Recruiting nowPhase 2
| Registry number | NCT06751329 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | not randomised, open label |
| Taking part | 280 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Xadcera Biopharmaceutical (Suzhou) Co., Ltd. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug DM002
What it is measuring
Dose-limiting Toxicities (DLTs) of DM002
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.
What this trial is trying to do
The researchers are testing DM002 in people with advanced solid tumours, first increasing the dose step by step and then giving the selected dose to a larger group. The record does not state how DM002 is expected to act against the cancer.
The main aim is to find a dose that people can tolerate and to measure how the body handles the drug; the expansion part also looks at how tumours respond. Because the trial has no comparison group, it cannot show whether DM002 is better than standard treatment or helps people live longer.
Worth knowing: This is an early-phase, non-randomised trial whose main outcome is dose-limiting toxicity—side effects that prevent further dose increases—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.
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
The goal of study：
The study has two parts: Part 1 Dose Escalation and Part 2 Dose Expansion.
In Part 1, a few participants will receive the lowest dose of study drug. The study team will make sure it is safe and tolerated before enrolling new participants at a higher dose of study drug. There will be up to six or more dose levels of study drug tested (called cohorts). Which dose you receive will depend on how many participants have taken part in the study before you.
The purpose of Part 1 of the study is to evaluate the safety of the study drug at different dose levels, to understand what your body does to the study drug, and to find the best dose of study drug in people who have advanced solid tumor cancers.
In Part 2, participants will receive the best dose level that was determined in Part 1 of the study.
The purpose of Part 2 of the study is to evaluate the safety of the study drug at the dose level determined in Part 1, to understand what your body does to the study drug, and to see how your cancer responds to the study drug.
Participants will:
Participants will have 17 or more visits to the study centre. This study has a screening phase of up to 28 days , and a treatment phase with cycles of 21 days each. Participants will also have an End of Treatment (EOT) visit 21 days after the final study drug treatment, and a Follow-up visit 30 days after the EOT visit .
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
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
Common Inclusion Criteria (Part 1 and Part 2)
1. Subjects must have the ability to understand and willingness to sign a written informed consent document.
2. Subjects must be ≥18 years of age at the time of signing the informed consent form.
3. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
4. Has a life expectancy of ≥3 months.
5. Participants must meet the following laboratory values within 7 days prior to first dose of study drug:
Note: Transfusion (red blood cell or platelet) or granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 2 weeks prior to laboratory assessments at Screening.
- Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L;
- Platelet count ≥100 × 10⁹/L;
- Hemoglobin ≥9 g/dL;
- Calculated creatinine clearance (CrCL) >60 mL/min (Cockroft-Gault Equation);
- Total bilirubin ≤ 1.5 x ULN;
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × upper limit of normal (ULN), if liver metastases are present, ≤5 × ULN;
- International normalized ratio (INR)<2.0, and prothrombin time and either partial thromboplastin time (PTT) or activated PTT (aPTT) ≤1.5 × ULN, except for participants receiving anti-vitamin K derivative anticoagulant therapy who must have prothrombin time/INR within therapeutic range as deemed appropria…
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 7 sites. Listed in: Australia, United States.
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 NCT06751329, registered by Xadcera Biopharmaceutical (Suzhou) 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.