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TerminatedNCT05555251CONTRASTUpdated Dec 16, 2024

BI-1607 in Combination with Trastuzumab in Subjects with HER2-positive Advanced Solid Tumors

A Phase 1/2 interventional study of BI-1607 and BI-1607 in HER2-positive Breast Cancer, HER2-positive Gastric Cancer and HER2-positive Metastatic Breast Cancer, sponsored by BioInvent International AB. Terminated at 6 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-16.

Sponsored by BioInvent International AB · Phase 1/2, Interventional, and Treatment

Why this study was terminated
After the completion of phase IA, for business reasons it was decided to terminate the study.
Phase
Phase 1/2
Study type
Interventional
Enrollment
18
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

HER2+ breast and gastric cancer patients' survival is significantly improved by trastuzumab alone or in combination with chemotherapy. However, many patients remain uncured and develop resistance to trastuzumab resulting in relapse or progression of the disease. BI-1607, a human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) targets CD32b (Fc Gamma Receptor IIB), it is intended to enhance the efficacy and overcome resistance to existing cancer treatments such as trastuzumab.

This is a Phase 1/2a, first-in-human, open-label, multicenter, dose-escalation, consecutive-cohort study of BI-1607 in combination with trastuzumab in subjects with HER2+ advanced solid tumors whose tumor has progressed after standard therapy.

Read the detailed description

This is a Phase 1/2a, first-in-human, open-label, multicenter, dose-escalation, consecutive-cohort study of BI-1607 in combination with trastuzumab in subjects with HER2+ advanced solid tumors whose tumor has progressed after standard therapy.

The Phase 1 part of the trial is a dose escalation study of BI-1607 combined with trastuzumab in HER2+ advanced or metastatic solid tumors, the aim is to assess safety and tolerability and to determine the recommended phase II dose of BI-1607 in combination with trastuzumab.

The selected dose of BI-1607 will be studied in a subsequent Phase 2a part of the trial along with trastuzumab in 2 open-label, expansion cohorts of 15 evaluable subjects each. The first cohort will enroll subjects with locally advanced or metastatic HER2+ breast cancer, and the second will recruit subjects with HER2+ metastatic gastric or gastroesophageal junction adenocarcinoma. The aim of the phase 2a is to collect additional safety data to further support the recommended dose, and to detect early signs of clinical activity.

02

Conditions studied

  • HER2-positive Breast Cancer
  • HER2-positive Gastric Cancer
  • HER2-positive Metastatic Breast Cancer
  • Metastatic Gastroesophageal Junction Adenocarcinoma
  • Metastatic Gastric Adenocarcinoma

Keywords

  • HER2-positive
  • solid tumours
03

In context

Lead sponsor

BioInvent International AB is the lead sponsor of 11 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Main Inclusion Criteria:

  • Is willing and able to provide written informed consent for the trial.
  • Is ≥18 years of age on day of signing informed consent.
  • Has received standard of care or is intolerant to standard of care antineoplastic therapy. Subjects who are intolerant to trastuzumab cannot be enrolled in the study.
  • Has at least 1 measurable disease lesion as defined by RECIST v1.1 criteria.
  • Has a locally confirmed HER2+ tumor.

  • Must have progressive disease after the last line of treatment. In addition, subjects must have received the following previous lines of treatment:

    1. Prior lines of treatment including trastuzumab and chemotherapy.
    2. At least one prior line of treatment with an antibody-drug conjugate (ADC) (eg, trastuzumab-emtansine [TDM-1, or trastuzumab-deruxtecan]).

Main Exclusion Criteria:

  • Needs doses of prednisolone >10 mg daily (or equipotent doses of other corticosteroids) while on the trial other than as premedication.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Has cardiac or renal amyloid light-chain amyloidosis.
  • Has had clinically significant lung disease requiring systemic corticosteroid treatment within the last 6 months of enrollment.
  • Has an active, known, or suspected autoimmune disease.
  • Is at high medical risk because of nonmalignant systemic disease including severe active infections on treatment with antibiotics, antifungals, or antivirals.
  • Has presence of chronic graft versus host disease.
  • Has had an allogenic tissue/solid organ transplant.
  • Has uncontrolled or significant cardiovascular disease.
  • Has a known additional malignancy of another type, except for adequately treated cone-biopsied carcinoma in situ (eg, breast carcinoma, cervical cancer in situ), adequately controlled superficial bladder cancer, and basal or squamous cell carcinoma of the skin.
  • Has a diagnosis of primary or acquired immunodeficiency disorder or is taking any other form of immunosuppressive therapy.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Phase I -Dose escalation

    Dose escalation study of BI-1607 combined with trastuzumab in HER2+ advanced or metastatic solid tumors.

    Drug: BI-1607 · Drug: Trastuzumab

  • Experimental
    Phase 2a - Expansion cohorts

    Dose expansion study of BI-1607 combined with trastuzumab in cohort 1: HER2 positive locally advanced or metastatic HER2+ breast cancer and cohort 2: metastatic gastric or gastroesophageal junction adenocarcinoma

    Drug: BI-1607 · Drug: Trastuzumab

Interventions

06

What researchers measure

Primary outcomes

  1. Assessment of the safety and tolerability profile of BI-1607 in combination with trastuzumab

    Adverse events (AEs) and serious adverse events (SAEs) (graded according to the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] v5.0) and their causality in relation to BI-1607 or to the combination with trastuzumab

    Time frame: End of treatment visit or 30 days after last dose of study drug.

  2. Identify Dose limiting toxicities, determine the maximum tolerate dose of BI-1607 and propose a recommended Phase 2 dose (RP2D) for evaluation of BI-1607 in combination with trastuzumab.

    Occurrence of DLTs

    Time frame: 22 days

Secondary outcomes

  1. Assessment of the pharmacokinetic (PK) profile of BI-1607 when administered every 3 weeks in combination with trastuzumab

    The PK parameters will include area under the serum concentration-time curve, maximum concentration, time to maximum concentration, and terminal half-life

    Time frame: 90 days after the last dose of BI-1607

  2. Assessment of the immunogenicity of BI-1607 when administered in combination with trastuzumab

    Antidrug antibody response to BI-1607 in blood serum

    Time frame: 90 days after the last dose of BI-1607

  3. Assessment of the CD32b receptor occupancy (RO) of BI-1607 on B cells when administered in combination with trastuzumab

    RO on circulating B lymphocytes

    Time frame: 30 days after the last dose of BI-1607

  4. Assessment of the possible antitumor activity of BI-1607 in combination with trastuzumab

    Best tumor response, objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, progression-free survival (PFS), time to response, duration of response (DOR) and OS

    Time frame: 1 year after the last treatment

Other outcomes

  1. Exploratory: investigate expression levels of Fc receptors, and other immunological markers on immune cells infiltrating the tumor

    Expression levels of Fc receptors (eg, CD32b) and other markers of immunological activity using immunohistochemistry (IHC) and/or nucleotide-based assays using tissue samples

    Time frame: 1 day

  2. Exploratory: investigate the genetic background of subjects with respect to FcgammaR isoforms and explore a potential correlation of the genetic background with clinical responses

    Determination of Fcgamma receptor isoforms using nucleotide-based assays on genetic material extracted from whole blood

    Time frame: 1 day

  3. Exploratory: explore any exposure-response and/or exposure-safety relationship between BI-1607 serum concentrations and clinical outcome

    Correlation of BI-1607 PK and antitumor activity measures, as well as to safety measures of interest

    Time frame: 1 day

07

Study locations

6 sites
  • Evang. Kliniken Essen-Mitte
    Essen, 45136, Germany
  • Krankenhaus Nordwest
    Frankfurt, 60488, Germany
  • Hospital Vall d'Hebron
    Barcelona, 08035, Spain
  • Complejo hospitalario Ruber Juan Bravo
    Madrid, 28034, Spain
  • Churchill Hospital
    Oxford, OX3 7LE, United Kingdom
  • Southampton General Hospital
    Southampton, SO16 6YD, United Kingdom
08

References and documents

Publications

  • Cortes J, Priego A, Garralda E, Rojas K, Lord SR, Goetze TO, Kuemmel S, Crabb SJ, Parra-Guillen ZP, Borggren M, Karlsson I, Lindahl D, Martensson L, Oldham R, Ropenga A, Teige I, Wallin J, Frendeus B, McAllister A. A First-in-Class mAb (BI-1607) Targeting FcgammaRIIB: Preclinical Data and First-in-Human Studies in Patients with HER2-Positive Advanced Solid Tumors. Clin Cancer Res. 2025 Dec 1;31(23):4953-4963. doi: 10.1158/1078-0432.CCR-25-1348. PubMed 41071338 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2022 to primary completion in Feb 2024, 18 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 22, 2022
First posted
Sep 26, 2022
StartActual
Jul 28, 2022
Primary completionActual
Feb 7, 2024
CompletionActual
Feb 7, 2024
Last update
Dec 16, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05555251
Lead sponsor
BioInvent International AB
Responsible party
Sponsor
First posted
Sep 26, 2022
Start date
Jul 28, 2022
Primary completion
Feb 7, 2024
Completion
Feb 7, 2024
Last update
Dec 16, 2024

Study contacts

Andres McAllister, MD, PhD
study director · BioInvent International AB

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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