RecruitingPhase 1NCT06210815
A Study of HLX42 in Advanced/Metastatic Solid Tumors
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of HLX42 (Anti-EGFR ADC) in Patients With Advanced/Metastatic Solid Tumors
Sponsor
Shanghai Henlius Biotech
Enrollment
102 participants
Start Date
Mar 14, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
This study is an open-label first-in-human phase I clinical study to evaluate the safety and tolerability of HLX42.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria7
- ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female;
- Patients with histologically or cytologically confirmed advanced/metastatic malignant solid tumors, who are refractory to or intolerable with standard treatment, or for which no standard treatment is available(stage 1); Patients with histologically or cytologically confirmed advanced/metastatic malignant NSCLC, who are refractory to or intolerable with standard treatment, or for which no standard treatment is available(stage 2);
- At least one measurable lesion as per RECIST 1.1；
- An ECOG performance status score of 0-1；
- Life expectancy \> 3 months;
- Adequate organ functions as confirmed by laboratory tests within 7 days prior to the first administration of the investigational product;
- For patients with hepatocellular carcinoma, Child-Pugh score must be A;
Exclusion Criteria14
- History of other malignant tumors within 2 years prior to the first administration, except for cured cervical carcinoma in situ or cutaneous basal cell carcinoma;
- The histopathological type is large cell carcinoma, adenosquamous carcinoma, other types (including but not limited to sarcomatoid carcinoma, lymphoepithelioma-like carcinoma, NUT carcinoma, etc.), or contains neuroendocrine pathological components, etc. (stage 2)；
- History of (non-infectious) ILD requiring the use of steroids, current ILD, or suspected ILD that cannot be ruled out by imaging at screening;
- Subjects who are allergic to protein preparations/ monoclonal antibodies/ any component in the formulation of the investigational product;
- Subjects with known previous serious eye disorders;
- Active systemic infectious diseases requiring intravenous antibiotics within 2 weeks prior to the first administration of the investigational product;
- Any poorly-controlled cardiovascular and cerebrovascular clinical symptoms or diseases;
- Patients who have been assessed as unsuitable for inclusion by the investigator, due to brain metastases, spinal cord compression, or cancerous meningitis with clinical symptoms, or uncontrolled brain or spinal cord metastases that have been evidenced;
- Patients who have received long-term systemic steroids treatment (equivalent to prednisone \> 10 mg/day) or immunosuppressive agents of any other forms, which should be discontinued at least 2 weeks prior to the first infusion of the investigational product;
- Patients who have used potent CYP2D6/CYP3A inhibitors or inducers within 2 weeks prior to the first administration;
- Patients who have history of immunodeficiency, including HIV infection or other acquired or congenital immunodeficiencies, or history of organ transplantation;
- Patients with active HBV or HCV infection or HBV/HCV co-infection;
- Pregnant or lactating women;
- Subjects who are not suitable for participating in this clinical study due to any clinical or laboratory abnormalities or other reasons as assessed by the investigator.
Interventions
DRUGHLX42
HLX42 is an anti-EGFR monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06210815