New drug cocktail hopes to tackle advanced colon cancer
NCT ID NCT07621159
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new drug called HDM2017 combined with standard treatment (fruquintinib) in 120 people with advanced colorectal cancer that has spread. The goal is to find the safest dose and see if the combination can shrink tumors. Participants must have tried other treatments and have a life expectancy of at least 3 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HDM2017 combined with fruquintinib
- What this could lead to
- If successful, this could lead to a new treatment option for advanced colorectal cancer that may shrink tumors or slow disease progression.
- What could go wrong
- This is an early-phase trial (Phase 1/2) with only 120 participants, so results may not confirm effectiveness. Side effects from the drug combination are unknown and could be severe.
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 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 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 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. Be able and willing to provide written informed consent. 2. Male or female participants with age ≥ 18 years. 3. Participants with histologically or cytologically confirmed unresectable locally advanced or metastatic colorectal adenocarcinoma. 4. Be able to provide archived tumor tissue during the screening period. 5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. 6. Life expectancy ≥3 months. 7. According to RECIST v1.1, participants must have at least one measurable lesion. 8. Has adequate organ function. 9. All subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 7 months after the last dose of study treatment. 10. Be willing and able to complete regular visits, treatment plans, laboratory tests, and other trial procedures. Exclusion Criteria: 1. Participants who have previously received treatment with an anti-VEGFR tyrosine kinase inhibitor (TKI). 2. Participants who have previously received ADC therapy containing Top I inhibitors, or other drug therapy targeting the CDH17 target. 3. Participants with other malignant tumors within the past 5 years, other than the tumor being treated in this study, with the exception of locally cured tumors (such as basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix or breast). 4. Related AEs from prior therapy (except for alopecia and ≤Grade 2 sensory neuropathy) have not recovered to ≤Grade 1 or baseline level. 5. Known weight loss of \>10% within 2 months before the first dose of study drug or other indicators showing severe malnutrition. 6. History of severe esophagogastric varicose vein, severe ulcer, gastrointestinal perforation, abdominal fistula, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months before the first dose. 7. Participants with current imaging or clinical evidence of significant gastrointestinal obstruction. 8. Participants with clinically significant bleeding symptoms within 1 month before the first IMP dose. 9. Participants with known active CNS metastasis. 10. Participants with cardiovascular/cerebrovascular disorder, symptoms, or manifestations. 11. Participants with active syphilis, history of human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) or active hepatitis C virus (HCV), except for asymptomatic chronic hepatitis B or C virus carriers.
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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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Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142, China
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