- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05167071
HBM4003 Combine With Toripalimab in Patients With Advanced NEN and Other Solid Tumors Study
January 12, 2022 updated by: Harbour BioMed (Guangzhou) Co. Ltd.
An Open-Label, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, PK/PD and Preliminary Efficacy of HBM4003 in Combination With Toripalimab in Patients With Advanced NEN and Other Solid Tumors
To select RP2D/MTD of HBM4003 in combination with Toripalimab in dose confirmation part(Part 1) and use the RP2D in dose expansion part (Part 2) to evaluate the safety, tolerability, PK/PD and preliminary efficacy of in patients with advanced NEN and other solid tumors
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Subjects will be treated with HBM4003 in combination with Toripalimab for up to 2 years or until confirmed disease progression, unacceptable tolerability or treatment discontinuation through withdrawal of consent occurs, whichever happens first.
This trial consists of:
- A screening period: 28 days
- A treatment period: no longer than 2 years (Part 1 dose escalation study or Part 2 dose expansion)
- A post-treatment follow-up period, including 28 days and 84 days after the last dose of study drug;
- Survival follow-up.
Study Type
Interventional
Enrollment (Anticipated)
61
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: Di Yang, Bachelor
- Phone Number: +86 15810330409
- Email: di.yang@harbourbiomed.com
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males or females aged ≥ 18 years at the time of signing the informed consent form. For Part 1 of this study, the subjects should be ≤ 75 years of age.
- Patients for Part 1: patients histopathologically diagnosed with advanced or recurrent solid tumors.
- For Part 2 of the study, Patients with non- functional metastatic neuroendocrine tumor confirmed by histopathology.
- Patients must be able to provide archived tumor tissues after latest treatment or fresh tumor tissues and relevant pathology report.
- Patients whose estimated survival time is more than 3 months.
- Patients with at least one measurable lesion at baseline according to RECIST (Version 1.1). The lesion had not previously received surgery, radiotherapy and/or local treatment.
- Patients with Eastern Cooperative Oncology Group(ECOG) performance status score ≤1.
- Every woman or man with potential fertility needs to use an effective contraceptive method during the study, up to within 3 months after last drug administration.
- Willing and able to comply with study-specified visits schedule, treatment plan, laboratory examination and other study procedures.
Exclusion Criteria:
- Patients who are simultaneously participating in another clinical study.
- Patients with a history of severe allergic diseases, a history of severe drug allergies, and known or suspected allergy to macromolecular protein preparations or HBM4003 or Toripalimab or its excipients.
Previous and concomitant drugs or treatments to be excluded like:
- Anti-CTLA4 drug;
- For part 1, anti-PD1 anti-PDL1 or anti-PDL2 treatment was received within 8 weeks prior to the start of the study;
- For part 2, patients received anti-PD1, anti-PDL1 or anti-PDL2 treatment during the relapse or metastasis stage, and the time from the last treatment is short than 12 months before the first dose;
- Received other antitumor treatment (including chemotherapy, radiation, targeted therapy, or biotherapy), antitumor vaccine, chinese herbal medicine or proprietary medicine with anti-tumor effect, Immunosuppressant or glucocorticoid, Transfusion of PLT or RBC prior to initiation of study treatment;
- live attenuated vaccine was received before study administration or planned during the study period.
- Insufficient recovery from previous treatments.
- Diseases that may affect the efficacy and safety of the investigational product, including but not limited to active infection, active autoimmune disease or autoimmune disease, primary immunodeficiency disease, any clinically significant cardiovascular disease, severe pulmonary insufficiency, organ transplantation, etc.
- A history of other malignant diseases within 5 years before the first dose.
- Symptomatic, active, or urgent treatment-requiring central nervous system (CNS) metastasis with imaging evidence (based on CT or MRI assessment).
- Subjects with pleural effusion, pericardial effusion, or ascites that could not be stabilized by repeated drainage or other methods were determined by investigator.
- Patients who the investigator believes may have other factors that will affect the efficacy or safety evaluation of this study (e.g., mental disorders, alcoholism, drug use, etc.).
- Women who are pregnant or breastfeeding, or who plan to become pregnant during the study period and within 3 months after the last administration of the investigational product.
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: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HBM4003 and Toripalimab
HBM4003 combined with Toripalimab in patients with advanced NEN and other solid tumors
|
Subjects will be treated with HBM4003 on Day 1 during each 21-day cycle.
Subjects will be treated with Toripalimab on Day 1 during each 21-day cycle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Part 1: DLT
Time Frame: approximate 21 days
|
Number of subjects with DLT in each dose cohort within 1 cycle (21 days) after the first drug administration
|
approximate 21 days
|
Part 1: MTD
Time Frame: approximate 21 days
|
The maximum tolerated dose (MTD) of HBM4003 combined with Toripalimab
|
approximate 21 days
|
Part 1: RP2D
Time Frame: approximate 21 days
|
The recommended phase 2 dose (RP2D) of HBM4003 combined with Toripalimab
|
approximate 21 days
|
Part 2: ORR
Time Frame: maximum 2 years
|
Proportion of subjects with complete response (CR) and partial response (PR)
|
maximum 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lin Shen, Ph.D, Peking University Cancer Hospital & Institute
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 (Anticipated)
January 20, 2022
Primary Completion (Anticipated)
October 17, 2023
Study Completion (Anticipated)
June 3, 2024
Study Registration Dates
First Submitted
December 8, 2021
First Submitted That Met QC Criteria
December 8, 2021
First Posted (Actual)
December 22, 2021
Study Record Updates
Last Update Posted (Actual)
January 18, 2022
Last Update Submitted That Met QC Criteria
January 12, 2022
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4003.6
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.
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