NCT06210815 A Study of HLX42 in Advanced/Metastatic Solid Tumors
| NCT ID | NCT06210815 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shanghai Henlius Biotech |
| Condition | Solid Tumor and NSCLC |
| Study Type | INTERVENTIONAL |
| Enrollment | 102 participants |
| Start Date | 2024-03-14 |
| Primary Completion | 2026-09-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 102 participants in total. It began in 2024-03-14 with a primary completion date of 2026-09-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is an open-label first-in-human phase I clinical study to evaluate the safety and tolerability of HLX42.
Eligibility Criteria
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.
Contact & Investigator
Yilong Wu, Dr.
PRINCIPAL INVESTIGATOR
Guangdong Provincial People's Hospital
Frequently Asked Questions
Who can join the NCT06210815 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Solid Tumor and NSCLC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06210815 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06210815 currently recruiting?
Yes, NCT06210815 is actively recruiting participants. Contact the research team at syylwu@live.cn for enrollment information.
Where is the NCT06210815 trial being conducted?
This trial is being conducted at Guangdong, China.
Who is sponsoring the NCT06210815 clinical trial?
NCT06210815 is sponsored by Shanghai Henlius Biotech. The principal investigator is Yilong Wu, Dr. at Guangdong Provincial People's Hospital. The trial plans to enroll 102 participants.