Evaluating HLX42 for advanced 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

This study is testing a new drug called HLX42 to see if it's safe and tolerable for people with advanced solid tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 102 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Henlius Biotech (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 1 site (Guangdong, Guangzhou)
• Trial ID: NCT06210815 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with confirmed advanced or metastatic solid tumors that are refractory to standard treatments.

Not a fit: Patients with solid tumors that have effective standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have limited or no effective standard therapies.

How similar studies have performed: While this approach is novel in the context of HLX42, similar studies evaluating new treatments for advanced solid tumors have shown promise in the past.

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.

Where this trial is running

Guangdong, Guangzhou

• 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.

Conditions Solid Tumor and NSCLC