosis of glial cell cancer. Aspirin and other NSAIDs may contribute to or cause the development of malignant gliomas. The use of high doses of oral steroids has been found to increase the risk of developing a glioma. Immunosuppression for any cause is a risk factor for glioma development.\n

Unverified Answer

What causes tumors, solid?

Add answer

In the case of tumors, solid, cells have problems with their DNA and/or their proteins. This means that they are more prone to develop cancer-related problems. Some, but not all, of the cancer cells that have problems with their DNA and/or proteins will go on to cause problems and cancer will develop.

Unverified Answer

Can tumors, solid be cured?

Add answer

Tumor shrinkage in conjunction with a long period of remission can allow most patients to be cured of the solid-tumor components of these tumors. Patients with stage-III disease can benefit from the disappearance of solid tumors as well.

Unverified Answer

What are common treatments for tumors, solid?

Add answer

Most conventional treatments are employed, even when they are not necessary. Radiation therapy is a common treatment for brain tumors and the pelvic masses, while chemotherapy and radiotherapy are common treatments for melanoma, liver cancers and lung cancers.

Unverified Answer

Is bdb001 typically used in combination with any other treatments?

Add answer

Bdb001 is efficacious as-is against HGPCC and has the potential to reduce tumor volumes by nearly half in combination with the current standard treatment of cisplatin in combination with capecitabine.

Unverified Answer

What are the latest developments in bdb001 for therapeutic use?

Add answer

Since there was only one trial of the use of BDB001 in HCC that showed an increase in the progression-free survival, other clinical trials are needed. Inclusion of people for BDB001 trials that have a higher level of hepatic dysfunction would be helpful for confirmation of the favorable improvement in the outcome of patients.

Unverified Answer

Who should consider clinical trials for tumors, solid?

Add answer

The most common tumors, solid, are those with a cure that would prevent many patients from having to undergo surgery or chemotherapy. Clinical trials for solid tumors should focus on prevention and disease control rather than on "response" or "survival" outcomes.

Unverified Answer

What is the average age someone gets tumors, solid?

Add answer

There seems to be no consensus about what age people get tumors, solid. Several studies show an increasing trend of incidence of tumors in people older than 50 years, while other studies show a decreasing trend. There is still a need for further studies of the prevalence of tumors in different age groups to identify the true prevalence of the tumors in different age groups.

Unverified Answer

Is bdb001 safe for people?

Add answer

Bdb001 was well tolerated in people with ALK-positive non-small cell lung cancer with or without EGFR and ALK positive brain metastases. Future trials should define the most appropriate dosing and schedule, as well as compare Bdb001 to gefitinib or crizotinib.

Unverified Answer

How does bdb001 work?

Add answer

Overall, these data indicate that Bdb001 is a potent, selective, orally active, and potentiator of both VEGF receptor 1 activity and angiogenesis, suggesting promising clinical evaluation of this new antiangiogenic and anti-tumoral drug in a variety of solid malignancies for which enhanced vascularization may be an important factor in tumor progression and recurrence.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Tumors, Solid by sharing your contact details with the study coordinator.