About this trial
This s a multi-center, open-label phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of GH21 combined with D-1553 in patients with advanced or metastatic solid tumors harboring KRAS G12C mutation.
Eligibility criteria
Qualifiers
The patient or his legal representative is able to understand and voluntarily sign a written informed consent (before commencing this study and any research procedure);
Age ≥18 years old, male or female;
KRAS G12C mutant advanced solid tumor;
ECOG Performance Status of 0 or 1
Disqualifiers
acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, cerebrovascular accident, or transient ischemic attack within 6 months before first administration; Grade III-IV heart failure based on the New York Heart Association Cardiac Function Scale at screening; During screening, echocardiography (ECHO) showed left ventricular ejection fraction (LVEF) ≤50%;
Patients who have a history of severe allergy, or have a history of allergy to the experimental drug/any excipient/combination drug, or have a history of allergy to multiple drugs;
There is an active infection (≥ grade 2) requiring anti-infective treatment or an unexplained fever exceeding 38 ° C within 28 days before the first dose;
Any toxicity from previous antitumor therapy prior to initial administration has not returned to CTCAE 5.0 rating ≤ Class 1 (unless hair loss, grade 2 peripheral neuropathy, and/or other grade ≤2 adverse events that do not pose a safety risk);
Trial design
Treatments tested in this trial
- GH21
- D-1553
Treatment groups
Locations
Sponsors and collaborators
Suzhou Genhouse Bio Co., Ltd.
Lead sponsor
Zhejiang Cancer Hospital
Collaborator