Solid TumoursPhase 1BH002-Ⅰ-101NCT06231277
Phase I Clinical Trial of BH002 in Patients With Advanced Solid Tumors
A Phase 1 study testing BH002 in people with Solid Tumours, run by Zhuhai Beihai Biotech Co., Ltd at 2 sites in China.
Trial summary
The goal of this clinical trial is to about in Patients With Advanced Solid Tumors. The main question[s] it aims to answer are: question 1:Evaluating the tolerability of BH002 injection in Chinese patients with advanced solid tumors question 2:Obtain the pharmacokinetic (PK) characteristics of BH002 injection in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumours
- What is being tested?
- BH002
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesChina
- Study dates
- 26 Apr 2022to 31 Mar 2023
- 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
- Age ≥18 years old, male or female.
- Patients were diagnosed advanced solid tumors by histology or cytology (preferably prostate cancer, gastric cancer, non-small cell lung cancer, breast cancer, esophageal cancer, head and neck squamous cell carcinoma, ovarian cancer, liposarcoma, etc.) whose disease progresses after standard treatment.
- ECOG score 0~2, expected survival time ≥3 months.
- Have adequate hematology and organ function, and meet the following conditions based on laboratory test results within 7 days before the first dose:1)For those who have not received blood transfusions, blood products or blood cytokines such as granulocyte colony-stimulating factor (G-CSF) within 14 days of the first dose, blood routine: neutrophil count ≥2.0×109/L, platelet count ≥100×109 /L, white blood cell count ≥4.0×109/L, hemoglobin concentration ≥8.0g/dL. 2)Blood biochemistry: liver function: aspartate aminotransferase and alanine aminotransferase ≤1.5 times the upper limit of normal (ULN), total bilirubin ≤ULN. kidney function: creatinine ≤1.5×ULN.
- Baseline left ventricular ejection fraction determined by echocardiography ≥50%, normal or abnormal 12-lead electrocardiogram without clinical significance, QTc interval <450ms (men) or <470ms (women), and no symptoms or signs of heart failure.
- The functions of major organs (heart, lung, liver, kidney, bone marrow, gastrointestinal) are basically normal or abnormal without clinical significance, and acute toxicity caused by previous treatment is relieved to ≤ grade 1 (except for hair loss).
Show all 10Show fewer
- If the subject has been previously treated with surgery, chemotherapy, immunotherapy, biologic therapy, targeted therapy, anti-tumor traditional Chinese medicine, or small molecule targeted drug, the first dose should be given at an interval of 4 weeks or more than 5 half-lives (whichever is shorter)；If the chemotherapeutic agent is mitomycin or nitrosourea, the first dose needs to be given more than 6 weeks apart.
- The first dose was more than 6 weeks after the last radiotherapy (except palliative radiotherapy for local pain control), and there was no previous whole-pelvic radiotherapy (radiotherapy ≤30% of the bone marrow area).
- With the consent of the individual and an informed consent form signed by the individual or his legal representative.
- The subject can communicate well with the researcher and complete the research in accordance with the research regulations.
Who cannot join
- Those who have received cabazitaxel in the past.
- Those who are severely allergic to cabazitaxel, human albumin, or alcohol.
- Currently receiving other anti-tumor therapys.
- Patients receiving systemic therapy with glucocorticoids (>10 mg/d prednisone or equivalent dose of steroids) or other immunosuppressants within 14 days before the first dose. In the absence of active autoimmune disease, inhaled or topical glucocorticoids can be used, and hormone replacement therapy doses ≤10 mg/d prednisone equivalent are allowed.
- Those who need to use strong inhibitors or inducers of CYP3A4 within 14 days of the first dose and during the study.
- Those with clinically significant mental or central nervous system diseases.
Show all 16Show fewer
- Those with active brain metastasis.
- Those with two or more malignant tumors (except cured non-melanoma skin cancer, cervical cancer, thyroid cancer and gastrointestinal intramucosal cancer)
- Subjects who have received 2 or more prior treatments with mitomycin or nitrosoureas, or subjects who have received prior intensive therapy with autologous stem cell transplantation.
- Those with serious medical diseases:1)Existence of clinically important cardiovascular and cerebrovascular diseases, including: severe or uncontrollable heart disease that requires treatment, congestive heart failure rated ≥ grade 3 by the New York Heart Association (NYHA), and unstable angina that cannot be controlled by drugs. A history of myocardial infarction within 6 months before enrollment, and severe arrhythmia requiring drug treatment (except for atrial fibrillation or paroxysmal supraventricular tachycardia). 2)Those with indwelling cardiac stent within 6 months.3)Uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg), diabetes, pleural effusion, pericardial effusion, and ascites. 4)Uncontrolled peptic ulcer, or other uncontrolled thromboembolic event. 5)Patients with interstitial lung disease, pulmonary fibrosis, or a history of pneumonia who require steroid treatment.
- People who are infected with HIV, HBV [those who are positive for hepatitis B surface antigen (HBsAg) and whose HBV-DNA is higher than 1000IU/mL], HCV ( those who are HCV-Ab positive and whose HCVRNA detection copy number is higher than normal upper limit)and Treponema pallidum.
- Those with a history of drug abuse.
- Women who are pregnant or lactating. female patients of childbearing potential who have a positive pregnancy test within 7 days before the first dose. any male and female patients of childbearing potential do not consent to the use of a medically recognized effective method of contraception throughout the trial and for 3 months after final trial drug administration.
- Those who have participated in other drug clinical trials within 28 days before the first dose.
- Those who have been vaccinated within 30 days before the first dose or vaccinated during the study period (except for inactivated vaccines).
- Other circumstances in which the researcher deems it inappropriate to participate in this trial.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Hunan Cancer Hospital
Changsha, Hunan
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
About this study
Official title: Phase I Clinical Trial of Safety, Tolerability and Pharmacokinetics of BH002 in Patients With Advanced Solid Tumors
The goal of this clinical trial is to about in Patients With Advanced Solid Tumors. The main question[s] it aims to answer are:
- question 1:Evaluating the tolerability of BH002 injection in Chinese patients with advanced solid tumors
- question 2:Obtain the pharmacokinetic (PK) characteristics of BH002 injection in Chinese patients with advanced solid tumors
Read the detailed description
Subjects will be administered BH002 intravenously. It is expected that there will be 2 to 4 dose groups, with 3 to 6 subjects enrolled in each group. The doses from low to high are 15 mg/m2,20 mg/m2,25 mg/m2,30 mg/m2,35 mg/m2. Subjects were injected with BH002 intravenously on the first day of each cycle, once during a 3-week period.
The dose escalation for this trial will be 20mg/m2 as the starting dose. According to the traditional "3+3" dose escalation principle, 3 subjects are planned to be enrolled in each dose group at the same time. Safety, tolerability, and dose-limiting toxicities (DLTs) will be assessed within 21 days of first dose.
- Conditions
- Solid Tumours
- Being tested
- BH002
- Keywords
- Phase I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BH002Drug
Every 21 days constitutes a treatment cycle, and administration begins on the first day of each cycle
| Study group | Role | What they receive |
|---|---|---|
| BH002 | Experimental | Every 21 days constitutes a treatment cycle, and administration begins on the first day of each cycle Receives: Drug: BH002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the tolerability of BH002 in Chinese patients with advanced solid tumors.
dose-limiting toxicity [DLT]
Measured: 21 days after first dose
Evaluating the tolerability of BH002 in Chinese patients with advanced solid tumors.
maximum tolerated dose [MTD]
Measured: 21 days after first dose
Obtain the pharmacokinetic characteristics of BH002 in Chinese patients with advanced solid tumors.
Maximum Plasma Concentration [Cmax], etc,
Measured: 216 hours after first dose
Secondary outcomes (3)
To evaluate the safety of BH002 in Chinese patients with advanced solid tumors.
Rates and severity of adverse events.
Measured: From first dose to 30 days after last dose
Evaluating the preliminary anti-tumor activity of BH002 in Chinese patients with advanced solid tumors
Preliminary observation of the therapeutic effect of the drug.
Measured: From first dose to 30 days after last dose
Determination of recommended phase Ⅱ dose (RP2D)
Explore clinically applicable doses and dosage regimens in the next phase.
Measured: 21 days after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start26 Apr 2022
- Primary completion10 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumoursStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhuhai Beihai Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dingwei Ye, PI, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231277
- Sponsor's protocol ID
- BH002-Ⅰ-101
- Other IDs
- CTR20220209
- Acronym
- BH002-Ⅰ-101
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2024
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of Safety, Tolerability and Pharmacokinetics of BH002 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06231277
- Acronym / sponsor ID
- BH002-Ⅰ-101 / BH002-Ⅰ-101
- Conditions
- Solid Tumours
- Keywords
- Phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Zhuhai Beihai Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 30 Jan 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.
The goal of this clinical trial is to about in Patients With Advanced Solid Tumors. The main question[s] it aims to answer are:
- question 1:Evaluating the tolerability of BH002 injection in Chinese patients with advanced solid tumors
- question 2:Obtain the pharmacokinetic (PK) characteristics of BH002 injection in Chinese patients with advanced solid tumors
Detailed description
Subjects will be administered BH002 intravenously. It is expected that there will be 2 to 4 dose groups, with 3 to 6 subjects enrolled in each group. The doses from low to high are 15 mg/m2,20 mg/m2,25 mg/m2,30 mg/m2,35 mg/m2. Subjects were injected with BH002 intravenously on the first day of each cycle, once during a 3-week period.
The dose escalation for this trial will be 20mg/m2 as the starting dose. According to the traditional "3+3" dose escalation principle, 3 subjects are planned to be enrolled in each dose group at the same time. Safety, tolerability, and dose-limiting toxicities (DLTs) will be assessed within 21 days of first dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BH002 | Experimental | Drug: BH002Every 21 days constitutes a treatment cycle, and administration begins on the first day of each cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years old, male or female.
- Patients were diagnosed advanced solid tumors by histology or cytology (preferably prostate cancer, gastric cancer, non-small cell lung cancer, breast cancer, esophageal cancer, head and neck squamous cell carcinoma, ovarian cancer, liposarcoma, etc.) whose disease progresses after standard treatment.
- ECOG score 0~2, expected survival time ≥3 months.
- Have adequate hematology and organ function, and meet the following conditions based on laboratory test results within 7 days before the first dose:1)For those who have not received blood transfusions, blood products or blood cytokines such as granulocyte colony-stimulating factor (G-CSF) within 14 days of the first dose, blood routine: neutrophil count ≥2.0×109/L, platelet count ≥100×109 /L, white blood cell count ≥4.0×109/L, hemoglobin concentration ≥8.0g/dL. 2)Blood biochemistry: liver function: aspartate aminotransferase and alanine aminotransferase ≤1.5 times the upper limit of normal (ULN), total bilirubin ≤ULN. kidney function: creatinine ≤1.5×ULN.
- Baseline left ventricular ejection fraction determined by echocardiography ≥50%, normal or abnormal 12-lead electrocardiogram without clinical significance, QTc interval <450ms (men) or <470ms (women), and no symptoms or signs of heart failure.
Key exclusion criteria (16 listed)
- Those who have received cabazitaxel in the past.
- Those who are severely allergic to cabazitaxel, human albumin, or alcohol.
- Currently receiving other anti-tumor therapys.
- Patients receiving systemic therapy with glucocorticoids (>10 mg/d prednisone or equivalent dose of steroids) or other immunosuppressants within 14 days before the first dose. In the absence of active autoimmune disease, inhaled or topical glucocorticoids can be used, and hormone replacement therapy doses ≤10 mg/d prednisone equivalent are allowed.
- Those who need to use strong inhibitors or inducers of CYP3A4 within 14 days of the first dose and during the study.
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 |
|---|---|---|
| BH002Every 21 days constitutes a treatment cycle, and administration begins on the first day of each cycle | Drug | BH002 |
Primary outcome
Evaluating the tolerability of BH002 in Chinese patients with advanced solid tumors.
Time frame: 21 days after first dose
dose-limiting toxicity [DLT]
Evaluating the tolerability of BH002 in Chinese patients with advanced solid tumors.
Time frame: 21 days after first dose
maximum tolerated dose [MTD]
Obtain the pharmacokinetic characteristics of BH002 in Chinese patients with advanced solid tumors.
Time frame: 216 hours after first dose
Maximum Plasma Concentration [Cmax], etc,
3 secondary outcomes
To evaluate the safety of BH002 in Chinese patients with advanced solid tumors.
Time frame: From first dose to 30 days after last dose
Evaluating the preliminary anti-tumor activity of BH002 in Chinese patients with advanced solid tumors
Time frame: From first dose to 30 days after last dose
Determination of recommended phase Ⅱ dose (RP2D)
Time frame: 21 days after first dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Solid Tumours
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
Dingwei Ye, PI principal investigator
Fudan University
2 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 BH002 in people with Solid Tumours, run by Zhuhai Beihai Biotech Co., Ltd at 2 sites 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 16 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 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Evaluating the tolerability of BH002 in Chinese patients with advanced solid tumors. (time frame: 21 days after first dose). 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 30 Jan 2024.