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.
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.
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.
- Conditions
- Advanced Solid Tumor
- 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 group | Role | What they receive |
|---|---|---|
| BRY805 | Experimental | Not described Receives: Drug: BRY805 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
BRY805 Serum Concentrations
Serum concentrations will be calculated for BRY805
Measured: From first dose to 31 days after the last dose
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
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)
Disease Control Rate (DCR)
The proportion of participants who achieved stable disease (SD), PR, or CR
Measured: Until study termination (approximately 2 years
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.
- First posted4 Mar 2024
- Study start13 Mar 2024
- Primary completion16 May 2025
- Study completion4 Jul 2025
Why it stopped: Adjustment of the company's R\&D strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioRay Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06289894
- Acronym / sponsor ID
- BRY805-101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Adjustment of the company's R\&D strategy
- Enrolment
- 13 participants (actual)
- Lead sponsor
- BioRay Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 16 May 2025 (actual)
- Study completion
- 4 Jul 2025 (actual)
- First posted
- 4 Mar 2024 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BRY805 | Experimental | Drug: BRY805 injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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:
- 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.
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 |
|---|---|---|
| BRY805 injectionBRY805 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 | Drug | BRY805 |
Primary outcome
Occurrence of Drug Limited Toxicities (DLTs)
Time frame: From Time of First dose through DLT observation period, 21 days
To assess by the occurrence of Drug Limited Toxicities (DLTs)
Type and incidence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs)
Time frame: From first dose until up to 91 days after the last dose
To assess by the occurrence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs)
5 secondary outcomes
BRY805 Serum Concentrations
Time frame: From first dose to 31 days after the last dose
Number of Participants with BRY805 Antibodies
Time frame: From first dose to 31 days after the last dose
Overall Response Rate (ORR)
Time frame: Until study termination (approximately 2 years)
Disease Control Rate (DCR)
Time frame: Until study termination (approximately 2 years
Progression-Free Survival (PFS)
Time frame: Until study termination (approximately 2 years)
Results and safety
The study was stopped early (reason given: Adjustment of the company's R\&D strategy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
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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.
1 site in 1 country: see every site and its status.
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.