Trials
Search / Trial NCT06435455

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

Launched by SUZHOU GENHOUSE BIO CO., LTD. · May 24, 2024

Trial Information

Current as of February 12, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This study includes 2 parts: dose escalation(Phase Ib) and dose expansion (Phase II). The objective of the dose escalation part is to evaluate the safety, tolerability and pharmacokinetics of GH21 in combination with D-1553 in patients with advanced solid tumors harboring KRAS G12C mutation and to determine the RP2D for the combination therapy. In the dose expansion part, preliminary efficacy and safety of the combination therapy at the RP2D will be further explored in patients with specific cancer harboring KRAS G12C mutation.

Gender

ALL

Eligibility criteria

  • 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 be unsuitable for participating in this clinical study.

About Suzhou Genhouse Bio Co., Ltd.

Suzhou Genhouse Bio Co., Ltd. is a pioneering biotechnology company committed to advancing therapeutic solutions through innovative research and development. Based in Suzhou, China, the company specializes in the discovery and commercialization of biopharmaceuticals, focusing on novel drug candidates that target unmet medical needs. With a dedicated team of scientists and industry experts, Genhouse Bio leverages cutting-edge technologies to drive clinical trials and accelerate the development of safe and effective treatments. Their mission is to enhance patient outcomes and contribute to global health advancements through rigorous scientific inquiry and collaboration.

Locations

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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