A Study to Evaluate Safety, Tolerability, PK/PD and Preliminary Efficacy of HBM4003 Combined With Anti-PD-1 Antibody

• Status: Not yet recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

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 preliminary efficacy of HBM4003 in combination with pembrolizumab in patients with advanced NSCLC and other solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Harbour BioMed (Guangzhou) Co. Ltd.
• Treatments: Pembrolizumab

Criteria

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.