To hear about similar clinical trials, please enter your email below
Trial Title:
GH21 Combined With D-1553 in KRAS G12C Mutant Advanced Solid Tumors
NCT ID:
NCT06435455
Condition:
Locally Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
GH21
Description:
GH21 Capsules, Oral Drug Specification: 3mg/capsule; 10mg/capsule
Arm group label:
"GH21 + D-1553" Group
Intervention type:
Drug
Intervention name:
D-1553
Description:
D-1553 Film-coated Tablets, Oral Drug Sepcification: 200mg/tablet
Arm group label:
"GH21 + D-1553" Group
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.
Detailed description:
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
July 1, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Suzhou Genhouse Bio Co., Ltd.
Agency class:
Other
Collaborator:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Source:
Suzhou Genhouse Bio Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06435455
