New hope for Hard-to-Treat cancers: drug targets KRAS G12D mutation
NCT ID NCT05533463
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This early-stage trial tests a new drug called HRS-4642 in 102 adults with advanced solid tumors that have a specific KRAS G12D mutation. The main goals are to check the drug's safety, find the best dose, and see early signs of tumor shrinkage. Participants must have tried other treatments and have at least one measurable tumor.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS-4642 (a drug that targets the KRAS G12D mutation)
- What this could lead to
- If it works, this could point toward a new 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, so the drug may not prove safe or effective. Only 102 participants are enrolled, and results may not apply to all patients.
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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102 people
The number who actually took part.
- Started
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Sep 2022
- Expected to finish
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Dec 2025
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. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form. 2. Male or female ≥ 18 years old. 3. Histologically confirmed diagnosis of advanced solid tumor harbouring with KRAS G12D mutation 4. ECOG performance status of 0-1. 5. With a life expectancy of ≥3 months. 6. Have at least one measurable lesion. 7. Adequate laboratory parameters during the screening period Exclusion Criteria: 1. Previously received KRAS G12D inhibitors 2. Priot radiotherapy within 28 days for non-thoracic radiation 3. Prior anti-tumor chemotherapy (\< 6 weeks if chemotherapy including nitrosoureas or mitomycin) within 4 weeks before the study drug administration 4. Any unresolved AEs \> Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or inclusion/exclusion criteria level (The investigators determined that safe and controllable toxicity was excluded, such as alopecia and ≤ grade 2 peripheral neuropathy ). 5. Central nervous system (CNS) metastases 6. Major surgical therapy within 28 days prior to the date of signature of informed consent form, or expected major surgery during the study. 7. Known history of hypersensitivity to any components of HRS-4642. 8. Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
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