Clinical trial NCT06500676: A Study of GFH375 in Patients With Advanced Solid Tumors With KRAS G12D Mutations
Official title: An Open-Label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of GFH375 in Patients With KRAS G12D Mutant Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: KRAS G12D Mutations
Advanced Solid Tumors
Lead sponsor: Genfleet Therapeutics (Shanghai) Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-15
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter, open-label, phase I/II study to explore the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of GFH375 in patients with advanced solid tumors harboring a KRAS G12D mutation.


Eligibility criteria: Inclusion Criteria:

1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
2. Male or female ≥ 18 years old and ≤75 years old.
3. ECOG performance status of 0-1.
4. With a life expectancy of ≥12 weeks.
5. With histologically or cytologically confirmed advanced or metastatic solid tumors harboring KRAS G12D mutation.
6. Have at least one measurable lesion according to RECIST1.1, and the phase Ia allows no measurable lesion.
7. Adequate laboratory parameters during the screening period.

Exclusion Criteria:

1. Active brain metastases.
2. Prior treatment with a KRAS G12D inhibitor.
3. Palliative radiotherapy was completed within 14 days before the first dose.
4. Have poorly controlled or severe cardiovascular disease.
5. Subjects with active hepatitis B or active hepatitis C.
6. Known allergy to the study drug or its components.
7. Pregnant or lactating women.

Primary outcomes:
measure: Phase Ia:The incidence and severity of AEs and SAEs
timeFrame: 24 months
measure: Phase Ia:The incidence of DLT events
timeFrame: 21 days
measure: Phase Ib:The incidence and severity of AEs and SAEs
timeFrame: 24 months
measure: Phase II:Overall response rate (ORR)
timeFrame: 24 months
Secondary outcomes:
measure: Plasma concentrations
timeFrame: up to 21 days
measure: Efficacy endpoints
timeFrame: 24 months
measure: Efficacy endpoints
timeFrame: 24 months
measure: Efficacy endpoints
timeFrame: 24 months
measure: Efficacy endpoints
timeFrame: 24 months
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Nanning
country: China
facility: Guangxi Medical University Cancer Hospital
state: Guangxi
city: Haerbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
state: Liaoning
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Shanhai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
state: Sichuan
city: Tianjing
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjing
city: Hang Zhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Shanghai Chest Hospital
name: Shun Lu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Aiping Zhou, MD
role: PRINCIPAL_INVESTIGATOR
References: