Evaluating HLX42 for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, first-in-human phase I clinical study designed to assess the safety and tolerability of HLX42 in patients with advanced or metastatic solid tumors. The study employs a 3 + 3 dose escalation method, where participants will receive escalating doses of HLX42 via intravenous infusion. The observation period for dose-limiting toxicities lasts for three weeks following the initial administration of the drug.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female;
2. 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);
3. At least one measurable lesion as per RECIST 1.1；
4. An ECOG performance status score of 0-1；
5. Life expectancy \> 3 months;
6. Adequate organ functions as confirmed by laboratory tests within 7 days prior to the first administration of the investigational product;
7. For patients with hepatocellular carcinoma, Child-Pugh score must be A;

Exclusion Criteria:

1. 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;
2. 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)；
3. History of (non-infectious) ILD requiring the use of steroids, current ILD, or suspected ILD that cannot be ruled out by imaging at screening;
4. Subjects who are allergic to protein preparations/ monoclonal antibodies/ any component in the formulation of the investigational product;
5. Subjects with known previous serious eye disorders;
6. Active systemic infectious diseases requiring intravenous antibiotics within 2 weeks prior to the first administration of the investigational product;
7. Any poorly-controlled cardiovascular and cerebrovascular clinical symptoms or diseases;
8. 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;
9. 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;
10. Patients who have used potent CYP2D6/CYP3A inhibitors or inducers within 2 weeks prior to the first administration;
11. Patients who have history of immunodeficiency, including HIV infection or other acquired or congenital immunodeficiencies, or history of organ transplantation;
12. Patients with active HBV or HCV infection or HBV/HCV co-infection;
13. Pregnant or lactating women;
14. 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.

Where it's running

• Guangdong Provincial People's Hospital
  Guangdong, Guangzhou, China Recruiting

Study contacts

• Principal investigator: Yilong Wu, Dr. — Guangdong Provincial People's Hospital
• Study coordinator: Yilong Wu, Dr.
• Email: syylwu@live.cn
• Phone: 020-83827812

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.