New hope for Hard-to-Treat cancers: targeted drug enters human testing
NCT ID NCT07134998
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests a new drug called HRS-6093 in people with advanced solid tumors that have a specific mutation called KRAS G12D. The study aims to find a safe dose and see how the drug affects the body. About 153 participants will be enrolled across multiple centers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS-6093
- What this could lead to
- If successful, this could lead to a new targeted treatment option for people with advanced cancers that have a specific KRAS G12D mutation.
- What could go wrong
- This is a very early Phase 1 trial with only 153 participants, so safety and effectiveness are not yet proven. The drug may cause side effects or fail to shrink tumors.
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
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 153 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Dec 2028
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 to 75 years
- 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. Have fully understood this study and are willing to sign the ICF, with good compliance and cooperation in follow-up; 2. Aged between 18-75 years, with no gender requirement; 3. Participants with histologically/cytologically confirmed advanced solid tumors who have been previously tested or are confirmed by the central laboratory to harbor KRAS G12D mutations; Have failed standard treatment, are intolerant to standard treatment, or have not received standard treatment. 4. ECOG performance status (PS) score of 0 or 1; 5. Life expectancy \> 3 months; 6. At least one measurable lesion per RECIST v1.1; A tumor tissue sample must be provided. 7. Adequate organ function Exclusion Criteria: 1. Toxicity (e.g., gastrointestinal reaction and skin toxicity) from prior anti-tumor treatment has not recovered to Grade ≤ 1 or a level specified in the inclusion/exclusion criteria; 2. Presence of central nervous system (CNS) metastases; 3. Participants with gastrointestinal diseases that affect drug administration/absorption 4. Participants who have undergone major surgery other than diagnosis or biopsy within 28 days before the first dose, or are expected to undergo major surgery during the study period; 5. Presence of serious pulmonary diseases 6. Active tuberculosis or a history of active tuberculosis infection within 48 weeks prior to screening, regardless of whether they have been treated; 7. Active or persistent gastrointestinal bleeding within 6 months prior to screening; 8. History of allogeneic bone marrow or solid organ transplantation; 9. History of deep vein thrombosis or pulmonary embolism within 6 months prior to screening; 10. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring clinical intervention; 11. Positive human immunodeficiency virus (HIV) (HIV1/2 antibodies), active chronic hepatitis B, or active hepatitis C (positive HCV antibody and positive HCV RNA); 12. Known history of hypersensitivity to any component of the drug product to be used in the study;
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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
2 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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Shanghai Jiao Tong University School of Medicine
RECRUITINGShanghai, Shanghai Municipality, 200025, China
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West China Hospital of Sichuan University
RECRUITINGChengdu, Sichuan, 610041, China
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