Status:
UNKNOWN
A Study to Evaluate Safety, Tolerability, PK/PD and Preliminary Efficacy of HBM4003 Combined With Anti-PD-1 Antibody
Lead Sponsor:
Harbour BioMed (Guangzhou) Co. Ltd.
Conditions:
Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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 preliminar...
Detailed Description
subjects will be treated with HBM4003 in combination with pembrolizumab for up to 2 years or until confirmed disease progression, unacceptable tolerability or treatment discontinuation through withdra...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2023
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04866485
Start Date
June 14 2021
End Date
February 1 2023
Last Update
April 29 2021
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