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A Study of GFH925 in Combination With Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation

Primary Purpose

Advance Non-small Cell Lung Cancer

Status
Recruiting
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
GFH925
Cetuximab
Sponsored by
Zhejiang Genfleet Therapeutics Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advance Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient has provided informed consent form (ICF). Males or females aged ≥ 18 years. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1. Life expectancy > 3 months judged by the investigator. Have histologically or cytologically confirmed advanced KRAS G12C-mutated NSCLC. Have at least one measurable lesion per RECIST 1.1. Have sufficient organ functions. With toxicities left from prior anti-tumor therapy resolved to baseline or CTCAE Grade 1 (neurotoxicity or alopecia ≤ Grade 2). Women of childbearing potential (WOCBP) and male patients with WOCBP partners must agree to use effective contraception method during the study specified period. Exclusion Criteria: With clinically significant cardiovascular diseases. With active central nervous system (CNS) metastases and/or carcinomatous meningitis. With clinically significant gastrointestinal diseases. With active infections. With uncontrollable or symptomatic pleural effusion, ascites, or pericardial effusion. With uncontrolled systemic diseases, such as hypertension or diabetes. Prior treatment with an inhibitor specific to KRAS G12C. Major surgery within 4 weeks prior to initiation of study treatment. With known allergies to the study drugs or components. Pregnant or lactating females, or female patients intend to become pregnant during participation.

Sites / Locations

  • Clinica Mi Tres TorresRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GFH925+Cetuximab

Arm Description

Outcomes

Primary Outcome Measures

Phase Ib: adverse events
defined as number of patients with treatment emergent AEs
Phase II: objective response rate
defined as the percent of patients documented a PR/CR

Secondary Outcome Measures

Full Information

First Posted
February 12, 2023
Last Updated
May 16, 2023
Sponsor
Zhejiang Genfleet Therapeutics Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05756153
Brief Title
A Study of GFH925 in Combination With Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation
Official Title
A Phase Ib/II, Multi-Center, Open-Label Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFH925 in Combination With Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Genfleet Therapeutics Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a Phase Ib/II study. The objectives are to evaluate the safety/tolerability and efficacy of GFH925 in combination with Cetuximab in advanced KRAS G12C mutant NSCLC, to characterize pharmacokinetics (PK) of GFH925 in combination with Cetuximab in advanced KRAS G12C mutant NSCLC

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advance Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GFH925+Cetuximab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
GFH925
Intervention Description
GFH925 tablets administered orally daily.
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
Cetuximab administered intravenously Q2W.
Primary Outcome Measure Information:
Title
Phase Ib: adverse events
Description
defined as number of patients with treatment emergent AEs
Time Frame
28 days
Title
Phase II: objective response rate
Description
defined as the percent of patients documented a PR/CR
Time Frame
up to 1 year after last patient in

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient has provided informed consent form (ICF). Males or females aged ≥ 18 years. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1. Life expectancy > 3 months judged by the investigator. Have histologically or cytologically confirmed advanced KRAS G12C-mutated NSCLC. Have at least one measurable lesion per RECIST 1.1. Have sufficient organ functions. With toxicities left from prior anti-tumor therapy resolved to baseline or CTCAE Grade 1 (neurotoxicity or alopecia ≤ Grade 2). Women of childbearing potential (WOCBP) and male patients with WOCBP partners must agree to use effective contraception method during the study specified period. Exclusion Criteria: With clinically significant cardiovascular diseases. With active central nervous system (CNS) metastases and/or carcinomatous meningitis. With clinically significant gastrointestinal diseases. With active infections. With uncontrollable or symptomatic pleural effusion, ascites, or pericardial effusion. With uncontrolled systemic diseases, such as hypertension or diabetes. Prior treatment with an inhibitor specific to KRAS G12C. Major surgery within 4 weeks prior to initiation of study treatment. With known allergies to the study drugs or components. Pregnant or lactating females, or female patients intend to become pregnant during participation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Therapeutics Genfleet
Phone
+86 21 6882 1388
Email
GFH925X0201@genfleet.com
Facility Information:
Facility Name
Clinica Mi Tres Torres
City
Barcelona
ZIP/Postal Code
8017
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Viteri Santiago
Phone
0034 932287445
Email
sviteri@uomi.es

12. IPD Sharing Statement

Learn more about this trial

A Study of GFH925 in Combination With Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation

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