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Advanced MalignanciesPhase 1BR105-INCT05351697

Clinical Study of BR105 Injection

A Phase 1 study testing BR105 injection in people with Advanced Malignancies, run by BioRay Pharmaceutical Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

A phase 1, dose escalation and dose expansion study of BR105 in patients with advanced malignancies. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Malignancies
What is being tested?
BR105 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteChina
Study dates
19 Apr 2022to 30 Oct 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Be willing to sign the Informed Consent Form (ICF), and can follow the visit schedule and procedures defined in the protocol.
  • 2. Male or female subject above 18 years old, no more than 75 years old.
  • 3. Phase Ia only: Histologically/cytologically confirmed, subjects with advanced malignancies or recurrent or refractory malignant lymphoma， standard treatment failure or intolerance or no standard and effective treatment region. Phase Ib only: Subjects will be limited to specific subjects according to the results of phase Ia, and it is preliminarily proposed to be subjects with relapsed and refractory B-cell non-Hodgkin's lymphoma and advanced gastric cancer.
  • 4. ECOG Performance Status 0 to 1.
  • 5. Subjects with life expectancy of ≥ 3 months.
  • 6. Phase Ia only: Subjects are not required to have measurable lesions at baseline, per RECIST v1.1 or Lugano 2014 criteria. Phase Ib only: Subjects must have at least one measurable lesion at baseline in phase Ib (bone metastasis or central nervous system (CNS) metastasis only is not accepted as a measurable lesion) , per RECIST v1.1 or Lugano 2014 criteria.
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  • 7. Any remaining toxicities from prior anti-tumor treatment should be restored to ≤ grade 1 as per CTCAE v5.0 or baseline level with exception of the residual hair loss.
  • 8. Must have adequate organ and bone marrow function (except for subjects who use any cell factors, growth factors and blood transfusion treatment within 14 days before enrollment), inculding the following
  • Neu≥ 1,500/mm3 (1.5×109/L)
  • PLT ≥100,000/mm3（100×109/L）
  • HGB ≥9g/dL（90g/L）
  • Cr ≤1.5×ULN or Ccr ≥ 50 ml/min
  • TBIL ≤1.5×ULN，subjects with liver metastasis or liver cancer ≤2×ULN
  • AST or ALT ≤2.5×ULN, subjects with liver metastasis or liver cancer≤5×ULN
  • INR ≤1.5， PT and APTT ≤1.5×ULN
  • 9. Female subjects of child-bearing potential must enter the study with a negative serum pregnancy test result. Female subjects of child-bearing potential or male subjects with female partners of child-bearing potential must be willing to use viable contraception method that is deemed effective by the investigator throughout the treatment period and for at least 6 months following the last dose of study drug

Who cannot join

  • 1. Subjects with known allergy to the test drug or any of its excipients, or severe allergic reaction to other monoclonal antibodies.
  • 2. Prior treatment with CD47 or signal regulatory protein alpha-targeting agents.
  • 3. History of hemolytic anemia (including Evans syndrome) or autoimmune thrombocytopenia caused by any reason within 3 months before the first administration of the test drug.
  • 4. Subjects who are receiving thrombolytic or anticoagulant therapy due to high risk of thrombosis.
  • 5. Received the following treatments or drugs before the first study treatment.
  • Subjects who have had major surgery within the 28-days from the first dosing, or plan to have major surgery during the study (tissue biopsy due to diagnosis is allowed).
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  • Subjects who have received immunosuppressive drugs within the 28-days from the first dosing; Subjects can receive nasal and inhaled corticosteroids or physiological doses of systemic steroid hormones (i.e. ≤ 10mg/day prednisone or other corticosteroids with equivalent pharmacological doses) in the absence of active autoimmune diseases.
  • Subjects who have received live attenuated vaccine within 28 days before the first dosing, or who plan to receive during the study and within 60 days after the last dosing.
  • Subjects who have received anti-tumor treatments (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biotherapy or tumor embolization) within 28 days before the first dosing, or used therapeutic radiopharmaceuticals within 56 days before the first trial drug treatment.
  • Subjects who have participated in other clinical trials and used trial related drugs within 28 days before the first dosing.
  • 6. Subjects with a history of active autoimmune diseases or autoimmune diseases that may recur, including but not limited to systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel diseases, Hashimoto's thyroiditis, etc., with exception of alternative treatment requirements (such as residual hypothyroidism caused by autoimmune thyroiditis).
  • 7. Subjects with metastatic cancer of central nervous system, uncontrollable pleural effusion, pericardial effusion or peritoneal effusion (except for subjects with indwelling catheter); Or subjects with uncontrollable hypercalcemia; Or subjects with spinal cord compression.
  • 8. Subjects with any other malignancies in the past 2 years, excluding fully cured cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, other malignancies that have been treated in the past and the current disease condition is stable, and other malignancies may benefit from this trial based on judgements of investigators.
  • 9. Positive for human immunodeficiency virus (HIV) antibody. Positive for treponema pallidum (TP) antibody. Positive for hepatitis C virus (HCV) antibody, and HCV RNA≥ the lower limit of detection. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), and HBV DNA ≥ 1ⅹ103IU/ml.
  • 10. Subjects with severe poorly controlled concomitant diseases, such as congestive heart failure (NYHA grade II or above), arrhythmias or angina pectoris that increase thromboembolic events, coronary artery stenting, angioplasty or coronary artery bypass grafting in recent 6 months, uncontrolled hypertension after treatment (systolic blood pressure ≥ 160mmhg or diastolic blood pressure ≥ 100mmhg), etc.
  • 11. Subjects with history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; If immunosuppressive transplantation is not required, it can be included (such as corneal transplantation and hair transplantation).
  • 12. Subjects with any active infection requiring systemic treatment by intravenous infusion occurred within 14 days before enrollment.
  • 13. Subjects who have active tuberculosis, or have received anti-tuberculosis treatment within 1 year prior to screening.
  • 14. Subjects with interstitial lung diseases, such as interstitial pneumonia, pulmonary fibrosis, or non-infectious pneumonia.
  • 15. Subjects who have suffered from diseases affecting intravenous infusion and venous blood collection currently.
  • 16. Subjects with known or suspected non-compliance with study protocol (e.g. psychotropic substance abuse, alcohol dependence, psychological disorder or drug abuse history).
  • 17. Pregnant or breastfeeding women.
  • 18. Subjects who, in the judgment of the investigator, are not suitable for enrollment or may not be able to complete the experiment for other reasons.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100000

Other trials in China

About this study

Official title: An Open-label, Dose Escalation and Dose Expansion, Phase I Study of BR105 Injection to Evaluate the Safety, Tolerability and Antitumor Activity in Patients With Advanced Malignant Tumors

A phase 1, dose escalation and dose expansion study of BR105 in patients with advanced malignancies.

Read the detailed description

This phase 1 clinical study is an open-label, multiple-dose, dose-escalation, dose-expansion, safety, PK, PD study of BR105. The phase 1 protocol will have 2 parts: a single agent dose escalation phase (Part 1) and dose expansion phase (Part 2). Approximately 40-162 adult patients are expected to be enrolled in the study.

The starting dose for phase I is 0.2 mg/kg, followed by 6 dose cohorts (1, 3, 10, 20, 30 and 40 mg/kg). Duration of dose limiting toxicity (DLT) observation is 21 days. Each subject will receive an intravenous infusion of BR105 on day 1 and be observed for 21 days after a single dose. Then Each subject will receive BR105 weekly.

Being tested
BR105 injection

What participants receive

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

  • BR105 injectionDrug

    0.2mg/kg, 1mg/kg, 3mg/kg, 10mg/kg, 20mg/kg, 30mg/kg, 40mg/kg respectively

Study groups in NCT05351697
Study groupRoleWhat they receive
BR105ExperimentalBR105 infusions will be administered weekly 21 days after the initial dose
Receives: Drug: BR105 injection

What is being measured

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

  1. Dose Limiting Toxicity (DLT) (Phase Ia)

    Number of subjects with a DLT

    Measured: Up to 3 weeks

  2. Maximum tolerated dose (MTD) (Phase Ia)

    Determine maximum tolerated dose (MTD) of BR105

    Measured: Up to 3 weeks

  3. Number of subjects with adverse events (Phase Ia)

    Number of subjects who experienced an adverse event

    Measured: Up to 12 months

  4. Objective response rate (ORR) (Phase Ib)

    Phase Ib, BR105 Antitumor Activity (ORR)

    Measured: Up to 2-3 years

  5. Recommended phase 2 dose (RP2D) (Phase Ib)

    Determine recommended phase 2 dose (RP2D) of BR105.

    Measured: Up to 2-3 years.

Secondary outcomes (7)

  1. Maximum serum concentration (Cmax) of BR105 (Phase Ia and Phase Ib )

    To determine the maximum serum concentration (Cmax) of BR105

    Measured: Up to 12 months for Phase Ia; Up to 2-3 years for Phase Ib

  2. Time of Maximum observed serum concentration (Tmax) of BR105 (Phase Ia and Phase Ib )

    To determine the Tmax of BR105.

    Measured: Up to 12 months for Phase Ia; Up to 2-3 years for Phase Ib

  3. Serum Half-life (T-HALF) of BR105.(Phase Ia and Phase Ib )

    To determine the t1/2 of BR105.

    Measured: Up to 12 months for Phase Ia; Up to 2-3 years for Phase Ib

  4. Objective response rate (ORR) (Phase Ia )

    Number of participants who achieved a best response of either complete response (CR) or partial response (PR) during treatment evaluated by investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or Lugano 2014.

    Measured: Up to 12 months for Phase Ia

  5. Progression free survival (PFS)(Phase Ia and Phase Ib )

    To determine the PFS by investigator.

    Measured: Up to 12 months for Phase Ia; Up to 2-3 years for Phase Ib

  6. Number of patients with adverse events (Phase Ia and Phase Ib )

    Incidence of AE as assessed by CTCAE 5.0

    Measured: Up to 12 months for Phase Ia; Up to 2-3 years for Phase Ib

  7. Immunogenicity (Phase Ia and Phase Ib )

    Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity of BR105

    Measured: Up to 12 months for Phase Ia; Up to 2-3 years for Phase Ib

Timeline

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

  1. First posted28 Apr 2022
  2. Study start19 Apr 2022
  3. Primary completion30 Oct 2025
  4. Study completion30 Oct 2025

Why it stopped: Company R\&D Strategy Adjustment

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
Other
Allocation
Not applicable
Intervention model
Sequential
Model description
Dose 1: 0.2 mg/kg, Dose 2: 1 mg/kg, Dose 3: 3 mg/kg, Dose 4: 10mg/kg, Dose 5: 20 mg/kg, Dose 6: 30 mg/kg, Dose 7: 40 mg/kg.
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05351697
Sponsor's protocol ID
BR105-I
Other IDs
CTR20220467, ChiCTR2200057711
Acronym
BR105-I
Status last verified
Nov 2025
First submitted
24 Apr 2022
Last updated
17 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BR105 injection in people with Advanced Malignancies, run by BioRay Pharmaceutical Co., Ltd. at 1 site in China.

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 16 inclusion and 23 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: stopped early, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 was stopped early (reason given: Company R\&D Strategy Adjustment). Results are not available in the source record.

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?

Dose Limiting Toxicity (DLT) (Phase Ia) (time frame: Up to 3 weeks). The study lists 5 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 NCT05351697.

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 17 Mar 2026.

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