Trial Title:
BI-1607 in Combination With Trastuzumab in Subjects With HER2-positive Advanced Solid Tumors
NCT ID:
NCT05555251
Condition:
HER2-positive Breast Cancer
HER2-positive Gastric Cancer
HER2-positive Metastatic Breast Cancer
Metastatic Gastroesophageal Junction Adenocarcinoma
Metastatic Gastric Adenocarcinoma
Conditions: Official terms:
Breast Neoplasms
Adenocarcinoma
Trastuzumab
Conditions: Keywords:
HER2-positive
solid tumours
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention 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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BI-1607
Description:
administered at different doses in Phase I by intravenous infusions every 3 weeks.
Arm group label:
Phase I -Dose escalation
Intervention type:
Drug
Intervention name:
BI-1607
Description:
administered at the recommended dose in Phase 2a by intravenous infusions every 3 weeks.
Arm group label:
Phase 2a - Expansion cohorts
Intervention type:
Drug
Intervention name:
Trastuzumab
Description:
administered at 8mg/kg for the first infusion and at 6mg/kg in subsequent infusions by
intravenous infusions every 3 weeks.
Arm group label:
Phase 2a - Expansion cohorts
Arm group label:
Phase I -Dose escalation
Other name:
Herceptin
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.
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Evang. Kliniken Essen-Mitte
Address:
City:
Essen
Zip:
45136
Country:
Germany
Facility:
Name:
Krankenhaus Nordwest
Address:
City:
Frankfurt
Zip:
60488
Country:
Germany
Facility:
Name:
Hospital Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Facility:
Name:
Complejo hospitalario Ruber Juan Bravo
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Facility:
Name:
Churchill Hospital
Address:
City:
Oxford
Zip:
OX3 7LE
Country:
United Kingdom
Facility:
Name:
Southampton General Hospital
Address:
City:
Southampton
Zip:
SO16 6YD
Country:
United Kingdom
Start date:
July 28, 2022
Completion date:
April 2024
Lead sponsor:
Agency:
BioInvent International AB
Agency class:
Industry
Source:
BioInvent International AB
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05555251
