Clinical trial NCT06210815: A Study of HLX42 in Advanced/Metastatic Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2024-01-18
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is an open-label first-in-human phase I clinical study to evaluate the safety and tolerability of HLX42.

Detailed description: This study is an open-label first-in-human phase I clinical study to evaluate the safety and tolerability of HLX42 with escalated doses in the treatment of patients with advanced/metastatic solid tumors. In this study, a 3 + 3 dose escalation method will be adopted, and the patients will be administered with HLX42 at different doses via intravenous infusion. The DLT observation period lasts for 3 weeks after the first administration of HLX42.

Eligibility criteria: Inclusion Criteria:

1. Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the ICF; voluntarily participate in the study; be able to complete the study as per protocol requirements;
2. ≥ 18 years and ≤ 75 years at the time of signing the ICF, male or female;
3. 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;
4. At least one measurable lesion as per RECIST 1.1；
5. An ECOG performance status score of 0-1；
6. Life expectancy \> 3 months;
7. Subjects should agree to provide archived tumor tissue specimens or agree to undergo a biopsy to collect tumor tissue for biomarker testing;
8. Adequate organ functions as confirmed by laboratory tests within 7 days prior to the first administration of the investigational product;
9. For patients with hepatocellular carcinoma, Child-Pugh score must be A;
10. Male and female subjects with child-bearing potential must agree to use at least one highly effective contraception method during the study and within at least 6 months after the last administration of the investigational product; female subjects of childbearing age must have a negative pregnancy test within 7 days prior to enrollment.

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

Primary outcomes:
measure: The Dose-Limiting Toxicity (DLT) of HLX42 within 21 days after the first Administration
timeFrame: From first dose to the end of Cycle 1 (each cycle is 3 weeks).
measure: The maximum tolerated dose (MTD) of HLX42
timeFrame: From first dose to the end of Cycle 1 (each cycle is 3 weeks)
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: approximately up to 24 months
measure: Duration of response (DOR)
timeFrame: approximately up to 24 months.
measure: Progression-free survival (PFS)
timeFrame: up to approximately up to 24 months
measure: Overall survival (OS)
timeFrame: approximately up to 24 months
measure: Cmax
timeFrame: Up to 21 days after the first dose
measure: Tmax
timeFrame: Up to 21 days after the first dose
measure: T1/2
timeFrame: Up to 21 days after the first dose
measure: ADA (anti-drug antibody)
timeFrame: approximately up to 24 months
measure: Nab (neutralizing antibody)
timeFrame: approximately up to 24 months
measure: Number of subjects experiencing adverse events
timeFrame: Day 1 through 90 days after last dose.
Other outcomes:
Locations:
city: Guangdong
country: China
facility: Guangdong Provincial People's Hospital
state: Guangzhou
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Yilong Wu, Dr.
role: PRINCIPAL_INVESTIGATOR
References: