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BB-1701 for Solid Tumors
Study Summary
This trial is testing a new drug, BB-1701, to see if it is safe and effective in treating subjects with locally advanced/metastatic HER2 expressing solid tumors. The study consists of two parts: dose-escalation (Part 1) and cohort expansion (Part 2). Part 1 is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). Part 2 is to expand cohorts, including but not limited to breast cancer, gastric/gastroesophageal junction cancer, bladder cancer and colon cancer, to explore 1 or more RP2Ds or schedules and to expand/
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have severe nerve pain or had to stop treatment because of it.I still have side effects from previous treatments that haven't fully healed.I have received more than the maximum safe dose of doxorubicin.I do not have any serious health conditions like uncontrolled diabetes, infections, or bleeding problems.I am not pregnant or breastfeeding.I am willing to use effective birth control during and 6 months after the study.I have a serious heart condition.You have had a severe allergic reaction or are known to be allergic to certain types of protein drugs or ingredients in the BB-1701 drug. You have also experienced intolerance to trastuzumab or eribulin.I am currently undergoing cancer treatment.I am fully active or restricted in physically strenuous activity but can do light work.I need constant oxygen because of breathing problems from my advanced cancer.You are expected to live for at least 12 more weeks.I have lung problems like pneumonitis, ILD, or COPD, or had lung radiation in the last year.I have brain metastases needing treatment or causing symptoms.I can provide a recent sample of my tumor for testing.You have taken any experimental cancer medication in the 4 weeks leading up to the start of this study.I have breast cancer that is hormone receptor positive and have had at least one hormonal treatment.I have not had major surgery in the last 4 weeks and do not plan any during the study.My cancer is advanced, cannot be surgically removed, and has no curative treatment options.I am currently infected with hepatitis B or C.I have completed a break period after my last treatment before starting the study drug.I am 18 years old or older.I have had a brain MRI recently and my brain metastases are stable or not causing symptoms.
- Group 1: Part 1: Dose-escalation
- Group 2: Part 2: Cohort 1
- Group 3: Part 2 Cohort 4
- Group 4: Part 2: Cohort 2
- Group 5: Part 2 Cohort 3
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the Food and Drug Administration given its stamp of approval to BB-1701?
"BB-1701 has not been extensively tested, so it receives a score of 1. As this is a phase one trial, there are limited data on its efficacy and safety."
What aims is this research endeavor striving to accomplish?
"Spanning over Cycle 1, which last for 21 days, the primary purpose of this clinical trial is to determine Maximum Tolerated Dose. Secondary objectives comprise gauging BB-1701's preliminary anti-tumor activity through Objective Response and Progression Free Survival as well as discerning any immunogenic responses in patients with Anti Drug Antibodies."
How many individuals are actively involved in this research endeavor?
"Affirmative. According to data from clinicaltrials.gov, this medical study is currently in recruitment mode and was originally posted on July 28th 2020. The trial's most recent update took place on June 8th 2022 and the team are aiming to enrol 208 patients over 3 sites."
Is this clinical research still accepting participants?
"Affirmative. Information on clinicaltrials.gov verifies that this study is actively recruiting participants, which it began doing after being posted on July 28th 2020 and last updated June 8th 2022. The research requires the recruitment of 208 individuals over 3 sites."
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