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ArmA:GFH375

Phase 2

NSCLC (Advanced Non-small Cell Lung Cancer) | Small molecule | Oncology |cbdMD, Inc.|Last Updated: Apr 28, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

Clinical trial landscape

ArmA:GFH375 · 1 trial · 1 indication

Phase 2 1
NCT07554859GFH375 Monotherapy and Combination Therapy as First-Line Treatment for Advanced KRAS G12D-Mutant Non-Small Cell Lung CancerNSCLC (Advanced Non-small Cell Lung Cancer)
NOT YET_RECRUITING90 Analytics
PHASE2NOT YET_RECRUITING
GFH375 Monotherapy and Combination Therapy as First-Line Treatment for Advanced KRAS G12D-Mutant Non-Small Cell Lung Cancer
NSCLC (Advanced Non-small Cell Lung Cancer)Unlock trial analytics

Study Endpoints

Primary Endpoints

the efficacy of GFH375 as monotherapy and in combination therapy
From the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Objective response rate (ORR) assessed by RECIST 1.1 according to researchers

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm A:GFH375EXPERIMENTALArm A :will enroll participants with previously untreated advanced NSCLC harboring KRAS G12D mutations.
Arm B:GFH375 in combination with CetuximabEXPERIMENTALArm B will enroll participants with previously untreated advanced NSCLC harboring KRAS G12D mutations.
Arm C:GFH375 in combination with PemetrexedEXPERIMENTALArm C will enroll participants with previously untreated advanced NSCLC harboring KRAS G12D mutations.

Interventions

NameTypeDescription
ArmA:GFH375DRUGGFH375 once daily (QD) 28 days as a cycle.
Arm B:GFH375DRUGGFH375 once daily (QD) .Cetuximab will be administered via intravenous infusion at a dose of 500 mg/m² every 2 weeks.
Arm C:GFH375DRUGGFH375 once daily (QD) .Pemetrexed disodium will be administered via intravenous infusion at a dose of 500 mg/m² every 3 weeks.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Voluntarily agree to participate in this study and sign the written informed consent form. 2. Male or female, aged 18 to 75 years at the time of signing the informed consent form. 3. Pathologically (histologically or cytologically) confirmed advanced (Stage IV) or locally adv...

Countries:China
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Frequently asked questions about ArmA:GFH375

What is ArmA:GFH375 used for?

ArmA:GFH375 is an investigational small molecule being developed for the treatment of advanced non-small cell lung cancer (NSCLC). It is being studied in patients with KRAS G12D-mutant NSCLC as a first-line treatment, both as a monotherapy and in combination therapy.

Who makes ArmA:GFH375?

ArmA:GFH375 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The company is conducting clinical trials for this investigational drug in advanced non-small cell lung cancer.

What phase is ArmA:GFH375 in?

ArmA:GFH375 is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is designed to evaluate its safety and efficacy in patients with advanced KRAS G12D-mutant non-small cell lung cancer.

What clinical trials is ArmA:GFH375 in?

ArmA:GFH375 is being evaluated in a Phase 2 clinical trial with the identifier NCT07554859. This trial is studying the drug as a first-line treatment for advanced KRAS G12D-mutant non-small cell lung cancer, both as a monotherapy and in combination therapy. The trial is planned to enroll 90 participants in China.

Is ArmA:GFH375 the same as GFH375?

Yes, ArmA:GFH375 is also known as GFH375. The drug is being studied under the name GFH375 in clinical trials, and ArmA:GFH375 is an alternative designation for the same investigational small molecule.

Does ArmA:GFH375 target KRAS G12D?

ArmA:GFH375 is being studied in patients with KRAS G12D-mutant non-small cell lung cancer, indicating that the drug is designed to target tumors with this specific genetic mutation. The clinical trial specifically enrolls patients with KRAS G12D mutations, suggesting the drug's mechanism is related to this molecular target.