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Can a new drug combo shrink advanced colorectal tumors?

NCT ID NCT07805551

Disease control Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This trial tests whether adding an experimental drug called HDM2017 to standard chemotherapy and bevacizumab can safely shrink tumors in people with advanced colorectal cancer. The study includes adults aged 18 to 75 whose cancer has spread or cannot be removed by surgery. Researchers first find the safest dose, then expand the study to measure how well the combination works.

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 bevacizumab, oxaliplatin, fluorouracil, and capecitabine
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced colorectal cancer, potentially slowing tumor growth and extending survival.
What could go wrong
This is an early-stage trial, so the drug combination may not work as hoped or may cause severe side effects. The results will need confirmation in larger studies before any new treatment becomes available.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Aug 2032

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participants must voluntarily participate in this study and sign the written ICF after being fully informed. 2. Male or female participants aged 18 to 75 years (inclusive). 3. Participants with histologically or cytologically confirmed unresectable locally advanced or metastatic CRC. 4. Able to provide fresh or archived tumor tissue samples during the screening period. 5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1. 6. Life expectancy ≥ 3 months. 7. Participants must have at least one measurable lesion according to RECIST v1.1. 8. Laboratory test results at the screening period must indicate that the participant has adequate organ function. 9. Women of childbearing potential (WOCBP) must agree to use a reasonable method of contraception from the time of signing the ICF until 7 months after the last dose; and must have a negative serum human chorionic gonadotropin (HCG) test within 7 days before the first dose. Male participants must agree to use adequate contraception from the first dose until 7 months after the last dose. 10. Participants must be willing and able to complete regular visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: 1. Prior or current treatment with topoisomerase I (TOP I) inhibitor drugs. 2. Prior or current treatment targeting CDH17. 3. Presence of other malignant tumor, other than the tumor being treated in this study. 4. AEs from prior therapy that have not resolved to Grade 1 or baseline status before prior therapy. 5. Active central nervous system (CNS) metastasis; metastases to meninges or brainstem metastasis; presence of spinal cord compression. 6. Presence of diseases that may affect the efficacy and safety of the IMP. 7. Known or suspected allergic reaction or contraindication to any component of the IMP or its analogues. 8. Pregnant or lactating women, or those who plan to become pregnant during the study.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CRC (colorectal cancer)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Peking University Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

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