Advanced Solid Tumor or LymphomaPhase 1NCT05115292
A First-in-Human, Phase 1 Dose-Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BJ-005 in Patients With Advanced Solid Tumor or Lymphoma
A Phase 1 study testing BJ-005 in people with Advanced Solid Tumor or Lymphoma, run by BJ Bioscience, Inc. at 6 sites in United States.
Trial summary
This is a first-in-human, Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of BJ-005 in patients with advanced solid tumor or lymphoma. BJ-005 is a recombinant bifunctional molecule, composed of a humanized anti-PD-L1 IgG1 monoclonal antibody (mAb) fused with a portion of the extracellular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor or Lymphoma
- What is being tested?
- BJ-005
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 6 sitesUnited States
- Study dates
- 20 Oct 2021to 20 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years.
- Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.
- Histologically or cytologically confirmed advanced solid tumors or lymphoma
- Measurable or evaluable disease per RECIST v1.1
- ECOG performance status 0 or 1
- Life expectancy ≥3 months
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- Adequate hepatic function
- Calculated creatinine clearance (CrCL) > 50 mL/min (Cockroft-Gault Equation)
- Adequate Hematological function
- Prothrombin time, international normalized ratio or activated partial thromboplastin time < 1.5 × ULN
- Recovery, to Grade 0-1, from adverse events related to prior anticancer therapy
Who cannot join
- Prior therapy with anti PD-L1/TGFβRⅡ targeting treatment.
- Symptomatic primary central nervous system (CNS) tumor of CNS metastases.
- Uncontrolled hypertension.
- Significant thrombotic or hemorrhagic events.
- Prior CAR-T therapy
- Severe cardiovascular disease.
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- Active infection requiring therapy
- Active HIV, hepatitis B or hepatitis C virus
- Active tuberculosis
- Anticancer therapy or radiation therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to study entry
- Pregnant or breast-feeding females
- Active or history of autoimmune disease or inflammatory disorders
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Next Oncology
Austin, Texas, 78758
Carolina BioOncology
Huntersville, North Carolina, 28078
Mayo Clinic - Florida
Jacksonville, Florida, 32224
Mayo Clinic - Phoenix
Phoenix, Arizona, 85054
Hematology/Oncology Assoc. of the Treasure Coast
Port Saint Lucie, Florida, 34952
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
About this study
Official title: A First-in-Human, Multicenter, Open-label, Phase 1 Dose-Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BJ-005 in Patients With Advanced Solid Tumor or Lymphoma
This is a first-in-human, Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of BJ-005 in patients with advanced solid tumor or lymphoma. BJ-005 is a recombinant bifunctional molecule, composed of a humanized anti-PD-L1 IgG1 monoclonal antibody (mAb) fused with a portion of the extracellular domain of human TGF-β receptor II (TGF-βRII).
- Conditions
- Advanced Solid Tumor or Lymphoma
- Being tested
- BJ-005
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BJ-005Biological
dosed with intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Arm1 | Experimental | BJ-005 dose escalation Receives: Biological: BJ-005 |
| Arm 2 | Experimental | BJ-005 cohort expansion Receives: Biological: BJ-005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the incidence and frequency of adverse events following intravenous (IV) infusion of BJ-005 in patients with advanced solid tumor or lymphoma. The assessment will be conducted per CTCAE 5.0 throughout the conduct of the study.
Measured: 60 days after the last dose
To determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of BJ-005 following IV infusion in patients with advanced solid tumor or lymphoma.
Measured: 60 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start20 Oct 2021
- Primary completion20 Oct 2024 (estimated)
- Study completion20 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumor or LymphomaStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BJ Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vicky Gao, MD, Study director, BJ Bioscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115292
- Sponsor's protocol ID
- BJ-005-01-001US
- Status last verified
- Nov 2023
- First submitted
- 20 Oct 2021
- Last updated
- 9 Nov 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Multicenter, Open-label, Phase 1 Dose-Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BJ-005 in Patients With Advanced Solid Tumor or Lymphoma
- ClinicalTrials.gov ID
- NCT05115292
- Acronym / sponsor ID
- BJ-005-01-001US
- Conditions
- Advanced Solid Tumor or Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- BJ Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 20 Oct 2024 (estimated)
- Study completion
- 20 Oct 2025 (estimated)
- First posted
- 10 Nov 2021 (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 first-in-human, Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of BJ-005 in patients with advanced solid tumor or lymphoma. BJ-005 is a recombinant bifunctional molecule, composed of a humanized anti-PD-L1 IgG1 monoclonal antibody (mAb) fused with a portion of the extracellular domain of human TGF-β receptor II (TGF-βRII).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm1 | Experimental | Biological: BJ-005BJ-005 dose escalation |
| Arm 2 | Experimental | Biological: BJ-005BJ-005 cohort expansion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female ≥ 18 years.
- Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.
- Histologically or cytologically confirmed advanced solid tumors or lymphoma
- Measurable or evaluable disease per RECIST v1.1
- ECOG performance status 0 or 1
Key exclusion criteria (12 listed)
- Prior therapy with anti PD-L1/TGFβRⅡ targeting treatment.
- Symptomatic primary central nervous system (CNS) tumor of CNS metastases.
- Uncontrolled hypertension.
- Significant thrombotic or hemorrhagic events.
- Prior CAR-T therapy
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 |
|---|---|---|
| BJ-005dosed with intravenous infusion | Biological | Arm 2, Arm1 |
Primary outcome
To evaluate the incidence and frequency of adverse events following intravenous (IV) infusion of BJ-005 in patients with advanced solid tumor or lymphoma. The assessment will be conducted per CTCAE 5.0 throughout the conduct of the study.
Time frame: 60 days after the last dose
To determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of BJ-005 following IV infusion in patients with advanced solid tumor or lymphoma.
Time frame: 60 days after the last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
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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.
Vicky Gao, MD study director
BJ Bioscience, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BJ-005 in people with Advanced Solid Tumor or Lymphoma, run by BJ Bioscience, Inc. at 6 sites in United States.
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 11 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 9 Nov 2023. 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 United States. 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?
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?
To evaluate the incidence and frequency of adverse events following intravenous (IV) infusion of BJ-005 in patients with advanced solid tumor or lymphoma. The assessment will be conducted per CTCAE 5.0 throughout the conduct of the study. (time frame: 60 days after the last dose). 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 9 Nov 2023.