Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing whether INV-8989 can be given safely and tolerated by people whose advanced solid tumours carry the KRAS G12D mutation, while also measuring how the drug behaves in the body and whether it shows early signs of shrinking or controlling cancer.
The idea is that a treatment directed at this specific cancer-associated mutation could provide an option for these patients, but the trial is mainly measuring treatment-related side effects and only preliminary antitumour activity, not whether people live longer or go longer before the cancer grows.
Worth knowing: This is a non-randomised early-phase study with no comparison group, and its main reported outcome is safety rather than treatment 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 | NCT07610798 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | not randomised, open label |
| Taking part | 178 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Shenzhen Ionova Life Sciences Co., Ltd. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug INV-8989
What it is measuring
Phase 1: Number of participants with treatment-emergent adverse events (TEAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
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 Phase 1 and Phase 2 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of INV-8989 in patients with advanced solid tumors harboring KRAS G12D mutations.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Locally advanced
- Rectal
- Colon
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. Written informed consent obtained.
2. Adult patients aged ≥ 18 years.
3. Patients with histologically or cytologically confirmed locally advanced, unresectable, or metastatic solid tumors harboring the KRAS G12D mutations.
4. Agree to provide available archived FFPE tumor tissue specimens or voluntarily accept pre-treatment tumor biopsy.
5. Have RECIST 1.1-defined measurable lesions.
6. Has a life expectancy of > 3 months.
7. ECOG performance status 0-1.
8. Adequate marrow, liver and kidney function.
9. Meet the study's specified contraceptive requirements.
10. Meet protocol-specified washout period requirements.
Exclusion Criteria
1. Have protocol-defined toxicities within 28 days before the start of study treatment.
2. Have a second primary malignancy.
3. Patients with known hypersensitivity to the study drug or any of its components.
4. Prior history of receiving targeted therapy with specific KRAS G12D inhibitors/degraders or pan-RAS inhibitors/degraders for KRAS G12D mutation.
5. Has undergone major surgery within 28 days prior to the first dose of study drug.
6. Patients with symptomatic brain or leptomeningeal metastases.
7. Patients with other severe and persistent underlying medical conditions as assessed by the Investigator.
8. Have protocol-defined clinically significant cardiovascular diseases.
9. Prolonged QTcF interval.
10.
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 NCT07610798, registered by Shenzhen Ionova Life Sciences 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.