What side effects are associated with this type of intervention?

Common treatments for HER2-positive solid tumors, such as those being studied in the BB-1701 trial, include trastuzumab, trastuzumab-emtansine (T-DM1), and fam-trastuzumab deruxtecan (T-DXd). Trastuzumab is generally well tolerated but can cause chills, fever, nausea, vomiting, weakness, headache, and notably, cardiac dysfunction. T-DM1 can lead to decreased neutrophil count, anemia, nausea, and has shown CNS response rates in patients with brain metastases. T-DXd is associated with fatigue, nausea, diarrhea, and interstitial lung disease, which can be severe. These treatments highlight a range of hematologic and non-hematologic toxicities that need to be managed during therapy.

What prior FDA approvals exist?

Several FDA-approved treatments target the HER2 receptor in solid tumors, similar to the investigational drug BB-1701. Trastuzumab (Herceptin) is a monoclonal antibody that has been widely used for HER2-positive breast cancer. Trastuzumab emtansine (T-DM1) combines trastuzumab with a chemotherapy agent, showing efficacy in patients with previously treated HER2-positive breast cancer. Neratinib, an oral tyrosine kinase inhibitor, is approved in combination with capecitabine for advanced HER2-positive breast cancer after two or more prior anti-HER2 regimens. Lapatinib, another tyrosine kinase inhibitor, is also used with capecitabine for HER2-positive breast cancer, particularly in patients who have progressed on trastuzumab.

What other types of research exist?

Promising novel alternatives to BB-1701 for HER2 receptor targeting in solid tumors include: 1) BAY 80-6946, a PI3K alpha/delta inhibitor, which has shown potential in preclinical models of HER2-positive breast cancer with acquired resistance to trastuzumab and lapatinib. 2) Dual antibody-based HER2 blockade, as demonstrated in the APHINITY trial, which has shown efficacy in adjuvant settings. 3) Trastuzumab biosimilars, such as Herzuma®, which have been effective in heavily pretreated HER2+ metastatic breast cancer patients. These alternatives represent potential treatment strategies that could be considered for clinical trials or therapeutic use in 2024.

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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

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Patients with breast cancer who are estrogen receptor (ER) and/or progesterone receptor (PR) positive and in whom hormonal therapy is indicated (e.g., patients with positive ER and/or PR without rapidly progressive or extensive visceral metastases) must have received at least 1 prior line of hormonal therapy

Must not have

Has grade 2 or higher peripheral neuropathy, or had a history of grade 3 or higher peripheral neuropathy or had a history of treatment discontinuation due to peripheral neuropathy

Has not recovered from adverse events (e.g., not returned to baseline or grade 0~1) due to a previously administered agent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing BB-1701, an experimental drug, in patients with advanced or metastatic HER2-positive cancers. The drug aims to target and attack cancer cells with high levels of HER2, potentially stopping their growth. BB-1701 is an experimental drug targeting HER2-positive cancers, similar to other treatments like trastuzumab and lapatinib.

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.

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).

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 fully active or restricted in physically strenuous activity but can do light work.

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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 had a brain MRI recently and my brain metastases are stable or not causing symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe nerve pain or had to stop treatment because of it.

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I still have side effects from previous treatments that haven't fully healed.

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I have received more than the maximum safe dose of doxorubicin.

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I do not have any serious health conditions like uncontrolled diabetes, infections, or bleeding problems.

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I am not pregnant or breastfeeding.

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I have a serious heart condition.

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I am currently undergoing cancer treatment.

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I need constant oxygen because of breathing problems from my advanced cancer.

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I have lung problems like pneumonitis, ILD, or COPD, or had lung radiation in the last year.

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I have brain metastases needing treatment or causing symptoms.

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I am currently infected with hepatitis B or C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

MTD

Number of subjects with adverse events and serious adverse events

Number of subjects with dose limiting toxicity (DLT)

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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).

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for HER2-positive solid tumors, such as trastuzumab, trastuzumab emtansine (T-DM1), and trastuzumab deruxtecan (T-DXd), work by targeting the HER2 receptor on cancer cells. These therapies inhibit cancer cell growth and survival pathways and deliver cytotoxic agents directly to the cancer cells. This targeted approach is significant for patients as it enhances treatment efficacy and reduces side effects compared to traditional chemotherapy.

Mechanisms of breast cancer metastasis.The CARMA3-Bcl10-MALT1 Signalosome Drives NFκB Activation and Promotes Aggressiveness in Angiotensin II Receptor-Positive Breast Cancer.