Solid Tumor Clinical Trial
Official title:
An Open-Label, Phase 1 Clinical Study to Evaluate the Safety, Tolerability, PK/PD and Preliminary Efficacy of HBM4003 in Combination With Anti-PD-1 Monoclonal Antibody in Patients With Advanced NSCLC and Other Solid Tumors
This is an open-label, multi-center phase 1 study. The trial, consisting of Part 1a dose confirmation and Part 1b dose expansion, is designed to evaluate the safety, tolerability, PK/PD and preliminary efficacy of HBM4003 in combination with pembrolizumab in patients with advanced NSCLC and other solid tumors.
Status | Not yet recruiting |
Enrollment | 66 |
Est. completion date | February 2023 |
Est. primary completion date | February 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Male or female patients =18 years old at the time of signing the informed consent and = 75 years old at the time of enrollment. - Patients for Part 1a: patients diagnosed with advanced or recurrent solid tumors. - Patients for Part 1b: patients diagnosed with metastatic NSCLC and confirmed with negative tumor PD-L1 expression (TPS<1%). - Patients for Part 1b dose expansion study: have never received systemic therapies as primary therapy for advanced or metastatic diseases. - Patients must be able to provide fresh tumor tissues 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. - Males or females with childbearing potential need to use an effective contraceptive method. - Willing and able to comply with study-specified visits schedule, treatment plan, laboratory examination and other study procedures. Exclusion Criteria: - NSCLC patients with EGFR-sensitive mutations or an ALK translocation based on diagnosis results. - 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 medical history of severe allergic diseases, a history of severe drug allergies, and are known or suspected allergy to macromolecular protein preparations or HBM4003 or pembrolizumab excipients. - Previous and concomitant drugs or treatments to be excluded like CTLA4, PD-1,PD-L1. - Insufficient completely 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. - Active brain metastasis or leptomeningeal metastasis during screening or previous with imaging evidence (based on CT or MRI assessment). - Patients who have received palliative radiotherapy for non-central nervous system lesions within 2 weeks before the first dose. - Patients who have received more than 30 Gy of lung radiation therapy within 6 months before the first dose. - A history of interstitial lung disease or non-infectious pneumonia. - Patients with pleural effusion, pericardial effusion, or ascites. - Patients that may have other conditions that affect the efficacy or safety evaluation of this study (such as mental disorder, alcoholism, drug abuse, etc.) . - Women who are pregnant or breastfeeding, or who plan to become pregnant during the study period and within 3 months after the last dose of study drug. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Harbour BioMed (Guangzhou) Co. Ltd. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Part 1a: Number of subjects with DLT in each dose group within 1 cycles (21 days) after the first drug administration | DLT observation period was defined as one treatment cycles with a total of 21 days | approximate 21 days | |
Primary | Part 1b: ORR | Proportion of subjects with complete response (CR) and partial response (PR) | maximum 2 years | |
Secondary | Part 1a: ORR | including proportions of subjects with complete response (CR) and partial response (PR) | maximum 2 years | |
Secondary | Part 1a: Disease Control Rate, DCR | including proportion of subjects with complete response (CR) and partial response (PR) and stable disease (SD) | maximum 2 years | |
Secondary | Part 1a: Duration of Response, DOR | Calculate the duration from the first confirmed CR or PR to the date of disease progression or death (for any reason) | maximum 2 years | |
Secondary | Part 1a: Duration of Disease Control, DDC | For subjects with Cr, PR or SD, the duration from the time of initial administration to the date of disease progression or death (for any reason) was calculated | maximum 2 years | |
Secondary | Cmax | Peak Plasma Concentration | maximum 2 years | |
Secondary | Tmax | Time to reach maximum serum concentration | maximum 2 years | |
Secondary | AUC0-last | Area under the plasma concentration versus time curve from time zero to last | maximum 2 years | |
Secondary | AUC0-tau | Area under the serum concentration versus time curve from time zero to the dosing interval tau | maximum 2 years | |
Secondary | UC0-inf | Area under the serum concentration versus time curve from time zero to infinity | maximum 2 years | |
Secondary | Vss | Volume of distribution at steady state | maximum 2 years | |
Secondary | CL | Clearance | maximum 2 years | |
Secondary | t1/2 | Terminal half-life | maximum 2 years | |
Secondary | Part 1a: Immunogenicity of HBM4003 and pembrolizumab | including the occurrence of positive anti-drug antibodies (ADA). The occurrence of neutralizing antibodies for subjects with positive ADA | maximum 2 years | |
Secondary | Part 1b: Number of subjects experiencing at least one treatment-related AE | Evaluate safety | maximum 2 years | |
Secondary | Part 1b: DCR | including proportion of subjects with CR, PR and SD | maximum 2 years | |
Secondary | Part 1b: DOR | calculate the duration from the first confirmed CR or PR to the date of disease progression or (for any reason) death. | maximum 2 years | |
Secondary | Part 1b: DDC | for subjects with CR, PR or SD, calculate the duration from the time of initial medication to the day of disease progression or (for any reason) death | maximum 2 years | |
Secondary | Part 1b: Overall survival (OS) | the length of time from the start of treatment to the death of the subject (for any reason) | maximum 2 years | |
Secondary | Part 1b: Progression-free survival (PFS) | the length of time from the beginning of treatment to the beginning of disease progression or death (for any reason) | maximum 2 years | |
Secondary | Part 1b: Immunogenicity of HBM4003 and pembrolizumab | including the occurrence of positive anti-drug antibodies (ADA). The occurrence of neutralizing antibodies for subjects with positive ADA. | maximum 2 years |
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