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

NCT ID: NCT06435455

Last Updated: 2024-07-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2027-12-31

Brief 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.

Conditions

Locally Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

"GH21 + D-1553" Group

GH21 capsules combined with D-1553 tablets were administrated orally

Group Type: EXPERIMENTAL

GH21

Intervention Type: DRUG

GH21 Capsules, Oral Drug Specification: 3mg/capsule; 10mg/capsule

D-1553

Intervention Type: DRUG

D-1553 Film-coated Tablets, Oral Drug Sepcification: 200mg/tablet

Interventions

GH21

GH21 Capsules, Oral Drug Specification: 3mg/capsule; 10mg/capsule

Intervention Type: DRUG

D-1553

D-1553 Film-coated Tablets, Oral Drug Sepcification: 200mg/tablet

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: collaborator

Suzhou Genhouse Bio Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jieqi Tang, bachelor

Role: CONTACT

tangjieqi@genhousebio.com

+8613311557758

Zhengbo Song, Doctorate

Role: CONTACT

zjccgcp_phase1@126.com

+8613857153345

Other Identifiers

GH21C203

Identifier Type: -

Identifier Source: org_study_id