Status:
UNKNOWN
Study Investigating Safety,Tolerability,Pharmacokinetics and Antitumor Activities of HBM4003 Combine With Toripalimab
Lead Sponsor:
Harbour BioMed (Guangzhou) Co. Ltd.
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
HBM4003 in combination with Toripalimab. The expected duration of treatment for each subject will vary according to the number of cycles completed; the number of cycles will depend on whether the subj...
Detailed Description
An open-label Phase 1 study to evaluate the safety, tolerability, PK/PD and preliminary efficacy of HBM4003 combined with toripalimab in patients with advanced melanoma and other solid tumors. The st...
Eligibility Criteria
Inclusion
- Main inclusion/exclusion criteria:
- Main 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.
- For Part 1 of the study, patients histopathologically diagnosed with advanced or recurrent solid tumors
- For Part 2 of the study, patients with locally advanced or metastatic melanoma who had been pathologically confirmed and could not be surgically removed were enrolled.
- Subjects must be able to provide fresh or archived tumor tissues .
- 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).
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1.
- Patients whose organ function must meet the study requirements:
- Every woman or man with potential fertility needs to use an effective contraceptive method.
- Main exclusion criteria
- Patients who are simultaneously participating in another clinical study, unless the study is an observational (non-interventional) clinical study or the patient is already in the survival follow-up period of the interventional 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 excipients or toripalimab excipients.
- Previous and concomitant drugs or treatments to be excluded like CTLA4, PD-1,PD-L1.
- Insufficient recovery from previous treatments:
- Diseases that may affect the efficacy and safety of the investigational product.
- 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
- Subjects 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.
Exclusion
Key Trial Info
Start Date :
February 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04727164
Start Date
February 28 2021
End Date
November 1 2023
Last Update
January 29 2021
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