Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: A Phase I Study of Epitinib(HMPL-813) in Patients With Advanced Solid Tumors

Summary: Epitinib (HMPL-813) is a selective EGFR tyrosine kinase inhibitor. Epitinib has demonstrated strong inhibitory effects on multiple tumors with overexpressed EGFR or sensitive EGFR mutations in pre-clinical setting. This first-in-human study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity(DLT), safety and tolerability, pharmacokinetics (PK), and preliminary anti-tumor activity of Epitinib.


Eligibility: Inclusion Criteria:
  -  Histopathology confirmed solid tumors
  -  Failed to standard treatment or no standard treatments for uncontrolled, recurrent and/or metastatic advance tumor (whatever previous surgery conditions)
  -  Age 18-70
  -  ECOG 0-2, and no worse within 7days
  -  Life expected > 12 weeks
  -  written informed consent form voluntarily
  -  For dose expansion cohort, subjects must be eligible for the following inclusion criteria:
  -  EGFR sensitizing mutation in exon 19 deletion or exon 21(L858R).
  -  Histologically or cytologically confirmed advanced NSCLC with brain metastasis. No prior brain radiotherapy or brain metastasis progressed after brain radiotherapy delivered assessed by RECIST 1.1.
  -  No prior EGFR-TKI treatment. Or subjects who treated with EGFR-TKI developed brain lesions during EGFR-TKI therapy or the existing brain lesions progressed but with stable extra-cranial lesions.
  -  Treatment failure of prior systemic chemotherapy for locally advanced or metastasized NSCLC or intolerance to chemotherapy. Or subjects with disease relapse after treated with adjuvant or neo-adjuvant chemotherapy.
  -  With at least one measurable disease ( RECIST 1.1).
  Exclusion Criteria:
  -  Lab testing within 2 weeks before enrolled, AND ANC<1.5×10 9/L, platelet<75×10 9/L, or Hb<9g/dL,
  -  Serum Total Bilirubins > ULN, ALT/AST≥ULN without liver metastasis, or ALT/AST≥2.5ULN with liver metastasis
  -  Serum creatinine >1.5ULN or creatinine clearance <40ml/min
  -  Diastolic systolic pressure≥140mmHg or systolic diastolic pressure≥90mmHg whatever anti-hypertension drug used,
  -  Serum potassium <4.0mmol/L(whenever potassium implemented), serum calcium(ionic or albumin-type calcium) or serum magnesium outside normal ranges(whenever implemented)
  -  Within previous 4 weeks treated by systemic anti-tumor therapy, or radiotherapy, immune therapy, biological or hormonal therapy, and clinical trials.
  -  Unrecovered from any previous therapy related toxicity to CTCAE 0 or 1or unrecovered from any previous surgery
  -  Known dysphagia or drug malabsorption
  -  Active infections such as acute pneumonia, hepatitis B immune-active periodphase
  -  ocular surface diseases or dry eye syndrome
  -  skin disease with obvious symptoms and signs
  -  significant cardiovascular disease, including II-IV atrioventricular block, and acute myocardial infarction within 6 months, significant angina or Coronary artery bypass graft within 6 months
  -  Female patients who are pregnant or feeding, or childbearing potential patient with pregnant testing positive
  -  Any abnormal of clinical and laboratory so that patients unsuitable to attend the trial sine in the opinion of the investigator
  -  Patients unable to comply with the protocol since significant psychological or psychogenic abnormal

Relevance to patient case: possibly relevant