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Locally Advanced/Metastatic HER2 Positive Solid TumorsPhase 1NCT04257110

A First-in-human Study of Multiple Doses of BB-1701 in Subjects With Locally Advanced/Metastatic HER2 Expressing Solid Tumors

A Phase 1 study testing BB-1701 in people with Locally Advanced/Metastatic HER2 Positive Solid Tumors, run by Bliss Biopharmaceutical (Hangzhou) Co., Ltd at 12 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label, first-in-human (FIH), phase 1 dose-escalation and cohort expansion study of BB-1701 in subjects with locally advanced/metastatic HER2 expressing solid tumors. The study consists of 2 parts: dose-escalation (Part 1) and cohort expansion (Part 2). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BB-1701
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
117 participants
Where
12 sitesin 2 countries
Study dates
28 Jul 2020to 31 Dec 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to provide written informed consent for the trial.
  • Male or female subject ≥ 18 years.
  • Patients must have a histologically or cytologically confirmed locally advanced unresectable or metastatic HER2 expressing solid tumor(s) for which no curative therapy is available or tolerable
  • 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
  • Patients must have at least one measurable lesion as defined per RECIST Version 1.1.
  • Patients must have a brain MRI (breast cancer only for part 2 cohort expansion) for the status of brain metastasis within 28 days prior to the first dose. Those with asymptomatic or stable CNS metastases are eligible for participation. However, patients with symptomatic and untreated CNS metastases, or those requiring ongoing treatment for CNS metastases, including steroids (>10 mg of prednisone or 4 mg of dexamethasone) and antiepileptic agents should not be enrolled in the study.
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  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy ≥12 weeks.
  • Subjects (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 seven months following the last dose of study drug.
  • 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.
  • Washout period required from the end of prior treatment to the first administration of the study drug
  • Be able to provide a fresh formalin-fixed, paraffin-embedded (FFPE) tumor tissue block, or 5-10 non-staining tumor slides (cohort 4 should be within 2 years) for evaluation or confirmation or exploratory diagnostic tests of HER2 status.

Who cannot join

  • Is receiving cancer therapy (chemotherapy or other systemic anti-cancer therapies, immunotherapy, radiation therapy, or surgery) at the time of enrollment.
  • Has not recovered from adverse events (e.g., not returned to baseline or grade 0~1) due to a previously administered agent.
  • Had major surgery within 4 weeks before dosing, or will not have fully recovered from surgery; or has surgery planned during the time the subject is expected to participate in the study or within 4 weeks after the last dose of study drug administration
  • Use of any investigational anti-cancer drug within 28 days before the first investigational product administration.
  • Has received prior cumulative doxorubicin dose > 360 mg/m² or equivalent
  • 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
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  • Has an active pneumonitis/interstitial lung disease (ILD), a history of pneumonitis/ILD that required systemic steroids, received radiotherapy to lung field within 12 months before the first dose of study intervention, or current clinically relevant lung disease (e.g. Chronic Obstructive Pulmonary Disease).
  • Has symptomatic or untreated CNS metastases, or those requiring ongoing treatment for CNS metastases, including steroids (>10 mg of prednisone or 4 mg of dexamethasone) and antiepileptic agents.
  • Any other serious underlying medical conditions, including but not limited to, uncontrolled diabetes mellitus, active uncontrolled infection, active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders
  • Patients has clinically significant cardiovascular disease.
  • QTc interval >/= 450 msecs for male or >/= 470 msecs for female [Fridericia's formula: QTcF=QT msec/(RR sec)0.33).
  • Current dyspnea at rest due to complications of advanced malignancy, or other diseases requiring continuous oxygen therapy.
  • Any other serious underlying medical conditions, including but not limited to, psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect subject compliance or place the subject at high risk from treatment-related complications.
  • History of seropositive status for human immunodeficiency virus (HIV) at any time before the start of treatment as determined by presence of anti-HIV-1 or anti-HIV-2 antibodies. Testing for seropositive status during Screening will be at the discretion of the investigator in participants without previously reported results.
  • Active hepatitis B, or hepatitis C infection. Participants will be tested for hepatitis C virus (HCV) and hepatitis B virus (HBV) at screening:
  • History of life-threatening hypersensitivity, or known to be allergic to protein drugs or recombinant proteins or excipients in BB-1701 drug formulation, or intolerance to trastuzumab or eribulin.
  • Females who are pregnant (positive beta-human chorionic gonadotropin positive [β-hCG] test) or breastfeeding.
  • Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol.
  • Unwillingness or inability to follow the procedures outlined in the protocol.

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

China9 sites

  • Cancer Hospital Chinese Academy of Medical Science

    Beijing, 100021

  • Sun Yat-sen Memorial Hospital

    Guangzhou

  • The First Affiliated Hospital of Zhejiang University

    Hangzhou, 310003

  • Sir Run Run Shaw Hospital - Zhejiang University School of Medicine

    Hangzhou

  • Zhejiang Cancer Hospital

    Hanzhou

  • Linyi Cancer Hospital

    Linyi

  • Jiangsu Province Hospital

    Nanjin, Jiangsu

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality

  • Hubei Cancer Hospital

    Wuhan

Other trials in China

United States3 sites

  • The Regents of NEXT Virginia, LLC

    Fairfax, Virginia, 22031

  • Sarah Cannon Research

    Nashville, Tennessee, 37203

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158

Other trials in United States

About this study

Official title: A First-in-human, Open Label, Multiple Dose, Dose Escalation and Cohort Expansion Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of BB-1701 in Subjects With Locally Advanced/Metastatic HER2 Expressing Solid Tumors

This is an open-label, first-in-human (FIH), phase 1 dose-escalation and cohort expansion study of BB-1701 in subjects with locally advanced/metastatic HER2 expressing solid tumors. The study consists of 2 parts: dose-escalation (Part 1) and cohort expansion (Part 2). Part 1 consists of dose escalation cohorts for determining the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). Part 2 consists of expansion cohorts, including but not limited to breast cancer, gastric/gastroesophageal junction cancer, bladder cancer and colon cancer, for exploring 1 or more RP2Ds or schedules for expanding/deepening the information/knowledge about clinical safety, clinical pharmacokinetics and anti-tumor activity.

Read the detailed description

This is an open-label, FIH, phase 1 dose-escalation and cohort expansion study of BB-1701 in subjects with locally advanced /metastatic HER2 expressing solid tumors. The study consists of 2 parts: dose-escalation (Part 1) and cohort expansion (Part 2).

Part 1 of this study will follow accelerated titration and traditional "3 + 3" design. Part 2 is a cohort expansion study with HER2 expressing locally advanced/metastatic solid tumors.

Part 2 consists of 4 cohorts:

Cohort 1: Patients with HER2 overexpressing or positive (defined as IHC 3+ or IHC 2+/FISH positive) locally advanced or metastatic breast cancer who have progressed on prior standard therapies including anti HER2 therapy

Cohort 2: Patients with HER2 low expressing (defined as IHC 2+ /FISH negative, or IHC 1+) locally advanced or metastatic breast cancer who have progressed on prior standard therapies.

Cohort 3: Patients with HER2 overexpressing or positive (defined as IHC 3+ or IHC 2+/FISH positive) locally advanced or metastatic gastric cancer or gastroesophageal junction cancer who have progressed on prior standard therapies.

Cohort 4: Patients with HER2 overexpressing or positive (defined as IHC 3+, or IHC 2+/FISH positive) locally advanced or metastatic solid tumors (other than breast cancer and gastric or gastroesophageal junction cancer) who have progressed on prior standard therapies. Patients with HER2 mutation or amplification by NGS can also be enrolled in this cohort.

Being tested
BB-1701
Keywords
Maximum tolerated dose, Recommended Phase 2 dose, First-in-human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BB-1701Drug

    BB-1701 will be administered as an intravenous infusion, every 3 weeks or every 4 weeks or every 6 weeks.

Study groups in NCT04257110
Study groupRoleWhat they receive
Part 1: Dose-escalationOtherEight 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).
Receives: Drug: BB-1701
Part 2: Cohort 1ExperimentalBreast Cancer with HER2 overexpressing or positive
Receives: Drug: BB-1701
Part 2: Cohort 2ExperimentalBreast Cancer with HER2 low expressing
Receives: Drug: BB-1701
Part 2 Cohort 3ExperimentalGastric Cancer or gastroesophageal junction cancer with HER2 overexpressing or positive
Receives: Drug: BB-1701
Part 2 Cohort 4ExperimentalSolid Tumors other than Breast Cancer and Gastric Cancer with HER2 overexpressing or positive
Receives: Drug: BB-1701

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of subjects with adverse events and serious adverse events

    To evaluate the safety and tolerability of BB-1701

    Measured: up to 2 years

  2. Number of subjects with dose limiting toxicity (DLT)

    Subjects are evaluated for all study drug related and treatment emergent toxicities based on the National Cancer Institute Common Toxicity Criteria for adverse events (NCI-CTCAE)

    Measured: Cycle 1. Duration of each cycle is 21 days.

  3. MTD

    MTD is defined as the highest dose level at which no more than 1 out of 6 subjects experiences a DLT during the first cycle.

    Measured: Cycle 1. Duration of each cycle is 21 days.

Secondary outcomes (6)

  1. Area under the serum concentration time curve from time 0 extrapolated to infinity (AUC0-inf)

    To characterize the pharmacokinetics (PK) of BB-1701

    Measured: Cycle 1 Day 1. Duration of each cycle is 21 days.

  2. Maximum observed plasma concentration (Cmax)

    To characterize the PK of BB-1701

    Measured: Pre-dose and post-dose during Cycle 1 through Cycle 8. Duration of each cycle is 21 days.

  3. Incidence of anti-drug antibodies

    To assess the immunogenicity of BB-1701

    Measured: Cycle 1 Day 1, Cycle 1 Day 15, and Day 1 of Cycles 2, 3, 4, 6, and 8. Duration of each cycle is 21 days.

  4. Objective response

    To assess the preliminary anti-tumor activity of BB-1701

    Measured: Every 9 weeks within 6 months and approximately every 12 weeks thereafter (up to 2 years)

  5. Progression Free Survival

    To assess the preliminary anti-tumor activity of BB-1701

    Measured: Every 9 weeks within 6 months and approximately every 12 weeks thereafter (up to 2 years)

  6. Duration of Response

    To assess the preliminary anti-tumor activity of BB-1701

    Measured: Every 9 weeks within 6 months and approximately every 12 weeks thereafter (up to 2 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2020
  2. Study start28 Jul 2020
  3. Primary completion31 Aug 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04257110
Sponsor's protocol ID
BB-1701-101
Status last verified
Jul 2025
First submitted
23 Jan 2020
Last updated
24 Jul 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Wang Y, Xia B, Cao L, Yang J, Feng C, Jiang F, Li C, Gu L, Yang Y, Tian J, Cheng X, Furuuchi K, Fulmer J, Verdi A, Rybinski K, Soto A, Albone E, Uenaka T, Gong L, Liu T, Qin Q, Wei Z, Zhou Y. Preclinical studies of BB-1701, a HER2-targeting eribulin-containing ADC with potent bystander effect and ICD activity. Antib Ther. 2024 Jun 25;7(3):221-232. doi: 10.1093/abt/tbae019. eCollection 2024 Jul.

    PubMed 39036069

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BB-1701 in people with Locally Advanced/Metastatic HER2 Positive Solid Tumors, run by Bliss Biopharmaceutical (Hangzhou) Co., Ltd at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects with adverse events and serious adverse events (time frame: up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04257110, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.

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