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HER2-positive Breast CancerPhase 1/2CONTRASTNCT05555251

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

A Phase 1/2 study testing BI-1607 and Trastuzumab in people with HER2-positive Breast Cancer and HER2-positive Gastric Cancer, run by BioInvent International AB at 6 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BI-1607 and Trastuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
6 sitesin 3 countries
Study dates
28 Jul 2022to 7 Feb 2024
Phase
Phase 1/2
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

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.

Trial locations and contacts

6 sites in 3 countries.

6 sites in 3 countries

Germany2 sites

  • Evang. Kliniken Essen-Mitte

    Essen, 45136

  • Krankenhaus Nordwest

    Frankfurt, 60488

Other trials in Germany

Spain2 sites

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Complejo hospitalario Ruber Juan Bravo

    Madrid, 28034

Other trials in Spain

United Kingdom2 sites

  • Churchill Hospital

    Oxford, OX3 7LE

  • Southampton General Hospital

    Southampton, SO16 6YD

Other trials in United Kingdom

About this study

Official title: Phase 1/2a Open-label Clinical Trial of BI-1607, an Fc-Engineered Monoclonal Antibody to CD32b (FcγRIIB), in Combination with Trastuzumab in Subjects with HER2-positive Advanced Solid Tumors

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.

Being tested
BI-1607, Trastuzumab
Keywords
HER2-positive, solid tumours

What participants receive

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

  • BI-1607Drug

    administered at different doses in Phase I by intravenous infusions every 3 weeks.

  • BI-1607Drug

    administered at the recommended dose in Phase 2a by intravenous infusions every 3 weeks.

  • TrastuzumabDrug

    Also called Herceptin

    administered at 8mg/kg for the first infusion and at 6mg/kg in subsequent infusions by intravenous infusions every 3 weeks.

Study groups in NCT05555251
Study groupRoleWhat they receive
Phase I -Dose escalationExperimentalDose escalation study of BI-1607 combined with trastuzumab in HER2+ advanced or metastatic solid tumors.
Receives: Drug: BI-1607; Drug: Trastuzumab
Phase 2a - Expansion cohortsExperimentalDose 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
Receives: Drug: BI-1607; Drug: Trastuzumab

What is being measured

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

  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

    Measured: 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

    Measured: 22 days

Secondary outcomes (4)

  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 1 year after the last treatment

Timeline

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

  1. First posted26 Sep 2022
  2. Study start28 Jul 2022
  3. Primary completion7 Feb 2024
  4. Study completion7 Feb 2024

Why it stopped: After the completion of phase IA, for business reasons it was decided to terminate the study.

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
This is a Phase 1/2a, FIH, open-label, multicenter, dose-escalation, consecutive-cohort study of BI-1607 in combination with trastuzumab. The study will consist of 2 Phases: * Phase 1, the dose-escalation part of the study, the aim of which is to assess safety and tolerability and to determine the RP2D of BI-1607 in combination with trastuzumab in subjects with HER2+ advanced solid tumors. * Phase 2a, comprising of 2 separate expansion cohorts treated at the RP2D of BI-1607 in combination with trastuzumab in subjects with locally advanced or metastatic HER2+ breast cancer and subjects with HER2+ metastatic gastric or gastroesophageal junction adenocarcinoma. The aim of Phase 2a is to collect additional safety data to further support RP2D, and to detect early signs of clinical activity.
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05555251
Sponsor's protocol ID
21-BI-1607-01
Acronym
CONTRAST
Status last verified
Dec 2024
First submitted
22 Sep 2022
Last updated
16 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BI-1607 and Trastuzumab in people with HER2-positive Breast Cancer and HER2-positive Gastric Cancer, run by BioInvent International AB at 6 sites in 3 countries.

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

Who may be eligible to take part?

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: stopped early, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany, Spain, United Kingdom. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was stopped early (reason given: After the completion of phase IA, for business reasons it was decided to terminate the study.). Results are not available in the source record.

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?

Assessment of the safety and tolerability profile of BI-1607 in combination with trastuzumab (time frame: End of treatment visit or 30 days after last dose of study drug.). The study lists 2 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 NCT05555251, 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 16 Dec 2024.

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