New hope for Hard-to-Treat cancers: experimental drug targets KRAS mutation
NCT ID NCT06383871
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial is testing a new drug called HRS-7058 in people with advanced solid tumors that have a specific genetic change called KRAS G12C. The study aims to find the safest dose and see if the drug can shrink tumors or slow their growth. About 233 participants will receive the drug in capsule or tablet form.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS-7058 (a drug targeting the KRAS G12C mutation)
- What this could lead to
- If successful, this could point toward a new treatment option for people with advanced cancers that have a specific KRAS G12C mutation.
- What could go wrong
- This is an early Phase 1 trial with a small number of participants, so safety and effectiveness are not yet proven. The drug may not work or could cause significant side effects.
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 233 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Jun 2026
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. The subjects gave informed consent to the study before participating in, and voluntarily signed informed consent; 2. 18 to 75 years old (including both ends), gender is not limited; 3. Subjects with locally advanced or metastatic solid tumour confirmed by histopathology; 4. Having at least one evaluable or measurable lesion according to the solid tumour response Evaluation Criteria (RECIST 1.1); 5. ECOG Performance Status of 0 or 1; 6. The expected survival time is more than 3 months; 7. Be able to ingest drugs and be able to comply with trial and follow-up procedures; 8. Adequate bone marrow and organ function; 9. Fertile women must agree to abstain from sex (abstaining from heterosexual intercourse) or use a highly effective method of contraception for at least one week from the time they sign an informed consent form until the last dose of the study drug. The blood HCG test must be negative within 7 days before the start of the study treatment, and must be non-lactating; 10. For male patients whose partner is a woman of reproductive age, they must agree to abstain from sex for at least one week from signing the informed consent until the last dose of the study drug, or to use a highly effective method of contraception. Exclusion Criteria: 1. Accompanied by untreated or active central nervous system (CNS) tumour metastasis; 2. Had other malignancies within five years prior to first use of the investigational drug; 3. With severe cardiovascular and cerebrovascular disease; 4. Refractory nausea, vomiting, or other gastrointestinal disorders that affect the use of oral medications; 5. The presence of uncontrolled pleural, abdominal or pericardial effusion; 6. Severe infection within 4 weeks prior to initiation of study treatment; 7. History of immune deficiency; 8. The adverse reactions of previous anti-tumour therapy have not recovered to CTCAE ≤ grade 1; 9. Antitumor therapy such as chemotherapy, biotherapy, targeted therapy, immunotherapy, or other unmarketed investigational drug therapy within 4 weeks prior to initial use of the investigational drug; 10. Had undergone major organ surgery within 4 weeks prior to the first use of the study drug; 11. Women who are pregnant, breastfeeding, or who plan to become pregnant within one week of their last use of the study drug during the study period; 12. Known allergies and contraindications to the investigational drug or any of its components; 13. In the investigator's judgment, the subjects had other factors that could have affected the study results or led to the forced termination of the study.
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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
1 site. 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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Tianjin Medical University Cancer Institute and Hospital
RECRUITINGTianjin, Tianjin Municipality, 300060, China
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