Solid TumorPhase 1NCT06932952
A Dose Escalation and Expansion Trial With BYON4228 Alone and in Combination in Patients With Advanced or Metastatic Solid Tumors
A Phase 1 study testing BYON4228 + Pembrolizumab in people with Solid Tumor, run by Byondis B.V. at 6 sites in 3 countries.
Trial summary
This is a phase I trial with BYON4228, a humanized monoclonal antibody (mAb) directed against signal regulatory protein (SIRP)α in solid tumors, alone and in combination with pembrolizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- BYON4228 + Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 7 May 2025to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Patient with histologically confirmed, locally advanced or metastatic cancer who has progressed on standard therapy or for whom no standard therapy exists:
- Part 1 (dose escalation): Solid tumors of any origin;
- Part 2 (expansion): Patients with other solid tumor types indicated for pembrolizumab monotherapy;
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1;
- For Part 2 only: at least one measurable cancer lesion as defined by the Response Evaluation Criteria for Solid Tumors (RECIST version 1.1);
- Adequate baseline organ function.
Who cannot join
- Having been treated with CD47 or SIRPα targeting agents or other anticancer therapy within 4 weeks prior to the start of IMP treatment;
- History of hypersensitivity or allergic reaction to any of the excipients of BYON4228;
- Any contraindication to pembrolizumab treatment;
- For Part 2: Patients previously given a PD-1 or PD-L1 inhibitor who had subsequent disease progression within 8 weeks of initiation;
- Symptomatic brain metastases;
- History of autoimmune disorders;
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- Severe active infection or other severe uncontrolled systemic disease;
- Having clinically significant cardiovascular disease;
- Known infection of Hepatitis B, C or E.
- Key inclusion and exclusion criteria details are listed here, additional requirements may apply.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Spain2 sites
CIOCC Hospital Universitario HM Sanchinarro
Madrid
Hospital Universitario Fundación Jiménez Díaz
Madrid
United Kingdom2 sites
The Christie NHS Foundation Trust
Manchester
The Royal Marsden
Sutton
About this study
Official title: A Dose Escalation and Expansion Trial With the SIRPα-directed Monoclonal Antibody BYON4228 Alone and in Combination to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy in Patients With Advanced or Metastatic Solid Tumors
This is a phase I trial with BYON4228, a humanized monoclonal antibody (mAb) directed against signal regulatory protein (SIRP)α in solid tumors, alone and in combination with pembrolizumab.
Read the detailed description
This study includes a dose escalation part (Part 1) in which the MTD or OBD and RDE(s) will be determined. This trial includes an expansion part (Part 2) to evaluate efficacy and safety of BYON4228 in combination with pembrolizumab in specific patient cohorts.
BYON4228 is a humanized IgG1 mAb directed against SIRPα. BYON4228 binds SIRPα expressed on innate immune cells, especially monocytes, macrophages and neutrophils. BYON4228 blocks binding of SIRPα to CD47 and inhibits signaling through the CD47-SIRPα axis.
- Conditions
- Solid Tumor
- Being tested
- BYON4228 + Pembrolizumab
- Keywords
- mAB, Monoclonal antibody, SIRPα, CD47, SIRP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BYON4228 + PembrolizumabDrug
BYON4228 is a humanized monoclonal antibody (mAb) directed against SIRPα. BYON4228 IV infusion every three weeks until disease progression or unacceptable toxicity. Different doses. Pembrolizumab IV infusion (200 mg) every three weeks from the second treatment cycle onwards.
| Study group | Role | What they receive |
|---|---|---|
| BYON4228 + Pembrolizumab | Experimental | Not described Receives: Drug: BYON4228 + Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities
Measured: 21 days
Objective Response Rate
Part 2 (expansion): To evaluate the objective tumor response rate (ORR).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start7 May 2025
- Primary completionApr 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Byondis B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932952
- Sponsor's protocol ID
- BYON4228.002
- Other IDs
- 2024-517952-37-00
- Status last verified
- Jan 2026
- First submitted
- 10 Apr 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalation and Expansion Trial With the SIRPα-directed Monoclonal Antibody BYON4228 Alone and in Combination to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy in Patients With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06932952
- Acronym / sponsor ID
- BYON4228.002
- Conditions
- Solid Tumor
- Keywords
- mAB, Monoclonal antibody, SIRPα, CD47, SIRP
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Byondis B.V.Industry (pharma, biotech, devices)
- Study start
- 7 May 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I trial with BYON4228, a humanized monoclonal antibody (mAb) directed against signal regulatory protein (SIRP)α in solid tumors, alone and in combination with pembrolizumab.
Detailed description
This study includes a dose escalation part (Part 1) in which the MTD or OBD and RDE(s) will be determined. This trial includes an expansion part (Part 2) to evaluate efficacy and safety of BYON4228 in combination with pembrolizumab in specific patient cohorts.
BYON4228 is a humanized IgG1 mAb directed against SIRPα. BYON4228 binds SIRPα expressed on innate immune cells, especially monocytes, macrophages and neutrophils. BYON4228 blocks binding of SIRPα to CD47 and inhibits signaling through the CD47-SIRPα axis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BYON4228 + Pembrolizumab | Experimental | Drug: BYON4228 + Pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with histologically confirmed, locally advanced or metastatic cancer who has progressed on standard therapy or for whom no standard therapy exists:
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1;
- For Part 2 only: at least one measurable cancer lesion as defined by the Response Evaluation Criteria for Solid Tumors (RECIST version 1.1);
- Adequate baseline organ function.
Key exclusion criteria (10 listed)
- Having been treated with CD47 or SIRPα targeting agents or other anticancer therapy within 4 weeks prior to the start of IMP treatment;
- History of hypersensitivity or allergic reaction to any of the excipients of BYON4228;
- Any contraindication to pembrolizumab treatment;
- For Part 2: Patients previously given a PD-1 or PD-L1 inhibitor who had subsequent disease progression within 8 weeks of initiation;
- Symptomatic brain metastases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BYON4228 + PembrolizumabBYON4228 is a humanized monoclonal antibody (mAb) directed against SIRPα. BYON4228 IV infusion every three weeks until disease progression or unacceptable toxicity. Different doses. Pembrolizumab IV infusion (200 mg) every three weeks from the second treatment cycle onwards. | Drug | BYON4228 + Pembrolizumab |
Primary outcome
Incidence of Dose-Limiting Toxicities
Time frame: 21 days
Objective Response Rate
Time frame: 2 years
Part 2 (expansion): To evaluate the objective tumor response rate (ORR).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BYON4228 + Pembrolizumab in people with Solid Tumor, run by Byondis B.V. 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?
The sponsor lists 6 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2026. 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 Belgium, 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of Dose-Limiting Toxicities (time frame: 21 days). 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?
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 Jan 2026.