Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing different doses of HDM2017 combined with bevacizumab and standard chemotherapy in people with advanced colorectal cancer. They will first find a dose that appears tolerable, then study that dose in a larger group while measuring how the drug behaves in the body and looking for early signs of tumour control.
The idea is that adding HDM2017 to bevacizumab and chemotherapy could control the cancer, but this trial is mainly measuring whether the combinations can be given safely and what the maximum tolerated dose is. Because it is not randomised and has no comparison group, it cannot show that the combination helps people live longer or delays growth more than standard treatment.
Worth knowing: This is an early dose-finding study without a control arm, so its main result will be safety and dosing rather than proof of benefit.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07805551 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | not randomised, open label |
| Taking part | 220 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug HDM2017
- Drug Bevacizumab
- Drug Oxaliplatin
- Drug Fluorouracil
- Drug Capecitabine
- Drug Leucovorin
What it is measuring
Maximum Tolerated Dose (MTD)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
This is a multicenter, open-label, dose-escalation/dose-expansion, Phase Ib/II study to evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor efficacy of HDM2017 combination therapy in participants with advanced CRC. The study is divided into two periods: dose escalation (Phase Ib) and dose expansion (Phase II). Phase Ib of this study is a dose-finding study of different HDM2017 combination therapies. The Phase II study will be conducted at a dose determined to be safe and potentially effective in Phase Ib.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Locally advanced
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: China.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07805551, registered by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.