A Study of GFH375 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors Harboring KRAS G12D Mutation
Recruiting · NCT07259590 · Interventional (participants receive a specific treatment) · Lead sponsor: Genfleet Therapeutics (Shanghai) Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This is a Phase Ib/II clinical study aimed at exploring the safety and efficacy of Regimen A (GFH375 in combination with Cetuximab) and Regimen B (GFH375 in combination with AG) in participants with solid tumors.Phase Ib: To evaluate the safety/tolerability and pharmacokinetic (PK) characteristics of GFH375 in combination with cetuximab or AG in participants with solid tumors, and to explore the efficacy of the combination therapy. Phase II: To evaluate the efficacy, safety/tolerability and PK characteristics of the combination therapy, and to explore the correlation between bio-marker and clinical efficacy.
Who can take part
Inclusion criteria
- Voluntarily participate in the study and sign the informed consent form.
- Participants receiving Regimen A must be ≥ 18 years old when signing the informed consent form, and participants receiving Arm B must be 18 - 75 years old.
- Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors, with KRAS G12D mutation.
- Failed standard systemic treatment, or intolerant to standard treatment, or unsuitable for standard treatment, or no standard treatment available.
- At least one measurable lesions according to RECIST v1.1
- Participants receiving Regimen A must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 - 2; participants receiving Regimen B must have an ECOG PS score of 0 - 1.
- Have sufficient organ function.
Exclusion criteria
- Symptomatic brain metastasis, leptomeningeal metastasis, spinal cord compression, or primary brain tumor.
- Presence of known coexisting other cancer driver genes.
- Previous or active history of clinically significant cardiovascular dysfunction.
- Presence of active infection.
- History of central nervous system (CNS) diseases.
- Presence of clinically significant interstitial lung disease, radiation pneumonitis, or immune-related pneumonitis requiring treatment.
- Newly diagnosed deep vein thrombosis or pulmonary embolism within 3 months before the first administration of the study treatment.
- Presence of uncontrolled or symptomatic pleural effusion, ascites, or pericardial effusion.
- Having received major surgery within 28 days before the start of the study treatment; having experienced major trauma within 14 days before the start of the study treatment; or planning to undergo major surgery during the study period.
- Having received radiotherapy within 4 weeks before the start of the study treatment, or having received palliative radiotherapy for bone metastatic lesions within 2 weeks before the start of the study treatment.
Where it is running
4 locations listed.
- Beijing Cancer Hospital - Beijing, Beijing Municipality, China
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University - Guangzhou, Guangdong, China
- The First Affiliated Hospital of Zhengzhou University - Zhengzhou, Henan, China
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology - Wuhan, Hubei, China