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Solid Tumor, AdultPhase 1NCT03990233

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

A Phase 1 study testing BI 765063 and BI 754091 in people with Solid Tumor, Adult, run by OSE Immunotherapeutics at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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 (SIRPα) receptor, a myeloid checkpoint inhibitor administered as… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor, Adult
What is being tested?
BI 765063 and BI 754091
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
8 sitesin 2 countries
Study dates
16 Apr 2019to 30 Apr 2025
Phase
Phase 1
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

Who may be able to join

  • 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 SIRPα 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 1] and only homozygous V1/V1 in expansion cohorts [Step 2]); SIRPα 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;
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  • In Step 2: Cohort C1: Patients with histologically or cytologically advanced/metastatic primary or recurrent unresectable documented MSS colorectal tumors, whose disease relapsed after standard of care and who received no prior anti-PD-L1 inhibitors.
  • Cohort C2: Patients with histologically or cytologically advanced or metastatic documented MSS endometrial carcinoma whose disease relapsed after standard of care and who received no prior anti-PD-L1 inhibitors.
  • 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 system.

Who cannot join

  • 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 treatment;
  • 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.
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  • 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 pneumonitis.
  • 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 recommended.
  • 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.

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

France5 sites

  • Institut Bergonie

    Bordeaux, 33076

  • Hospital St Pierre

    La Réunion

  • Centre Léon Berard

    Lyon, 69373

  • Institut Claudius Regaud

    Toulouse, 31059

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Belgium3 sites

  • Institut Jules Bordet

    Brussels, 1000

  • Universitair Ziekenhuis Brussel

    Brussels, 1000

  • Universitair Ziekenhuis Gent

    Ghent, 9000

Other trials in Belgium

About this study

Official title: An Open-label Phase I Dose Finding Study of BI 765063, a Monoclonal Antibody (mAb) Antagonist of SIRPα, as Single Agent and in Combination With BI 754091, a Programmed Death-1 (PD-1) mAb, to Characterize Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy in Patients With Advanced Solid Tumours

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 (SIRPα) 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.

Being tested
BI 765063, BI 754091
Keywords
Checkpoint inhibitor (ICI), SIRPα, Advanced solid tumors, Anti-PD-1

What participants receive

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

  • BI 765063Drug

    Also called OSE-172

    mAb antagonist to SIRPα receptor, a myeloid checkpoint inhibitor

  • BI 754091Drug

    mAb antagonist to PD-1 receptor, a lymphocyte T checkpoint inhibitor

Study groups in NCT03990233
Study groupRoleWhat they receive
Step 1 (Dose escalation) : Cohorts AExperimentalBI 765063 (SIRPα inhibitor) alone in V1/V1 homozygous and V1/V2 heterozygous patients with advanced solid tumours
Receives: Drug: BI 765063
Step 1 (Dose escalation) : Cohorts BExperimentalBI 765063 (SIRPα inhibitor) in combination with BI 754091 (PD-1 inhibitor) in V1/V1 homozygous and V1/V2 heterozygous patients with advanced solid tumours
Receives: Drug: BI 765063; Drug: BI 754091
Step 2 (Expansion Cohorts) : Cohort C1ExperimentalBI 765063 (SIRPα inhibitor) in combination with BI 754091 (PD-1 inhibitor) in V1/V1 homozygous patients with metastatic colorectal cancer
Receives: Drug: BI 765063; Drug: BI 754091
Step 2 (Expansion Cohorts) : Cohort C2ExperimentalBI 765063 (SIRPα inhibitor) in combination with BI 754091 (PD-1 inhibitor) in V1/V1 homozygous patients with metastatic endometrium cancer
Receives: Drug: BI 765063; Drug: BI 754091

What is being measured

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

  1. Step 1 (dose escalation Parts A and B): Number of patients with Dose-Limiting Toxicities (DLTs) during the first treatment cycle

    Measured: 3 weeks (1 cycle)

  2. Step 1 (dose escalation Parts A and B): Maximum Tolerated Dose (MTD) determination

    Measured: 3 weeks (1 cycle)

  3. Step 2 (expansion combination Part C): Number of patients with DLT-like events during the whole treatment

    Measured: An average of 1 year

Secondary outcomes (6)

  1. Step 1: Number of patients with DLT-like events during the whole treatment

    Measured: An average of 1 year

  2. Step 1 and 2: Incidence and severity of all Adverse Events (AEs), Serious AEs (SAEs), AEs of special interest (AESIs), Immune related AEs (irAEs)

    Measured: An average of 1 year

  3. Step 2: Objective Response Rate (ORR) defined as best response of Complete Response (CR) and Partial Response (PR) as per RECIST v 1.1 and immune RECIST (iRECIST) criteria

    Measured: An average of 1 year

  4. Step 1 and 2: Cmax determination

    Measured: 12 weeks (4 cycles)

  5. Step 1 and 2: AUC 0-tz determination

    Measured: Up to 12 weeks (4 cycles)

  6. Step 1 and 2: Percentage and evolution of SIRPα receptor occupancy (RO) in blood at pre, on-treatment and after the end of treatment

    Measured: Up to 12 weeks (4 cycles)

Timeline

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

  1. First posted18 Jun 2019
  2. Study start16 Apr 2019
  3. Primary completion17 Apr 2023
  4. Study completion30 Apr 2025

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
* Step 1 (Dose escalation \[Cohorts A and B\]) primary objective : In V1/V1 homozygous and V1/V2 heterozygous patients with advanced solid tumors, Dose-Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of BI 765063, as monotherapy (Cohort A) and in combination with BI 754091 (Cohort B). * Step 2 (Expansion Cohorts \[Cohorts C\]) primary objective : In V1/V1 homozygous patients with selected advanced solid tumors (colorectal or endometrium), DLT-like events and RP2D confirmation of BI 765063 in combination with BI 754091.
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03990233
Sponsor's protocol ID
1443-0001
Other IDs
2018-003830-34, 2018
Status last verified
Jun 2025
First submitted
21 May 2019
Last updated
26 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 765063 and BI 754091 in people with Solid Tumor, Adult, run by OSE Immunotherapeutics at 8 sites in 2 countries.

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

Who may be eligible to take part?

The sponsor lists 30 inclusion and 15 exclusion criteria. 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: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France, Belgium. 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 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.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Step 1 (dose escalation Parts A and B): Number of patients with Dose-Limiting Toxicities (DLTs) during the first treatment cycle (time frame: 3 weeks (1 cycle)). The study lists 3 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 NCT03990233.

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 26 Jun 2025.

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