Recruiting nowPhase 2
What this trial is trying to do
The trial is testing KN035 alone in previously treated colorectal and other solid tumours with deficient mismatch repair (dMMR) or high microsatellite instability (MSI-H). These tumour features can leave many abnormal DNA changes that may make the cancer more visible to immune cells; KN035 is intended to help release this immune response.
The researchers are asking whether KN035 can shrink these cancers after standard treatments, measured by objective response rate—the proportion of participants whose tumours become smaller. This is not a comparison with another treatment, so the trial does not directly show whether it helps people live longer or delays progression more than usual care.
Worth knowing: This is a non-randomised Phase 2 trial with no comparison group, and its main measure is tumour shrinkage rather than survival.
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 | NCT03667170 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 200 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | 3D Medicines (Sichuan) Co., Ltd. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Biological KN035
What it is measuring
Objective Response Rate (ORR)
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
In this study, patients with previously-treated locally-advanced or metastatic mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal carcinoma (CRC) and other solid tumors will be treated with KN035 monotherapy.
For colorectal cancer participants, who are required to have been previously treated with standard therapies , other solid tumor participants, who are required to have been previously treated with at least one line of systemic standard of care therapy.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- dMMR / MSI-H
- 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
- Histologically confirmed locally advanced or metastatic colorectal carcinoma or other malignant solid tumors.
- Confirmed MMR deficient or MSI-H status.
- At least one measureable lesion.
- Eastern Cooperative Oncology Group performance status of 0 or 1 .
- Life expectancy of greater than 12 weeks.
- Adequate hematologic and organ function.
Exclusion Criteria
- Currently participated in a study of an investigational agent and received trial treatment, or used an investigational device within 4 weeks of the first dose of medication in this study. Patients who have had specific anti-tumor treatment within 2 weeks prior to the first dose of study.
- Patients who have not recovered to CTCAE Grade 1 or better from related side effects of any prior antineoplastic therapy.
- Has received prior therapy with an immune check point agonist/inhibitor.
- Patients who have undergone major surgery within 4 weeks of dosing of investigational agent.
- Has a known additional malignancy that is progressing or requires active treatment within the past 5 years.
- Known active central nervous system metastases and/or carcinomatous meningitis.
- Active autoimmune disease that has required systemic treatment.
- Patients who have known history of infection with HIV.
- Patients with evidence of interstitial lung disease.
- Patients who have known history of any major cardiac ab…
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?
- This trial recruits across several cancer types rather than being designed around bowel cancer. Is there evidence it does anything in mine?
The source
Registry record NCT03667170, registered by 3D Medicines (Sichuan) 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.