New hope for hard-to-treat cancers: targeted combo therapy enters trials
NCT ID NCT07259590
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug (GFH375) combined with either cetuximab or chemotherapy in people with advanced solid tumors that have a specific KRAS G12D mutation. The goal is to see if the combination is safe and can shrink tumors. About 126 adults who have not responded to standard treatments will take part.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 126 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Voluntarily participate in the study and sign the informed consent form. 2. 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. 3. Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors, with KRAS G12D mutation. 4. Failed standard systemic treatment, or intolerant to standard treatment, or unsuitable for standard treatment, or no standard treatment available. 5. At least one measurable lesions according to RECIST v1.1 6. 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. 7. Have sufficient organ function. Exclusion Criteria: 1. Symptomatic brain metastasis, leptomeningeal metastasis, spinal cord compression, or primary brain tumor. 2. Presence of known coexisting other cancer driver genes. 3. Previous or active history of clinically significant cardiovascular dysfunction. 4. Presence of active infection. 5. History of central nervous system (CNS) diseases. 6. Presence of clinically significant interstitial lung disease, radiation pneumonitis, or immune-related pneumonitis requiring treatment. 7. Newly diagnosed deep vein thrombosis or pulmonary embolism within 3 months before the first administration of the study treatment. 8. Presence of uncontrolled or symptomatic pleural effusion, ascites, or pericardial effusion. 9. 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. 10. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Cancer Hospital
RECRUITINGBeijing, Beijing Municipality, China
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Sun Yat-sen Memorial Hospital, Sun Yat-sen University
NOT_YET_RECRUITINGGuangzhou, Guangdong, China
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The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITINGZhengzhou, Henan, China
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITINGWuhan, Hubei, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new drug wipe out hidden cancer DNA and stop colorectal cancer from returning?
- Can a pill duo outsmart a Hard-to-Treat pancreatic cancer mutation?
- Can protein patterns in stored tumors point to new treatment targets?
- Can a new drug combo shrink advanced colorectal tumors?
- Can a new pill shrink advanced solid tumors?
- Heat therapy as a palliative aid: does raising body temperature ease advanced cancer symptoms?