- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05060263
A Study of of HOT1030 in Patients With Advanced Solid Tumors
September 17, 2021 updated by: Huabo Biopharm Co., Ltd.
A Phase 1, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of HOT1030 in Patients With Advanced Solid Tumors
A Phase 1, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of HOT-1030 in Patients with Advanced Solid Tumors
Study Overview
Detailed Description
This study is an open-label, Phase 1, study to evaluate the safety, tolerability, PK, and PD profiles of HOT-1030 as a monotherapy to assess the maximum tolerated dose (MTD) in subjects with advanced solid tumors.
Study Type
Interventional
Enrollment (Anticipated)
42
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: yang yongming, Doctor
- Phone Number: +86 18964167352
- Email: yongmin.yang@huaota.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China
- Recruiting
- Shanghai Huaota Biopharmaceutical Co., Ltd.
-
Contact:
- Yang yongming, doctor
- Phone Number: 18964167352
- Email: 杨永民<yongmin.yang@huaota.com>
-
Principal Investigator:
- Han Baohui, doctor
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female from 18 to 75 yrs (include 18 yrs and 75 yrs).
- 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.
- Patients with histologically or cytologically confirmed advanced malignant solid tumor who have received or been intolerant of all standard therapies thought to confer clinical benefit.
- Measurable disease on imaging base on RECIST v1.1 for solid tumors;
- Stop anticancer therapy for more than 5 half-lives or 4 weeks (whichever is shorter) prior to study entry;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Adequate organ function, as indicated by the laboratory values.
- Female patients of childbearing potential must have a negative serum pregnancy test at screening; Male patients and the female patients of childbearing potential must agree to use highly effective contraceptive measures throughout the study starting with the Screening Visit through 90 days after the last dose of study treatment is received.
- Life expectancy >3 months.
Exclusion Criteria:
- Received any anti-CD137 antibodies.
- Active primary CNS tumor or metastatic CNS tumor (expect the patients who had received the treatment and stopped the treatment for more than 4 weeks before first dose), active epilepsy, Spinal cord compression or Cancerous meningitis.
- Active autoimmune disease or history of autoimmune disease requiring systemic therapy < 2 years prior to screening except hypothyroidism, vitiligo, Grave's disease, Hashimoto's disease, or Type I diabetes. Patients with childhood asthma or atopy that has not been active in the 2 years prior to study screening are eligible.
- Require systematic anti-infective therapy a week before first dose because of active infection.
- Taken the surgical operations not related to the research 4 weeks before first dose
Used of systemic corticosteroids (a dose equivalent > 10 mg/day of prednisone or )or other immunosuppressive agents, excepted:
- Patients are allowed to have topical use or inhaled glucocorticoid.
- Patients are allowed to have a less than seven-day glucocorticoid treatment preventing or treat non-autoimmune allergic diseases.
- The toxicity of previous anti-tumor therapy has not recovered (defined as not recovering to grade 0 or 1, except for alopecia) or has not fully recovered from previous surgery.
- During the 6 months prior to screening, the patient had a history of major cardiovascular and cerebrovascular events, such as myocardial infarction, coronary angioplasty or bypass surgery, heart valve repair, unstable arrhythmias, unstable angina, transient ischemic attack, or cerebrovascular accidents.
- New York Heart Association (NYHA) grade III or IV congestive heart failure.
- Patients with uncontrolled hypertension (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg at the time of screening) who had been on a stable dose of antihypertensive drugs for at least 4 weeks at the time of screening).
- Active hepatitis B (hepatitis B virus titer >103 copies /ml or 200IU/ml); Hepatitis C virus infection (HCV-RNA above the detection limit); Prophylaxis antiviral therapy other than interferon is allowed. In patients with advanced liver cancer (HCC), hepatitis B virus titer >104 copies /ml or 2000IU/ml should be excluded.
- A history of known congenital and acquired immunodeficiency, including positive HIV antibody tests.
- Patients with a known history of severe allergic reactions to macromolecular protein formulations/monoclonal antibodies or to any investigational drug component (CTCAE V5.0 grade greater than 3).
- Participated in clinical trials of other drugs within 4 weeks before the first administration.
- Pregnant or lactating women or women at risk of pregnancy have a positive pregnancy test before the first medication.
- Other investigators consider that the patient has any clinical or laboratory abnormality that makes him unsuitable for participation in this clinical study.
- prior history of a clear neurological or psychiatric disorder, including epilepsy or dementia.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1
HOT-1030, every 21 days by intravenous administration.
HOT-1030 is a recombinant humanized CD137 monoclonal antibody injection.
|
HOT-1030 is a Recombinant Humanized CD137 Monoclonal Antibody Injection
Other Names:
|
Experimental: Cohort 2
HOT-1030, every 21 days by intravenous administration.
HOT-1030 is a recombinant humanized CD137 monoclonal antibody injection.
|
HOT-1030 is a Recombinant Humanized CD137 Monoclonal Antibody Injection
Other Names:
|
Experimental: Cohort 3
HOT-1030, every 21 days by intravenous administration.
HOT-1030 is a recombinant humanized CD137 monoclonal antibody injection.
|
HOT-1030 is a Recombinant Humanized CD137 Monoclonal Antibody Injection
Other Names:
|
Experimental: Cohort 4
HOT-1030, every 21 days by intravenous administration.
HOT-1030 is a recombinant humanized CD137 monoclonal antibody injection.
|
HOT-1030 is a Recombinant Humanized CD137 Monoclonal Antibody Injection
Other Names:
|
Experimental: Cohort 5
HOT-1030, every 21 days by intravenous administration.
HOT-1030 is a recombinant humanized CD137 monoclonal antibody injection.
|
HOT-1030 is a Recombinant Humanized CD137 Monoclonal Antibody Injection
Other Names:
|
Experimental: Cohort 6
HOT-1030, every 21 days by intravenous administration.
HOT-1030 is a recombinant humanized CD137 monoclonal antibody injection.
|
HOT-1030 is a Recombinant Humanized CD137 Monoclonal Antibody Injection
Other Names:
|
Experimental: Cohort 7
HOT-1030, every 21 days by intravenous administration.
HOT-1030 is a recombinant humanized CD137 monoclonal antibody injection.
|
HOT-1030 is a Recombinant Humanized CD137 Monoclonal Antibody Injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability as measured by incidence of AEs (Adverse Events)
Time Frame: through study completion, an average of 1 year
|
Incidence and severity of AEs, Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under Curve (AUC) of HOT-1030
Time Frame: 42 days
|
Area under the concentration-time curve of HOT-1030 in plasma over the time interval from 0 extrapolated to infinity
|
42 days
|
Maximum Serum Concentration (Cmax) of HOT-1030
Time Frame: 42 days
|
Maximum Serum Concentration (Cmax) in plasma
|
42 days
|
Antitumor Activity of HOT-1030 in Patients With advanced Solid Tumors
Time Frame: through study completion, an average of 1 year
|
Response is defined as a Complete Response + Partial Response and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Han Baohui, Doctor, Shanghai Chest Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 12, 2021
Primary Completion (Anticipated)
June 30, 2023
Study Completion (Anticipated)
June 30, 2023
Study Registration Dates
First Submitted
March 26, 2021
First Submitted That Met QC Criteria
September 17, 2021
First Posted (Actual)
September 29, 2021
Study Record Updates
Last Update Posted (Actual)
September 29, 2021
Last Update Submitted That Met QC Criteria
September 17, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HOT-1030-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Solid Tumor, Adult
-
Memorial Sloan Kettering Cancer CenterRecruitingSolid Tumor | Solid Tumor, Adult | Solid Tumor, Unspecified, AdultUnited States
-
Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterRecruitingSolid Tumor | Solid Tumor, Adult | Solid Tumor, Unspecified, AdultUnited States, Puerto Rico
-
Memorial Sloan Kettering Cancer CenterLincoln Medical and Mental Health CenterRecruitingSolid Tumor | Solid Tumor, Adult | Solid Tumor, Unspecified, AdultUnited States, Puerto Rico
-
Shenzhen Ionova Life Sciences Co., Ltd.Merck Sharp & Dohme LLCRecruitingCancer | Solid Tumor, Adult | Solid Carcinoma | Solid Tumor, Unspecified, Adult | Cancer Metastatic | Tumor, SolidUnited States
-
TOLREMO therapeutics AGRecruitingCancer | Adult Solid Tumor | Advanced Solid Tumor | Adult DiseaseSpain, Switzerland
-
Partner Therapeutics, Inc.WithdrawnSolid Tumor | Solid Tumor, AdultUnited States
-
Invitae CorporationRecruitingCancer | Solid Tumor | Solid Tumor, AdultUnited States
-
Sairopa B.V.RecruitingMetastatic Solid Tumor | Solid Tumor, Adult | Refractory CancerUnited States, Moldova, Republic of
-
Institut CurieRecruitingChemotherapy Effect | Solid Tumor, Adult | Solid Tumor, ChildhoodFrance
-
New York Stem Cell Foundation Research InstituteStevens Institute of TechnologyRecruiting
Clinical Trials on HOT-1030
-
University of ArizonaCompletedInflammation | Aging | Depression, AnxietyUnited States
-
Seyma ErtugralCompletedBreast Pumping | Breast Milk Collection | Massage TherapyTurkey
-
Riphah International UniversityNot yet recruiting
-
Indiana UniversityJohn D. Dingell VA Medical Center; White River Junction Veterans Affairs Medical...CompletedColon Cancer | Colon Adenoma | Colon PolypUnited States
-
Ivano-Frankivsk National Medical UniversityCompletedCovid19 | Myalgia | Cough | Fever | Anosmia | Nasal Congestion | NasopharyngitisUkraine
-
Coventry UniversityCompleted
-
Bo-In LeeSt Vincent's Hospital; Incheon St.Mary's HospitalCompletedPolyp of Large IntestineKorea, Republic of
-
Postgraduate Institute of Medical Education and...CompletedLung Cancer | Endobronchial GrowthIndia
-
China Medical University HospitalNot yet recruiting
-
State University of New York at BuffaloCompletedFatigue | Heat StressUnited States