Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing whether BMS-986504, a PRMT5 inhibitor that blocks an enzyme involved in cell growth, can be combined with pemetrexed, which interferes with folate-dependent DNA production. The treatment is aimed at metastatic solid tumours whose MTAP gene is deleted, meaning the tumour cells lack a gene involved in recycling materials needed to make DNA.
Because the trial has no comparison group, it is mainly asking whether this combination can be given safely and at what dose; dose-limiting toxicity is the main outcome. Researchers will also examine whether the cancer responds, but this design cannot establish that the combination helps people live longer or delays growth compared with standard treatment.
Worth knowing: This is an early-phase, non-randomised trial, so its main result will concern safety rather than proof of benefit, and eligibility is restricted to tumours with MTAP deletion.
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 | NCT07594626 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 72 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Northwestern University |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Procedure Biospecimen Collection
- Procedure Computed Tomography
- Drug Pemetrexed
- Drug PRMT5 Inhibitor BMS-986504
What it is measuring
Dose limiting toxicity
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 phase Ib/II trial tests the safety and side effects of BMS-986504 in combination with pemetrexed and how well the combination works in treating patients with solid tumors with MTAP deletion and that has spread from where it first started (primary site) to other places in the body (metastatic). The MTAP gene helps cells recycle important parts needed to make deoxyribonucleic acid (DNA), which is needed for cell growth and function. MTAP deletion means that the MTAP gene is missing. BMS-986504, a PRMT5 inhibitor, may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make DNA and may kill tumor cells. Giving BMS-986504 in combination with pemetrexed may be safe, tolerable, and/or effective in treating patients with metastatic solid tumors with MTAP deletion.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Locally advanced
- 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
- COHORT A (INCLUDING SAFETY RUN IN, STAGE I AND STAGE II) AND COHORT B:
- Patients must have pathologically or cytologically confirmed metastatic solid tumor of gastrointestinal origin with MTAP deletion including pancreatic cancer, biliary cancer, esophageal cancer and colon cancer (Cohort A) or other metastatic solid malignancy with MTAP deletion (Cohort B) confirmed by validated next generation sequencing tissue techniques only
- NOTE: Both internal and external validated next generation sequencing (NGS) panels are acceptable
- Progressive disease (PD) after one previous standard of care line of treatment
- NOTE: symptoms from clinical evaluation for PD will be sufficient
- Patients must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1, measured preferably by computed tomography (CT) scan
- Note: Tumor lesions in a previously irradiated area are not considered measurable unless they show unequivocal progression
- NOTE: There is no limit on previous treatment lines
- Patients who have received any neoadjuvant or systemic chemotherapy are eligible
- Note: treatment cannot have included prior pemetrexed unless in the case of non-small cell lung cancer (NSCLC) cancer type. Any prior intravesical therapy, or immunotherapy is allowed.
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: 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 NCT07594626, registered by Northwestern University 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.