Phase 2 Study of WGI-0301 Plus Lenvatinib in Patients With Advanced HCC
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang Haichang Biotech Co., Ltd.
About this trial
This is a Phase II study being done at several hospitals without using a placebo. It will look at how safe and tolerable the drug WGI-0301 is when given together with Lenvatinib, how the body processes and responds to WGI-0301, and whether this combination shows early signs of working in people with advanced liver cancer.
Eligibility criteria
Qualifiers
1. ≥18 years of age on the day of signing informed consent, male or female. 2. Voluntarily agree to provide signed informed consent and are willing and able to comply with all aspects of the protocol.
Child-Pugh Liver Function Class A or Class B (score ≤ 7) (see Appendix 6 in Section 14.6)
AST and ALT ≤ 3.0 × ULN, and total bilirubin ≤ 2 × ULN
Serum albumin ≥ 2.8 g/ dL
Disqualifiers
1. Pregnant or breastfeeding patients or expecting to conceive or father children within the projected duration of the study.
Uncontrolled chronic hypertension, defined as systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥ 90 mmHg based on the average of ≥ 2 measurements; or a history of hypertensive crisis or hypertensive encephalopathy.
Clinically significant hypotension as assessed by the investigator (e.g., systolic blood pressure < 90 mmHg or mean arterial pressure < 65 mmHg on two consecutive measurements at the Screening Visit).
NYHA class III or IV Congestive heart failure, myocardial infarction or stroke, unstable angina pectoris, pericardial effusion (excluding trace pericardial effusion identified by echocardiography) or left ventricular ejection fraction < 45% within 6 months prior to the first dose.
Trial design
Treatments tested in this trial
- WGI-0301
- WGI-0301
- Lenvatinb
Treatment groups
80 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov