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Monoclonal Antibodies

BB-1701 for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Bliss Biopharmaceutical (Hangzhou) Co., Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients (women of childbearing potential and males with fertile female partner) must be willing to use currently accepted reliable contraception method throughout the treatment period and for at least six months following the last dose of study drug. These measures include, but are not limited to, oral or implantable injections of hormonal contraceptives; intrauterine birth control ring or placement of IUS intrauterine device); or use of barrier methods such as condoms or septum and spermicide products. Postmenopausal women over 50 years of age must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Women of childbearing potential must have a negative pregnancy test ≤ 7 days prior to the first dose of investigational product
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

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/

Who is the study for?
This trial is for adults with advanced HER2-positive solid tumors that can't be removed or have spread, and who are in good physical condition (ECOG 0-1). They must have at least one measurable tumor and agree to use reliable contraception. People with certain medical conditions, uncontrolled diseases, recent major surgery, significant heart issues, active hepatitis B/C infection, pregnancy/breastfeeding status or those on current cancer treatments are excluded.Check my eligibility
What is being tested?
BB-1701 is being tested in this study which has two parts: finding the highest dose patients can take without serious side effects (dose escalation), and then giving that dose to more people to learn about its safety and how well it works against different cancers like breast or bladder cancer (cohort expansion).See study design
What are the potential side effects?
Since BB-1701 is a new drug being tested for the first time in humans, potential side effects aren't fully known yet. However, similar drugs often cause reactions where the drug enters the body, tiredness, nausea/vomiting/diarrhea; blood count changes increasing infection risk; organ inflammation; allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to use effective birth control during and 6 months after the study.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I can provide a recent sample of my tumor for testing.
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I have breast cancer that is hormone receptor positive and have had at least one hormonal treatment.
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My cancer is advanced, cannot be surgically removed, and has no curative treatment options.
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I have completed a break period after my last treatment before starting the study drug.
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I am 18 years old or older.
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I have had a brain MRI recently and my brain metastases are stable or not causing symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MTD
Number of subjects with adverse events and serious adverse events
Number of subjects with dose limiting toxicity (DLT)
Secondary outcome measures
Area under the serum concentration time curve from time 0 extrapolated to infinity (AUC0-inf)
Duration of Response
Incidence of anti-drug antibodies
+3 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Part 2: Cohort 2Experimental Treatment1 Intervention
Breast Cancer with HER2 low expressing
Group II: Part 2: Cohort 1Experimental Treatment1 Intervention
Breast Cancer with HER2 overexpressing or positive
Group III: Part 2 Cohort 4Experimental Treatment1 Intervention
Solid Tumors other than Breast Cancer and Gastric Cancer with HER2 overexpressing or positive
Group IV: Part 2 Cohort 3Experimental Treatment1 Intervention
Gastric Cancer or gastroesophageal junction cancer with HER2 overexpressing or positive
Group V: Part 1: Dose-escalationExperimental Treatment1 Intervention
Eight doses levels have been selected for evaluation in the Part 1 of the study. Dose escalation decisions will be determined based on toxicities observed during the first cycle ( 21 days or 28 days).

Find a Location

Who is running the clinical trial?

Bliss Biopharmaceutical (Hangzhou) Co., LtdLead Sponsor
3 Previous Clinical Trials
723 Total Patients Enrolled

Media Library

BB-1701 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04257110 — Phase 1
Solid Tumors Research Study Groups: Part 1: Dose-escalation, Part 2: Cohort 1, Part 2 Cohort 4, Part 2: Cohort 2, Part 2 Cohort 3
Solid Tumors Clinical Trial 2023: BB-1701 Highlights & Side Effects. Trial Name: NCT04257110 — Phase 1
BB-1701 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04257110 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~17 spots leftby Aug 2024