solid tumor

This study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of humanized anti-EGFR monoclonal antibody, HLX07, in patients with epithelial cancer who have failed standard therapy and deemed unamenable by conventional therapy. This study will also evaluate the pharmacokinetics, pharmacodynamics, immunogenicity and anti-tumor effect of HLX07 and explore the potential prognostic and predictive biomarkers.

HLX07

anti-EGFR humanized monoclonal antibody

solution

100mg/5mL

Primary Outcome Measures :
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 1 year ]

Secondary Outcome Measures :
Number of participants with treatment-related pathological Complete Response assessed using RECIST 1.1 criteria. [ Time Frame: 1 year ]
Patients will receive CT/MRI imaging studies every 8 weeks for treatment response until disease progression, withdrawal from the study or death, whichever occurs first.

Inclusion Criteria:

Histologically-confirmed, unidimensionally-measurable and/or evaluable carcinoma which has failed standard therapy or for whom no standard therapy is available.
ECOG performance status score of ≤ 2 at study entry.
Able to provide written informed consent.
White blood cell (WBC) count ≥3 x 109/L;an absolute neutrophil count ≥ 1.5 x 109/L;a hemoglobin level > 90 g/L; and a platelet count ≥ 100 x 109/L.
Adequate hepatic function as defined by: alkaline phosphatase level ≤ 5.0 x the ULN, bilirubin level ≤ 1.5 x the ULN, aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤ 2.5 x the ULN or ≤ 5 x the ULN for patients with liver metastases
Adequate renal function as defined by a serum creatinine level within normal limits.
Use of effective contraception if procreative potential exists.
Life expectancy of approximately 3 months or longer in the opinion of the investigator.

Exclusion Criteria:

Chemotherapy, radiation, and/or hormonal therapy (except palliative radiation therapy for disease-related pain and chronic hormonal therapy for prostate carcinoma) within 4 weeks of study entry.
Concurrent unstable or uncontrolled medical disease (e.g., active uncontrolled systemic infection, poorly controlled hypertension or history of poor compliance with an anti-hypertensive regimen, unstable angina, congestive heart failure, uncontrolled diabetes) or other chronic disease, which, in the opinion of the investigator, could compromise the patient or the study.
Newly-diagnosed or symptomatic brain metastases (patients with a history of brain metastases must have received definitive surgery or radiotherapy, be clinically stable, and not taking steroids; anticonvulsants are allowed).
Any concurrent malignancy other than basal cell carcinoma or carcinoma in situ of the cervix. Patients with a previous malignancy but without evidence of disease for more than 3 years will be allowed to enter the trial.
Any condition that prevents the patient from providing informed consent.
Pregnancy (confirmed by serum beta human chorionic gonadotropin [beta-HCG]) or breast-feeding.
Any investigational agent(s) or device(s) within 4 weeks of study entry.
Prior treatment with cetuximab, or any other anti-EGFR monoclonal antibody therapy for less than 3 months. Prior treatment with other monoclonal antibodies targeting receptors other than the EGFR is permitted if the drug has been discontinued more than (include) 4 weeks prior to study entry.
Tumor cells with either K-ras, N-ras or B-raf mutations.
Known history of human immunodeficiency virus infection.
Employees of the investigator or study center with direct involvement in this study or other studies under the direction of the investigator or study center, as well as family members of the employees.