A Trial of BI 765063 Monotherapy and in Combination With BI 754091 in Patients With Advanced Solid Tumours

  • End date
    Dec 31, 2022
  • participants needed
  • sponsor
    OSE Immunotherapeutics
Updated on 17 March 2021
platelet count
monoclonal antibodies
measurable disease
neutrophil count
solid tumour
investigational therapy
squamous cell carcinoma of the head and neck
targeted therapy
ovarian cancer


This trial will be a two steps Phase I clinical study in patients with advanced solid tumors with an escalating phase (Step 1) followed by an expansion phase (Step 2) of BI 765063, a monoclonal antibody (mAb) antagonist to signal regulatory protein alpha (SIRP) receptor, a myeloid checkpoint inhibitor administered as single agent, and in combination with BI 754091, a mAb antagonist to PD-1 receptor, a lymphocyte T checkpoint inhibitor.

Condition Solid Tumor, Adult, Solid Tumor, Adult, Solid Tumor, Adult, Solid Tumor, Adult, Solid Tumor, Adult, Solid Tumor, Adult, Solid Tumor, Adult
Treatment BI 754091, BI 765063
Clinical Study IdentifierNCT03990233
SponsorOSE Immunotherapeutics
Last Modified on17 March 2021


Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Solid Tumor, Adult?
Do you have any of these conditions: Do you have Solid Tumor, Adult??
Do you have any of these conditions: Do you have Solid Tumor, Adult??
Do you have any of these conditions: Do you have Solid Tumor, Adult??
Signed and dated, written informed consent form (ICF) prior to any trial-specific procedures
Male or female aged 18 years (no upper limit of age) at the time of ICF signature
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy of at least 3 months
Patients with a SIRP polymorphism including at least one V1 allele will be selected (i.e., homozygous V1/V1 or heterozygous V1/V2 in separate cohorts in escalation [Step
and only homozygous V1/V1 in expansion cohorts [Step 2]); SIRP polymorphism will be assessed in blood sampling (patient DNA) in a central laboratory; V1 allele is understood to include V1 and V1-like alleles
In Step 1: Patients with histologically or cytologically documented advanced/metastatic primary or recurrent malignancies who failed or are not eligible to standard therapy
In Step 2: Patients with histologically or cytologically documented
advanced/metastatic primary or recurrent solid tumors who failed or are not
eligible to standard therapy with the following tumour types: NSCLC, TNBC
pancreatic cancer, melanoma, HNSCC, RCC, UC, SCL, gastric cancer, CRC and
ovarian cancer. Patients included in Step 2 must have no alternative treatment
and have been previously treated with the standard of care therapy including
chemotherapy, targeted therapy and/or immune check-point inhibitors, as per
local guidelines (except if contra-indication and/or ineligibility)
\. Patients with at least one measurable lesion as per RECIST v1.1
\. Patients must agree to pre- and on-treatment tumor biopsies. Fresh tumor
biopsy may come either from the primary tumor or from a metastasis
Cytological material is not accepted. Archival tumor biopsy is acceptable, if
done within 4 weeks before the first treatment administration
Biopsy sites should be carefully selected by the investigator so that it is
safe for the patient and subsequent biopsy can be performed at the same
location; also if possible should be distinct from the measurable lesion
\. Adequate biological parameters defined as
Absolute neutrophil count (ANC) 1.5 x 10^9/L
Hemoglobin (Hb) level 10 g/dL. (without recent red blood cell transfusion within 2 weeks prior to study entry)
Platelet count 100 x 10^9/L
Total bilirubin level 1.5 X Upper Limit Normal (ULN), except for patients with Gilbert's syndrome from whom total bilirubin < 3.0 x ULN or direct bilirubin < 1.5 x ULN is authorized
Aspartate transaminase (AST) and alanine transaminase (ALT) 2.5 x ULN
Serum creatinine 1.5 ULN; or creatinine clearance > 50 mL/min (Chronic Kidney Disease Epidemiology [CKD-EPI] formula)
INR 1.5 (except if patient treated with anti-vitamin K); anticoagulation with anti-vitamin K and Low Molecular Weight Heparin [LMWH] is allowed
Prior major treatment-related surgery completed at least 28 days before study drug administration
In all cohorts
An interval of at least 28 days since the last chemotherapy, approved immunotherapy, biological or investigational therapy, radiation or tyrosine kinase inhibitor (TKI) therapy (sunitinib, sorafenib) must have elapsed before the first study drug administration(s)
And all toxicities related to previous anticancer therapies have resolved to normal value or to Grade 1 prior to the study treatment administration, except alopecia
Women must not be breastfeeding
Women of childbearing potential (WOCB) must agree to use highly effective methods of contraception (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly), prior to study entry, during the study and for 5 months after the last dose of study drug
Highly effective methods of contraception are defined as one of the following
methods: combined (estrogen and progestogen containing) hormonal contraception
associated with inhibition of ovulation (oral, intravaginal, transdermal)
progestogen-only hormonal contraception associated with inhibition of
ovulation (oral, injectable, implantable), intrauterine device (IUD)
intrauterine hormone-releasing system (IUS), bilateral tubal occlusion
vasectomised partner, sexual abstinence
\. Male patient with WOCBP partner must be willing to use male contraception
(condoms) during the study and until 5 months after last dose of study drug
WOCBP partners of male subjects participating in the study may use hormone
based contraceptives as one of the acceptable methods of contraception since
they will not be receiving study drug (i.e.; oral hormonal contraception, cap
diaphragm, or sponge with spermicide)
\. Females of childbearing potential must have a serum negative pregnancy
test within 7 days prior to first administration. Females who are
postmenopausal for at least 1 year (defined as more than 12 months since last
menses) or are surgically sterilized do not require this test
\. Capable of understanding and complying with protocol requirements
\. Patients must be affiliated to a social security system or an equivalent

Exclusion Criteria

Patient with symptomatic/active central nervous system (CNS) metastases; Patient with previously treated brain metastases are eligible, if there is no evidence of progression for at least 28 days before the first study treatment administration, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period
Other tumor location necessitating an urgent therapeutic intervention (e.g., palliative care, surgery or radiation therapy, such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture)
Presence of other active invasive cancers, other than the one treated in this trial, within 5 years prior to screening
Except appropriately treated basal cell carcinoma of the skin, or in situ
carcinoma of uterine cervix, or other local tumors considered cured by local
\. Patient with active autoimmune disease or a documented history of
autoimmune disease, that requires systemic treatment (i.e. corticosteroids or
immunosuppressive drugs)
Except patients with vitiligo, resolved childhood asthma/atopy, alopecia, or
any chronic skin condition that does not require systemic therapy, patients
with autoimmune-related hypothyroidism on a stable dose of thyroid replacement
hormone and/or controlled Type 1 diabetes mellitus on a stable insulin regimen
may be eligible
\. Known severe infusion related reactions to monoclonal antibodies (Grade 3
NCI-CTCAE v5.0) and patients removed from previous anti-PD-1 or anti-PD-L1
therapy because of a severe or life-threatening immune-related adverse event
(irAE) (Grade 3 NCI-CTCAE v5.0)
\. Patients receiving systemic treatment with any immunosuppressive
medication within one-week prior treatment start; Steroids of max. 10 mg
prednisolone equivalent per day are allowed, topical and inhaled steroids are
not considered as immunosuppressive
\. Patients with interstitial lung disease or active, non-infectious
\. Patient with uncontrolled disease-related metabolic disorders (e.g
hypercalcemia, SIADH) or uncontrolled diabetes
\. Patient with uncontrolled congestive heart failure defined as New York
Heart Association (NYHA) class III or IV, uncontrolled hypertension, unstable
heart disease (e.g., coronary artery disease with unstable angina or
myocardial infarction within 6 months before study treatment administration)
\. Patient with significant ECG abnormalities defined as any cardiac
dysrhythmia (> Grade 2) (i.e., significant ventricular arrhythmia as
persistent ventricular tachycardia and/or ventricular fibrillation; severe
conduction disorders as atrio-ventricular block 2 and 3, sino-atrial block) or
baseline QT/QTc interval >480 milliseconds (ms)
\. Patient with significant chronic liver disease (e.g., significant
fibrosis, known cirrhosis) or active HBV or HCV infection; If HbsAg positive
an effective antiviral treatment to prevent hepatitis B reactivation is
\. Patients with known Human Immunodeficiency Virus (HIV) infection or
patients with an active infection requiring specific anti-infective therapy
until all signs of infection have resolved, and this within 2 weeks prior to
the first study treatment administration
\. Patient whose medical, psychological including alcohol or drug abuse, or
surgical conditions are unstable and may affect the study completion and/or
compliance and/or the ability to give informed consent
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