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Clinical Trial Finder

Search Results

HBM4003 Combine With Toripalimab in Patients With Advanced NEN and Other Solid Tumors Study

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. 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. 2. Patients for Part 1: patients histopathologically diagnosed with advanced or recurrent solid tumors. 3. For arm A and B of Part 2 in the study, Patients with non- functional metastatic neuroendocrine tumor confirmed by histopathology. 4. For arm F of Part 2 in the study, Patients with metastatic colorectal adenocarcinoma diagnosed by histopathology. 5. Patients must be able to provide archived tumor tissues after latest treatment or fresh tumor tissues and relevant pathology report. 6. Patients whose estimated survival time is more than 3 months. 7. 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. 8. Patients with Eastern Cooperative Oncology Group(ECOG) performance status score ≤1. 9. 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. 10. Willing and able to comply with study-specified visits schedule, treatment plan, laboratory examination and other study procedures.

Exclusion Criteria:

1. Patients who are simultaneously participating in another clinical study. 2. 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 Tislelizumab or its excipients. 3. 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.
4. Insufficient recovery from previous treatments. 5. 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. 6. A history of other malignant diseases within 5 years before the first dose. 7. Symptomatic, active, or urgent treatment-requiring central nervous system (CNS) metastasis with imaging evidence (based on CT or MRI assessment). 8. Subjects with pleural effusion, pericardial effusion, or ascites that could not be stabilized by repeated drainage or other methods were determined by investigator. 9. 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.). 10. 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05167071
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Harbour BioMed (Guangzhou) Co. Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Lin Shen, Ph.D
Principal Investigator Affiliation Peking University Cancer Hospital & Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Solid Tumors, Neuroendocrine Tumors, CRC
Additional Details

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.

Arms & Interventions

Arms

Experimental: HBM4003(dose 1) and Toripalimab

Arm A: HBM4003(dose 1) combined with Toripalimab in patients with advanced NEN

Experimental: HBM4003(dose 2) and Toripalimab

Arm B: HBM4003(dose 2) combined with Toripalimab in patients with advanced NEN

Experimental: HBM4003 and Tislelizumab

Arm F: HBM4003(dose 1) combined with Tislelizumab in patients with advanced CRC

Interventions

Drug: - HBM4003

Subjects will be treated with HBM4003 on Day 1 during each 21-day cycle.

Drug: - Toripalimab

Subjects will be treated with Toripalimab on Day 1 during each 21-day cycle.

Drug: - Tislelizumab

Subjects will be treated with Tislelizumab on Day 1 during each 21-day cycle.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing Cancer Hospital, Beijing, China

Status

Address

Beijing Cancer Hospital

Beijing, ,

Nearest Location


Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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