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

NCT06435455 | Not Yet Recruiting Phase 1

• 1 other identifier: GH21C203
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Locally Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation

Outcome Measures

Primary Outcomes (2)

• Dose-limiting Toxicities Incidence Count Among Study

  Incidence of dose limiting toxicities (DLTs) in the dose escalation phase.

  2 years

• Participants Number of Participants Reporting Adverse Events (AEs) or Serious Adverse Events (SAEs)Objective

  All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs , etc

  2 years

Secondary Outcomes (8)

• response rate (ORR) based on RECIST 1.1 criteria

  2 years

• Duration of response (DOR) based on RECIST 1.1 criteria

  2 years

• Disease Control Rate (DCR) based on RECIST 1.1 criteria

  2 years

• Progression-free survival (PFS) based on RECIST 1.1 criteria

  2 years

• Overall survival (OS)

  2 years

Study Arms (1)

"GH21 + D-1553" Group

EXPERIMENTAL

GH21 capsules combined with D-1553 tablets were administrated orally

Drug: GH21; Drug: D-1553

Interventions

GH21 DRUG

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

"GH21 + D-1553" Group

D-1553 DRUG

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

"GH21 + D-1553" Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Genhouse Bio Co., Ltd.: lead
• Zhejiang Cancer Hospital: collaborator

Central Study Contacts

Jieqi Tang, bachelor

CONTACT

+8613311557758; tangjieqi@genhousebio.com

Zhengbo Song, Doctorate

CONTACT

+8613857153345; zjccgcp_phase1@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 30, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share