New pill targets Hard-to-Treat KRAS cancers in early human trial
NCT ID NCT06243354
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an experimental drug, HYP-2090PTSA, in people with advanced solid tumors that have a specific genetic change called KRAS mutation. The trial has two parts: first, finding the safest dose, and then testing how well that dose works in certain cancers. About 257 adults with advanced cancer will take part. The goal is to control the disease, not to cure it.
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 257 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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Dec 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 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: * A written informed consent should be signed by a subject or his/her legal representative before any study-related procedures are performed; * 18 Years and older; * Subjects with histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors; * Subjects must have at least one measurable lesion as defined by RECIST v1.1; * Eastern Cooperative Oncology Group(ECOG) performance status 0-1; * Expected survival ≥ 3 months; * Patients are willing to use a highly effective method of birth control during the study, and for at least 180 days after the last dose of study medication. Exclusion Criteria: * Patients who have received major surgical or interventional treatment within 4 weeks prior to the first dose, with the exception of tumor biopsy, puncture, etc. Patients who have received anti-tumor therapy (radiotherapy, immunologic therapy or biological therapy) within 4 weeks, prior to the first dose, or received small molecular targeted therapy, chemotherapy within 2 weeks, or received palliative radiotherapy for bone metastases within 2 weeks, or received nitrosoureas or mitomycin C within 6 weeks; * Patients who have received live vaccines within 4 weeks prior to the first dose; * Patients who have previously participated in clinical trials of other drugs within 4 weeks before the first dose; * Patients with a history of central nervous system disease within 12 months prior to enrollment, such as seizures, cerebral vascular embolism/hemorrhage, paralysis, aphasia, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychiatric disease, or any autoimmune disease with involvement of the central nervous system; * Presence of severe pulmonary diseases such as pulmonary embolism, interstitial lung disease at screening; * Patients who have previously received allogeneic tissue/solid organ transplantation; * Patients with active infection; * Patients who are positive for human immunodeficiency virus (HIV) (HIV1/2 antibody), positive treponema pallidum antibody (positive treponema pallidum antibody is required to undergo a confirmatory test, and those with negative confirmatory test can be enrolled), active chronic hepatitis B (HBsAg positive and HBV DNA \> 500 IU/mL) or active hepatitis C (HCV antibody positive and HCV-RNA \> lower limit of detection by the research center); * Female subjects who are lactating or have a positive blood/urine pregnancy result during the screening period; * Any other condition of the subject (e.g., mental, geographical, or medical condition) that does not allow him or her to comply with the study and follow-up procedures, or other conditions that, in the judgment of the investigator, the subject is not suitable for inclusion in this 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
6 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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Fujian Provincial Cancer Hospital
RECRUITINGFuzhou, Fujian, 350000, China
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Hunan Provincial Cancer Hospital
NOT_YET_RECRUITINGChangsha, Hunan, 410000, China
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Shandong Provincial Cancer Hospital
NOT_YET_RECRUITINGJinan, Shandong, 250000, China
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Shanghai Pulmonary Hospital
RECRUITINGShanghai, Shanghai Municipality, 200000, China
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The first Hospital of China Medical University
NOT_YET_RECRUITINGShenyang, Liaoning, 110000, China
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West China Hospital of Sichuan University
RECRUITINGChengdu, Sichuan, 610000, China
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