Phase Ia Dose Escalation Subjects with advanced NSCLC and gastrointestinal tumors will be enrolled in dose escalation cohorts based on Bayesian optimal interval (BOIN) design.

Phase Ia Dose Expansion Upon completing the dose exploration part of the study and depending on data obtained, dose expansion may proceed with responsive groups consisting of subjects with KRAS G12C mutant advanced NSCLC. Dose expansion may be done concurrently.

Phase Ib Subjects with KRAS G12C mutant advanced colorectal cancer or other tumors will be enrolled and treated at the monotherapy RP2D to evaluate the efficacy.

Phase 2 Subjects with KRAS G12C mutant advanced NSCLC will be enrolled and treated at the monotherapy RP2D to evaluate the safety and efficacy.

Administered as an oral tablet formulation

GFH925

Bingo Min

Long Yi Wu, doctor

Phase Ia:

To evaluate the safety/tolerability of GFH925 in subjects with KRAS G12C-mutated advanced solid tumors; To estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of GFH925.

Phase Ib:

To evaluate the efficacy of GFH925 in subjects with KRAS G12C mutant advanced colorectal cancer or other tumors.

Phase II:

To evaluate the efficacy of GFH925 in subjects with KRAS G12C mutant advanced non-small cell lung cancer (NSCLC).

A Study of GFH925 in Patients With Advanced Solid Tumors With KRAS G12C Mutations

An Open-label, Multi-center Phase I/II Clinical Study Evaluating the Safety/Tolerability, Pharmacokinetics, and Effectiveness of GFH925 in Patients With Advanced Solid Tumors With KRAS G12C Mutations

Innovent Biologics (Suzhou) Co. Ltd.

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Cetuximab

Antineoplastic Agents, Immunological

GFH925 tablets administered orally daily.

Cetuximab administered intravenously Q2W.

Therapeutics Genfleet

Anna Koumarianou

Stefania Salvagni

Elisa De Carlo

Valentina Guarneri

Federico Cappuzzo

Giuseppe Lo Russo

Vanesa Gregorc

Michele Maio

Michele Milella

Teresa Moran Bueno

Miguel Fernandez de Sanmamed Gutierrez

Maria Gonzalez Cao

Margarita Majem Tarruella

Viteri Santiago

Enriqueta Felip Font

Maria Vanesa Gutierrez Calderon

Reyes Bernabe Caro

Ignacio Gil Bazo

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

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

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

defined as number of patients with treatment emergent AEs

defined as the percent of patients documented a PR/CR

Zhejiang Genfleet Therapeutics Co., Ltd.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of GFH925 in Patients With Advanced Solid Tumors With KRAS G12C Mutations	NCT05005234	KRAS G12C	GFH925	18 Years -	Innovent Biologics (Suzhou) Co. Ltd.
A Study of GFH925 in Combination With Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation	NCT05756153	Advance Non-sma...	GFH925 Cetuximab	18 Years -	Genfleet Therapeutics (Shanghai) Inc.

Spots Global Cancer Trial Database for gfh925

Every month we try and update this database with for gfh925 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gfh925

Every month we try and update this database with for gfh925 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gfh925 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.