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New treatment option for Solid Tumor and NSCLC
Official title A Study of HLX42 in Advanced/Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06210815
What this study is testing
What is HLX42?
HLX42 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor and nsclc.
Also referred to as Anti-EGFR ADC.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is an open-label first-in-human phase I clinical study to evaluate the safety and tolerability of HLX42.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- ≥ 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...
- At least one measurable lesion as per RECIST 1.1；
- An ECOG performance status score of 0-1；
- Life expectancy \> 3 months;
You likely can't join if
- History of other malignant tumors within 2 years prior to the first administration, except for cured cervical carcinoma in situ or cutaneous basal...
- The histopathological type is large cell carcinoma, adenosquamous carcinoma, other types (including but not limited to sarcomatoid carcinoma...
- History of (non-infectious) ILD requiring the use of steroids, current ILD, or suspected ILD that cannot be ruled out by imaging at screening;
- people who are allergic to protein preparations/ monoclonal antibodies/ any component in the formulation of the investigational product;
- people 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;
See the full eligibility criteria
- ≥ 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)...
- 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;
- 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...
- History of (non-infectious) ILD requiring the use of steroids, current ILD, or suspected ILD that cannot be ruled out by imaging at screening;
- people who are allergic to protein preparations/ monoclonal antibodies/ any component in the formulation of the investigational product;
- people 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...
- 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...
- 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;
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangdong, Guangzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangdong, Guangzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.