BI-1607 in Combination with Trastuzumab in Subjects with HER2-positive Advanced Solid Tumors
NCT ID: NCT05555251
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
18 participants
INTERVENTIONAL
2022-07-28
2024-02-07
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
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.
TREATMENT
NONE
Study Groups
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Phase I -Dose escalation
Dose escalation study of BI-1607 combined with trastuzumab in HER2+ advanced or metastatic solid tumors.
BI-1607
administered at different doses in Phase I by intravenous infusions every 3 weeks.
Trastuzumab
administered at 8mg/kg for the first infusion and at 6mg/kg in subsequent infusions by intravenous infusions every 3 weeks.
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
BI-1607
administered at the recommended dose in Phase 2a by intravenous infusions every 3 weeks.
Trastuzumab
administered at 8mg/kg for the first infusion and at 6mg/kg in subsequent infusions by intravenous infusions every 3 weeks.
Interventions
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BI-1607
administered at different doses in Phase I by intravenous infusions every 3 weeks.
BI-1607
administered at the recommended dose in Phase 2a by intravenous infusions every 3 weeks.
Trastuzumab
administered at 8mg/kg for the first infusion and at 6mg/kg in subsequent infusions by intravenous infusions every 3 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 \[TDM-1, or trastuzumab-deruxtecan\]).
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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BioInvent International AB
INDUSTRY
Responsible Party
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Principal Investigators
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Andres McAllister, MD, PhD
Role: STUDY_DIRECTOR
BioInvent International AB
Locations
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Evang. Kliniken Essen-Mitte
Essen, , Germany
Krankenhaus Nordwest
Frankfurt, , Germany
Hospital Vall d'Hebron
Barcelona, , Spain
Complejo hospitalario Ruber Juan Bravo
Madrid, , Spain
Churchill Hospital
Oxford, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
Countries
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References
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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 Monoclonal Antibody (BI-1607) Targeting FcgammaRIIB: Preclinical Data and First-in-Human Studies in Patients with HER2-Positive Advanced Solid Tumors. Clin Cancer Res. 2025 Oct 10. doi: 10.1158/1078-0432.CCR-25-1348. Online ahead of print.
Other Identifiers
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21-BI-1607-01
Identifier Type: -
Identifier Source: org_study_id