GH21 Combined With D-1553 in KRAS G12C Mutant Advanced Solid Tumors

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSuzhou Genhouse Bio Co., Ltd.

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

126 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Suzhou Genhouse Bio Co., Ltd.

Lead sponsor

Zhejiang Cancer Hospital

Collaborator