GH21 Combined With D-1553 in KRAS G12C Mutant Advanced Solid Tumors (NCT06435455) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
GH21 Combined With D-1553 in KRAS G12C Mutant Advanced Solid Tumors
126 participantsStarted 2024-07-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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
* At least one measurable lesion as defined by RECIST 1.1
Exclusion Criteria:
* 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);
* Pregnant and lactating women;
* The investigator considers that there are any clinical or laboratory abnormalities or other reasons to …
What they're measuring
1
Dose-limiting Toxicities Incidence Count Among Study
Timeframe: 2 years
2
Participants Number of Participants Reporting Adverse Events (AEs) or Serious Adverse Events (SAEs)Objective