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Solid Tumor, AdultPhase 1NCT06232863

A Study of BH009 in Head and Neck Squamous Cell Carcinoma and Ovarian Cancer

A Phase 1 study testing BH009 in people with Solid Tumor, Adult, run by Zhuhai Beihai Biotech Co., Ltd at 5 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study will assess the safety and tolerability and pharmacokinetics of BH009 in patients with advanced head and neck squamous (non-nasopharyngeal) and ovarian cancer. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Solid Tumor, Adult
What is being tested?
BH009
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
5 sitesChina
Study dates
18 Jan 2023to 30 Apr 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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects aged between 18-70 years old at the time of informed consent.
  • Histologically or cytologically proven squamous cell carcinoma of the head and neck(including oropharynx, oral cavity, hypopharynx and larynx, excluding nasopharyngeal carcinoma) and ovarian carcinoma (including epithelial ovarian carcinoma, fallopian tube carcinoma and primary peritoneal carcinoma).
  • Subjects who failed by standard treatments, or refused standard treatments, or the investigator considered the subject unsuitable for standard treatments.
  • At least one measurable lesion according to RECIST 1.1 at baseline.
  • Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Subjects must have an expected survival of at least 3 months.
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  • Subjects must have adequate organ and marrow function. Laboratory results meet the following conditions within 7 days prior to the first dose [subjects must not have received recombinant granulocyte-colony stimulating factor (G-CSF) or blood transfusion within 14 days prior to the first dose]:
  • Hematological : Absolute neutrophil count(ANC)≥1.5×109/L, platelet count(PLT)≥100×109/L, hemoglobin(Hb)≥90 g/L;
  • Renal function :Serum creatinine(Cr)≤1.5×ULN and creatinine Clearance ≥50 mL/min(Cockcroft-Gault );
  • Liver function : Total bilirubin ≤1.5×ULN, alanine aminotransferase(ALT)and aspartate aminotransferase(AST) ≤ 1.5×ULN (if liver tumor/metastases are present, then ≤2.5×ULN is allowed).
  • Subjects with a left ventricular ejection fraction of ≥50% measured by echocardiography at baseline, a normal 12-lead electrocardiogram or no clinically significant abnormalities, QTc intervals <450 ms (men) or <470 ms (women) (Fridericia's), and no signs or symptoms of heart failure.
  • Subjects with remission of toxicity due to prior therapy to ≤ grade 1 (except for toxicities such as alopecia that are not considered a safety risk by investigator).
  • Subjects have not received surgery, chemotherapy, radiotherapy, immunotherapy, biotherapy, targeted therapy, anti-tumour herbs, small molecule targeted drugs, within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose of the drug.
  • Subjects voluntarily signed the informed consent form, had good compliance, were available for follow-up, and voluntarily complied with study regulations.

Who cannot join

  • Subjects with a known hypersensitivity to the study drug and any excipient contained in the drug formulation,or intolerance to paclitaxel analogues.
  • Subjects are currently receiving other anti-tumor therapy.
  • Subjects requiring a potent inhibitor of CYP3A4 within 14 days prior to the first dose and during the study period.
  • Subjects have been treated with systemically administered glucocorticosteroid (prednisone > 10 mg/day or equivalent dose of other similar drug) or other immunosuppressive agents within 14 days prior to the first use of the investigational medicinal product; with the exception of the following: treatment with topical, ophthalmic, intra-articular, intranasal, and inhaled glucocorticosteroids; and short-term prophylactic glucocorticosteroids (e.g., prevention of allergy to contrast media).
  • Subjects with clinically significant psychiatric or central nervous system disorders.
  • Subjects with a primary malignant tumour of the brain; or those who with two or more malignant tumours (except cured non-melanoma skin cancer, cervical cancer, thyroid cancer and intramucosal cancer of the gastrointestinal tract).
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  • Subjects who with serious medical conditions:
  • Subjects with clinically significant cardiovascular disease, including: severe or uncontrolled heart disease requiring treatment, congestive heart failure classified by the New York Heart Association (NYHA) as grade 3 or 4, unstable angina pectoris uncontrolled by medication, history of myocardial infarction within 6 months prior to enrolment, severe arrhythmia requiring medication (except atrial fibrillation or paroxysmal supraventricular tachycardia);
  • Subjects with indwelling cardiac stents within 6 months;
  • Subjects with uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg after pharmacological intervention), diabetes mellitus (glycated haemoglobin HbA1c ≥8.0% or fasting blood glucose ≥10.0 mmol/L), pleural effusion, pericardial effusion, ascites;
  • Subjects have uncontrolled peptic ulcer, or other uncontrolled thromboembolic event;
  • Subjects with interstitial lung disease, pulmonary fibrosis, or a history of pneumonia requiring steroid therapy.
  • Subjects with known HIV, HBV, HCV, and syphilis spirochete infections (hepatitis B surface antigen (HBsAg)-positive with HBV-DNA greater than 1,000 IU/mL; HCV-Ab-positive with a copy number higher than the upper limit of normal on the HCV RNA assay); and uncontrolled active infections (in those requiring systemic anti-infective therapy, or subjects with a temperature of >38°C (axillary temperature) prior to dosing and unable to explain it).
  • Subjects have a history of drug abuse.
  • Pregnant or nursing women; positive pregnancy test within 7 days prior to the first dose in female subjects of childbearing potential; any female subjects of childbearing potential does not consent to use of a medically recognised effective method of contraception throughout the trial period and for 3 months after the the last dose.
  • Subjects who have been participated in other clinical trial within 28 days prior to the first dose (from the date of the last dose).
  • Subjects who have been vaccinated within 28 days prior to the first dose or who will be vaccinated throughout the study (except for inactivated vaccines).
  • Subjects who be unsuitable for inclusion by investigators judgement.

Trial locations and contacts

5 sites in 1 country.

Xiaohua Wei, PM contact

13500248359

xhwei@bayhibiotech.com

Mingyue Zeng, APM contact

15113340590

myzeng@bayhibiotech.com

5 sites in 1 country

China5 sites, 5 recruiting

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui

    YuZhi Li, PI, 13955256571, liyuzhi0518@sina.com

    Huan Zhou, PI, 13665527160, zhouhuanbest@vip.163.com

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan

    Jing Wang, PI, 13875902083, wangjing189@163.com

    Ya Han, PI, 18673176667, hanyaqiancs@163.com

    Recruiting

  • Affiliated Zhongshan Hospital Of Dalian University

    Dalian, Liaoning

    Xiang Li, PI, 18018931093, 94207842@qq.com

    Recruiting

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

    Shuzhong Yao, PI, 13602834127, zsyyyb@mail.sysu.edu.cn

    Recruiting

  • Obstetrics & Gynecology Hospital of Fudan University

    Shanghai, Shanghai Municipality

    Yu Kang, 13636328211, kangyu1489@fckyy.org.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase I Study To Evaluate The Safety, Tolerability and Pharmacokinetics Of BH009 In Patients With Advanced Head And Neck Squamous (Non-nasopharyngeal) And Ovarian Cancer

This study will assess the safety and tolerability and pharmacokinetics of BH009 in patients with advanced head and neck squamous (non-nasopharyngeal) and ovarian cancer.

Read the detailed description

This is a multicenter, open label phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic profile of BH009 in patients with advanced squamous head and neck cancer (non-nasopharyngeal) and ovarian cancer, and to initially explore its clinical effectiveness. This study will use a "3+3" dose escalation design to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of BH009.

Being tested
BH009
Keywords
Phase I

What participants receive

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

  • BH009Drug

    Every 28 days constitutes a treatment cycle, and administration on day 1, day 8, day 15 of each cycle

Study groups in NCT06232863
Study groupRoleWhat they receive
BH009ExperimentalEvery 28 days constitutes a treatment cycle, and administration on day 1, day 8, day 15 of each cycle
Receives: Drug: BH009

What is being measured

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

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    All adverse events (AE) defined by CTCAE version 5.0

    Measured: first dose to 30 days after last dose

  2. Recommended phase 2 dose of BH009

    defined by CTCAE version 5.0

    Measured: first dose to 30 days after last dose

  3. MTD of BH009

    When the dose is incremented beyond the MTD, the previous lower dose group will be identified as the MTD.

    Measured: first dose to 30 days after last dose

Secondary outcomes (11)

  1. Objective response rate

    Objective response rate by RECIST version 1.1

    Measured: After first dose until 30 days after last dose

  2. Duration of relief

    Duration of relief by RECIST version 1.1

    Measured: After first dose until 30 days after last dose

  3. Disease control rate

    Disease control rate by RECIST version 1.1

    Measured: After first dose until 30 days after last dose

  4. Progression-free survival

    Disease control rate by RECIST version 1.1

    Measured: After first dose until 30 days after last dose

  5. PK Analysis of BH009

    Maximum Concentration (Cmax)

    Measured: predose, 30 minutes, 45 minutes, 1 hour after the start of infusion (immediately after the end of infusion), 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, and 48 hours after the end of infusion

  6. PK Analysis of BH009

    Time to Cmax (Tmax)

    Measured: predose, 30 minutes, 45 minutes, 1 hour after the start of infusion (immediately after the end of infusion), 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, and 48 hours after the end of infusion

  7. PK Analysis of BH009

    Area Under the Curve From Time 0 Hours to Last Quantifiable Concentration (AUC0-last)

    Measured: predose, 30 minutes, 45 minutes, 1 hour after the start of infusion (immediately after the end of infusion), 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, and 48 hours after the end of infusion

  8. PK Analysis of BH009

    Area Under the Curve From Time 0 Hours to Infinity (AUC0-inf)

    Measured: predose, 30 minutes, 45 minutes, 1 hour after the start of infusion (immediately after the end of infusion), 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, and 48 hours after the end of infusion

  9. PK Analysis of BH009

    Apparent Terminal Elimination Half-Life (t1/2)

    Measured: predose, 30 minutes, 45 minutes, 1 hour after the start of infusion (immediately after the end of infusion), 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, and 48 hours after the end of infusion

  10. PK Analysis of BH009

    Apparent Total Clearance (CL)

    Measured: predose, 30 minutes, 45 minutes, 1 hour after the start of infusion (immediately after the end of infusion), 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, and 48 hours after the end of infusion

  11. PK Analysis of BH009

    Apparent Volume of Distribution (Vz/F)

    Measured: predose, 30 minutes, 45 minutes, 1 hour after the start of infusion (immediately after the end of infusion), 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, and 48 hours after the end of infusion

Timeline

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

  1. First posted31 Jan 2024
  2. Study start18 Jan 2023
  3. Primary completion30 Mar 2024 (estimated)
  4. Study completion30 Apr 2024 (estimated)

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
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06232863
Sponsor's protocol ID
BH009-I-101
Other IDs
CTR20230004
Status last verified
Jan 2024
First submitted
19 Jan 2024
Last updated
2 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BH009 in people with Solid Tumor, Adult, run by Zhuhai Beihai Biotech Co., Ltd at 5 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 14 inclusion and 18 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 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xiaohua Wei, PM (13500248359, xhwei@bayhibiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: first dose to 30 days after last 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?

On the ClinicalTrials.gov record for NCT06232863.

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 2 Feb 2024.

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