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Advanced Solid TumorPhase 1NCT06001580

A Study of BR101 Injection Alone in Subjects With Advanced Solid Tumors

A Phase 1 study testing BR101 in people with Advanced Solid Tumor, run by BioRay Pharmaceutical Co., Ltd. at 1 site in China.

Completed

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

Official record
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Trial summary

This study is a phase Ia study of single drug BR101 for Advanced solid tumor. The main purpose of this study is to Evaluate the safety and tolerability of BR101monotherapy (single dose and multiple doses) in Subjects with Advanced Solid Tumors and determine the MTD if possible, and determine the RP2D. 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?
BR101
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteChina
Study dates
11 Aug 2021to 7 Feb 2024
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. Patients who voluntarily sign the informed consent form with an understanding of the nature, purpose and procedures of the trial, and can comply the protocol;
  • 2. Males and females with an age of or above 18 years;
  • 3. Patients with advanced or metastatic solid tumors diagnosed by pathological histology and / or cytology (cell wax only) who are unable for radical surgical resection, or who have failed to standard treatment or who have been intolerant to standard treatment (disease progression, or intolerant to chemotherapy, targeted therapy, etc.), or who lack effective treatment;
  • 4. At least one measurable lesion according to RECIST V1.1;
  • 5. ECOG score ≤ 1;
  • 6. A recovery of previous treatment releated toxic reactions (except for the residual hair loss effect) to or under Grade 1 (according to CTCAE v 5.0) and a complete recovery of the immune-related adverse effects if the patients received anti-tumor treatment before;
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  • 7. Sufficient organ and bone marrow function;
  • 8. The expected survival above 12 weeks;
  • 9. Blood HCG test of females with a reproductive potential should be negative;
  • 10. Fertile men and women must use a highly effective contraceptive methods, and continue the birth control for six months after the last dose.

Who cannot join

  • 1. An current active autoimmune disease or history;
  • 2. A history of primary immunodeficiency;
  • 3. An current interstitial lung disease or history (except local interstitial lung disease induced by radiotherapy);
  • 4. An active tuberculosis or history;
  • 5. Any active infection that requires systemic treatment through intravenous infusion within 14 days before first dose;
  • 6. Two or more primary tumors (excluding cured cervical in situ carcinoma, basal cell carcinoma or squamous cell skin cancer, and other tumors that have been treated and stable for more than 5 years);
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  • 7. Symptomatic or untreated metastasis in brain or other central nervous system. However, patients with CNS matastasis that has been completed removed and/or be stable or relieved after radiotherapy can be enrolled;
  • 8. Uncontrollable pleural fluid, ascites, or pericardial effusion assesed by the investigator;
  • 9. Patients with any of the following heart diseases: any grade of heart failure assesed by NYHA, severe cardiac arrhythmias requiring treatment, Unstable angina pectoris，myocardial infarction occurred within 3 months before the first dose, QTc≥480 ms, hypertension that cannot in good control, receiving PTCA or CABG within 6 months before the first dose;
  • 10. Patients received anti-tumor therapy or participated in other clinical studies and used other test drugs 28 days before the first dose; Patients received the traditional Chinese medicine within 7 days before the first dose;
  • 11. A history of psychopathy;
  • 12. A history of major surgery or radiotherapy within 28 days before the first dose or expecting to operate a major surgery during the trial, a history of therapeutic radioactive agents within 56 days prior to the first dose;
  • 13. A history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
  • 14. Patients who have a bleeding tendency or are receiving thrombolytic or anticoagulant therapy;
  • 15. Patients who had been vaccinated within 28 days before the first dose or intend to be vaccinated during the trial;
  • 16. Patients who had a history of blood donation within 3 months before the first dose, or plan to donate blood during the trial;
  • 17. Patients who need to receive corticosteroids for more than 7 days (methylprednisolone > 10 mg/d or the equivalent dose) or other immunosuppressants within 14 days before the first dose, except for inhaled corticosteroids;
  • 18. Patients with a positive presence in terms of antibody to human immunodeficiency virus should be excluded; patients with a positive treponema pallidum specific antibody test require a further testing of the treponema pallidum non-specific antibody, and if the result is also positive, the subject shoule be excluded; patients with a positive hepatitis C virus antibody test require a further testing of the hepatitis C virus RNA [HCV RNA], and if the result is also positive, the subject shoule be excluded; patients with a positive hepatitis B virus antibody test require a further testing of the hepatitis B virus DNA [HBV DNA], and if the result is also positive, the subject shoule be excluded;
  • 19. Patients with diseases affecting intravenous injection and blood sample collection;
  • 20. Pregnant or lactating women;
  • 21. A plan to donate sperm from the signing of ICF to 6 months after the last dose;
  • 22. A situation or a possibility that patients can't comply the protocal;
  • 23. Other situations that are not suitable to attend this trial assesed by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Affiliated Hospital of Zhejiang University Medical College

    Hangzhou, Zhejiang, 310052

Other trials in China

About this study

Official title: A Phase Ia Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of BR101 Injection, as a Single Agent in Subjects With Advanced Solid Tumors

This study is a phase Ia study of single drug BR101 for Advanced solid tumor. The main purpose of this study is to Evaluate the safety and tolerability of BR101monotherapy (single dose and multiple doses) in Subjects with Advanced Solid Tumors and determine the MTD if possible, and determine the RP2D.

The secondary purpose of this study is to explore the Pharmacokinetics, Immunogenicity, Antitumor Activity of BR101 monotherapy (single dose and multiple doses) in Subjects with Advanced Solid Tumors

Being tested
BR101

What participants receive

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

  • BR101Drug

    BR101 injection was administered once for 28 days observation period and then weekly until the subject experienced unacceptable toxicity, disease progression, poor compliance, pregnancy, informed withdrawal, death, study interruption, and withdrawal from the study

Study groups in NCT06001580
Study groupRoleWhat they receive
BR101ExperimentalNot described
Receives: Drug: BR101

What is being measured

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

  1. Safety, Tolerability,RP2D

    The incidence and severity of various adverse events of DLT, evaluated per NCI CTCAE 5.0 standard, abnormal physical examination, vital signs, laboratory examination, 12-guided ECG, etc.; maximum tolerated dose (MTD)(if possible).

    Recommended Phase II clinical trial dose

    Measured: up to 91 days after the last administration

Secondary outcomes (13)

  1. Cmax

    Cmax

    Measured: From screening to 31 days after the last administration

  2. Tmax

    Tmax

    Measured: From screening to 31 days after the last administration

  3. AUC0-last

    AUC0-last

    Measured: From screening to 31 days after the last administration

  4. AUC0-tau

    AUC0-tau

    Measured: From screening to 31 days after the last administration

  5. Cmin

    Cmin

    Measured: From screening to 31 days after the last administration

  6. Immunogenicity assessment

    Anti-drug antibody (ADA) level produced by subjects

    Measured: From screening to 31 days after the last administration

  7. DCR

    DCR

    Measured: up to end of day 71

  8. DoR

    DoR

    Measured: up to end of day 71

  9. TTR

    TTR

    Measured: up to end of day 71

  10. CR

    CR

    Measured: up to end of day 71

  11. PFS

    PFS

    Measured: up to end of day 71

  12. Objective response rate(ORR)

    ORR

    Measured: up to end of day 71

  13. Pharmacodynamic assessment

    After administration, to evaluate Total/free CD73 level in peripheral blood, CD73 enzymatic activity in peripheral blood, CD73 level and CD73 occupancy of peripheral blood T lymphocytes, CD73 level and CD73 occupancy of tumor tissue, CD73 enzymatic activity in tumor tissue, CD8+ tumor infiltrating lymphocyte level in tumor tissue.

    Measured: UP to end of day 102

Timeline

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

  1. First posted21 Aug 2023
  2. Study start11 Aug 2021
  3. Primary completion27 Oct 2023
  4. Study completion7 Feb 2024

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
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06001580
Sponsor's protocol ID
BR101-I
Status last verified
Nov 2025
First submitted
4 Aug 2023
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 BR101 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 10 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: finished, 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 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?

Safety, Tolerability,RP2D (time frame: up to 91 days after the last administration). 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 NCT06001580.

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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