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Advanced Solid TumorPhase 1NCT06289894

A Study of BRY805 in Participants With Advanced Solid Tumors

A Phase 1 study testing BRY805 injection in people with Advanced Solid Tumor, 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

This is a phase 1 open label multicenter study to evaluate safety, tolerance and the maximum tolerance of BRY805 administered intravenously (IV) once every three weeks in participants with advanced solid tumors, so as to confirm the recommended phase 2 dose of BRY805 and obtain the preliminary efficacy information of… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
BRY805 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteChina
Study dates
13 Mar 2024to 4 Jul 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

  • 1. Willing and able to provide signed informed and to comply with all study procedures; 2. Male or female ≥ 18 years; 3. Advanced malignant solid tumor patients who have experienced treatment failure using established therapeutic methods, have no viable standard treatment options available, or are unable to tolerate standard therapy; 4. ECOG score ≤ 1; 5. Life expectancy ≥ 3 months; 6. Considering that the phase I trial mainly evaluates the safety and tolerability of the drug, subjects who cannot measure the lesion can be enrolled in the dose escalation phase to obtain more safety, pharmacokinetic and pharmacodynamic results. Enrolled subjects who may have been expanded at 1-3 doses that may have been selected in the early period, have at least one measurable lesion in the baseline period according to RECIST v1.1; 7. Recovery, to Grade 0-1, from adverse events related to prior anticancer therapy except alopecia, < Grade 2 sensory neuropathy and endocrinopathies controlled with hormone replacement therapy; 8. Sufficient organ and bone marrow function; 9. Female subjects of childbearing age must have a negative serum pregnancy test result when they enter this study (tested within 1 week before the first dose); Female subjects of childbearing potential or male subjects whose sexual partner is a female of childbearing age, who are willing to use appropriate and effective contraceptive measures such as abstinence and double barrier methods (such as condoms plus contraceptive diaphragms), oral contraceptives, intrauterine device insertion, etc., during the study period and within 6 months after the last dose.

Who cannot join

  • 1. Hypersensitivity to study drug or components of its formulation; or have had a severe allergic reaction to other monoclonal antibodies; 2. Prior treatment with NKG2A-targeted agents; 3. Participants will be excluded if they meet any of the following criteria:
  • Major surgery within 4 weeks prior to the first dose, or anticipated major surgery during the study, minor surgery within 2 weeks prior to the first dose;
  • Use of immunosuppressive medications within 2 weeks prior to the first dose; nasal and inhaled corticosteroids or physiologic doses of systemic steroids (i.e., no more than 10 mg/day of prednisone or equivalent pharmacophysiological doses of other corticosteroids) are allowed in the absence of active autoimmune disease;
  • Live vaccine administration within 4 weeks prior to the first dose, at any time during the study, or within 1 month after the last dose; ④ Received anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy, or tumor embolization) within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose, or used therapeutic radiopharmaceuticals (strontium, samarium, etc.) within 8 weeks prior to the first dose; ⑤ Participation in other clinical trials within 4 weeks prior to the first dose.
  • 4. Active autoimmune disease or history of autoimmune disease that may recur, including but not limited to systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, Hashimoto's thyroiditis, etc. Except for conditions that require only alternative therapy (e.g., residual hypothyroidism due to autoimmune thyroiditis); 5. Symptomatic central nervous system metastases. Asymptomatic patients with CNS metastases who are radiographically and neurologically stable ≥for 4 weeks after CNS-directed therapy and are on stable or reduced doses of corticosteroids are eligible for study entry; 6. History of any malignancy within the past 5 years, with the exception of cured cervical carcinoma in situbasal, basal cell or squamous epithelial cell carcinoma of the skin, localized prostate cancer, ductal carcinoma in situ of the breast, or other malignancies that have been previously treated and judged by the investigator to have stable disease status; 7. Active HIV, hepatitis B or hepatitis C virus. A positive TP specific antibody test requires testing for syphilis non-specific antibodies; 8. Severe cardiovascular disease, including CVA, TIA, myocardial infarction, or unstable angina within 6 months of study entry; NYHA class III or IV heart failure within 6 months of study entry; Uncontrolled arrhythmia within 6 months of study entry; 9. QTcF interval ≥ 470 ms; 10. Uncontrolled hypertension (systolic blood pressure >160 mmHg and diastolic blood pressure >100 mmHg), a history of hypertension crisis, or a history of hypertensive encephalopathy; 11. Active infection requiring intravenous therapy within 2 weeks prior to the first dose; 12. Active tuberculosis, or anti-tuberculosis therapy within 1 year prior to screening; 13. Interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, etc., or non-infectious pneumonia; 14. Diseases affecting intravenous infusion and venous blood collection; 15. Has bleeding tendencies or is receiving thrombolytic or anticoagulant therapy; 16. History of allogeneic organ or stem cell transplantation; 17. History of prior grade 3-4 immune-related adverse events or immune-related adverse events requiring discontinuation of treatment; 18. Has a known or suspected condition that is incapable of complying with the study protocol (such as a history of psychotropic substance abuse, alcohol dependence, psychological disorder, or drug abuse); 19. Participants considered unsuitable for inclusion or who may not be able to complete the study for other reasons by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Shandong Tumor hospital

    Jinan, Shandong, 250117

Other trials in China

About this study

Official title: A Phase I, Open-label, Single Arm Study to Evaluate the Safety, Tolerability, and Antitumor Activity of BRY805 in Participants With Advanced Solid Tumors

This is a phase 1 open label multicenter study to evaluate safety, tolerance and the maximum tolerance of BRY805 administered intravenously (IV) once every three weeks in participants with advanced solid tumors, so as to confirm the recommended phase 2 dose of BRY805 and obtain the preliminary efficacy information of participants with advanced solid tumors.

Being tested
BRY805 injection

What participants receive

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

  • BRY805 injectionDrug

    BRY805 will be administered via IV infusion every 3 weeks. , Six dose levels of 0.3, 1, 3, 9,18 and 30 mg/kg will be tested

Study groups in NCT06289894
Study groupRoleWhat they receive
BRY805ExperimentalNot described
Receives: Drug: BRY805 injection

What is being measured

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

  1. Occurrence of Drug Limited Toxicities (DLTs)

    To assess by the occurrence of Drug Limited Toxicities (DLTs)

    Measured: From Time of First dose through DLT observation period, 21 days

  2. Type and incidence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs)

    To assess by the occurrence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs)

    Measured: From first dose until up to 91 days after the last dose

Secondary outcomes (5)
  1. BRY805 Serum Concentrations

    Serum concentrations will be calculated for BRY805

    Measured: From first dose to 31 days after the last dose

  2. Number of Participants with BRY805 Antibodies

    Antibodies to BRY805 will be assessed to evaluate potential immunogenicity

    Measured: From first dose to 31 days after the last dose

  3. Overall Response Rate (ORR)

    The proportion of participants who achieved CR or PR. Disease response will be assessed by the investigator using RECIST v1.1 and immune RECIST (iRECIST).

    Measured: Until study termination (approximately 2 years)

  4. Disease Control Rate (DCR)

    The proportion of participants who achieved stable disease (SD), PR, or CR

    Measured: Until study termination (approximately 2 years

  5. Progression-Free Survival (PFS)

    The time from the first dose to the first documented PD or death due to any cause, whichever occurs first

    Measured: Until study termination (approximately 2 years)

Timeline

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

  1. First posted4 Mar 2024
  2. Study start13 Mar 2024
  3. Primary completion16 May 2025
  4. Study completion4 Jul 2025

Why it stopped: Adjustment of the company's R\&D strategy

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06289894
Sponsor's protocol ID
BRY805-101
Status last verified
Nov 2025
First submitted
26 Feb 2024
Last updated
21 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BRY805 injection in people with Advanced Solid Tumor, 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 1 inclusion and 5 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 21 Nov 2025. 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: Adjustment of the company's R\&D strategy). 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?

Occurrence of Drug Limited Toxicities (DLTs) (time frame: From Time of First dose through DLT observation period, 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 21 Nov 2025.

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