Advanced Solid TumorPhase 1BT02NCT06404905
Clinical Trial of BT02 in Patients With Advanced Solid Tumors
A Phase 1 study testing BT02 monoclonal antibody injection in people with Advanced Solid Tumor, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
A First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Antitumor Activity of BT02 in Patients with Advanced Solid Tumors Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- BT02 monoclonal antibody injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 24 Jan 2024to 31 Dec 2024
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Age ≥18 at the time of signing the informed consent form, male or female;
- Patients must have histologically or cytologically confirmed diagnosis of advanced solid tumor;
- Adequate organ and hematologic function;
- Patients must have at least measurable or evaluable lesion in phase I and measurable lesion in phase II according to RECIST 1.1;
- ECOG performance status 0~1;
- Life expectancy ≥ 3 months;
- Good compliance and be willing to follow-up visit.
Who cannot join
- Receive treatment before study as below:
- Previous systematic anti-cancer therapy;
- Active or prior documented autoimmune disease within past 2 years;
- History of clinically significant cardiovascular disease;
- Significant acute or chronic infections;
- Prior toxicities from anti-cancer therapies have not regressed to grade ≤1 severity;
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- Any prior Grade≥3 irAE while receiving immunotherapy;
- Unstable brain metastasis or meningeal metastasis with clinical symptoms;
- Patients with mental disorders or poor compliance;
- Known alcohol or drug abuse;
- Other severe systemic diseases or conditions that unsuitable for participating in this study in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Institute and Hospital
Beijing, Biejing, 1000021
Ning Li, Doctor, 800-555-5555, lining@cicams.ac.cn
Li, Doctor
About this study
Official title: A First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Antitumor Activity of BT02 in Patients With Advanced Solid Tumors
A First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Antitumor Activity of BT02 in Patients with Advanced Solid Tumors
Read the detailed description
Overall study design:
This is an open-label, FIH, Phase I / II study of BT02 to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of BT02 in adult patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumor
- Being tested
- BT02 monoclonal antibody injection
- Keywords
- Advanced Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BT02 monoclonal antibody injectionDrug
It is expected to include 10-30 patients assigned to dose escalation cohorts.
| Study group | Role | What they receive |
|---|---|---|
| BT02 treatment | Experimental | BT02 given intravenously administer in patients with advanced solid tumors. Receives: Drug: BT02 monoclonal antibody injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity
safety
Measured: Within day 28 after administration
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Safety
Measured: Within day 28 after administration
Maximum tolerated dose
Maximum tolerated dose
Measured: Within day 28 after administration
Secondary outcomes (5)
The Pharmacokinetics characteristics of BT02
Levels of BT02 in blood
Measured: Within day 28 after administration
Progression-free survival (PFS)
The time from the date of first study treatment to the first occurrence of disease progression.
Measured: From date of enrollment until the date of revocation of informed consent, termination from the trial, or initiation of new anti-tumor treatment, loss of follow-up or death, whichever came first, assessed up to 100 months.
Overall survival (OS)
The time from the date of first study treatment to death from any cause.
Measured: From date of enrollment until the date of revocation of informed consent, termination from the trial, or initiation of new anti-tumor treatment, loss of follow-up or death, whichever came first, assessed up to 100 months.
Duration of response
The time from first occurrence of a documented response to disease progression.
Measured: From date of enrollment until the date of revocation of informed consent, termination from the trial, or initiation of new anti-tumor treatment, loss of follow-up or death, whichever came first, assessed up to 100 months.
Objective Response Rate (ORR)
The sum of the proportion of subjects with CR or PR
Measured: From date of enrollment until the date of revocation of informed consent, termination from the trial, or initiation of new anti-tumor treatment, loss of follow-up or death, whichever came first, assessed up to 100 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start24 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404905
- Sponsor's protocol ID
- BT02-101
- Acronym
- BT02
- Status last verified
- Dec 2024
- First submitted
- 19 Mar 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Antitumor Activity of BT02 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06404905
- Acronym / sponsor ID
- BT02 / BT02-101
- Conditions
- Advanced Solid Tumor
- Keywords
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 May 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.
A First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Antitumor Activity of BT02 in Patients with Advanced Solid Tumors
Detailed description
Overall study design:
This is an open-label, FIH, Phase I / II study of BT02 to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of BT02 in adult patients 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 |
|---|---|---|
| BT02 treatment | Experimental | Drug: BT02 monoclonal antibody injectionBT02 given intravenously administer in patients with advanced solid tumors. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 at the time of signing the informed consent form, male or female;
- Patients must have histologically or cytologically confirmed diagnosis of advanced solid tumor;
- Adequate organ and hematologic function;
- Patients must have at least measurable or evaluable lesion in phase I and measurable lesion in phase II according to RECIST 1.1;
- ECOG performance status 0~1;
Key exclusion criteria (11 listed)
- Receive treatment before study as below:
- Active or prior documented autoimmune disease within past 2 years;
- History of clinically significant cardiovascular disease;
- Significant acute or chronic infections;
- Prior toxicities from anti-cancer therapies have not regressed to grade ≤1 severity;
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 |
|---|---|---|
| BT02 monoclonal antibody injectionIt is expected to include 10-30 patients assigned to dose escalation cohorts. | Drug | BT02 treatment |
Primary outcome
Dose Limiting Toxicity
Time frame: Within day 28 after administration
safety
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Within day 28 after administration
Safety
Maximum tolerated dose
Time frame: Within day 28 after administration
Maximum tolerated dose
5 secondary outcomes
The Pharmacokinetics characteristics of BT02
Time frame: Within day 28 after administration
Progression-free survival (PFS)
Time frame: From date of enrollment until the date of revocation of informed consent, termination from the trial, or initiation of new anti-tumor treatment, loss of follow-up or death, whichever came first, assessed up to 100 months.
Overall survival (OS)
Time frame: From date of enrollment until the date of revocation of informed consent, termination from the trial, or initiation of new anti-tumor treatment, loss of follow-up or death, whichever came first, assessed up to 100 months.
Duration of response
Time frame: From date of enrollment until the date of revocation of informed consent, termination from the trial, or initiation of new anti-tumor treatment, loss of follow-up or death, whichever came first, assessed up to 100 months.
Objective Response Rate (ORR)
Time frame: From date of enrollment until the date of revocation of informed consent, termination from the trial, or initiation of new anti-tumor treatment, loss of follow-up or death, whichever came first, assessed up to 100 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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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.
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 BT02 monoclonal antibody injection in people with Advanced Solid Tumor, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 7 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 27 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ning Li, Dr (86 +15601395554, lining@cicas.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (time frame: Within day 28 after administration). The study lists 3 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 27 Dec 2024.