BMS-986504 with Pemetrexed for Metastatic Solid Tumors with MTAP Deletion
This study is testing a combination of two drugs, BMS-986504 and pemetrexed, for people with metastatic solid tumors that have an MTAP deletion. Metastatic means the cancer has spread from where it started. An MTAP deletion means a specific gene called MTAP is missing, which can affect how cancer cells grow. BMS-986504 may stop tumor growth by blocking certain enzymes, and pemetrexed works by stopping cancer cells from using folic acid to make DNA. The main goals are to see how safe the combination is and what side effects it causes. Researchers also want to see how well the treatment shrinks tumors. You may be able to join if you have a metastatic solid tumor with an MTAP deletion, including certain gastrointestinal cancers. The current status of this study is unclear.
- Study design
- This is an interventional study with a planned enrollment of 72 participants. It is testing the safety and effectiveness of two drugs given in combination.
- What's involved
- You would receive BMS-986504 by mouth daily for 21 days and pemetrexed intravenously (IV) on day 1 of each 21-day cycle. You would also have blood samples collected and undergo CT scans throughout the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for up to 30 days after your last dose of study treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07594626
BMS-986504 in Combination With Pemetrexed for the Treatment of Metastatic Solid Tumors With MTAP Deletion
Recruiting
PHASE1Ages 18+InterventionalTreatmentNorthwestern UniversityInvestigator-initiated
~72 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:Biospecimen CollectionComputed TomographyPemetrexedPRMT5 Inhibitor BMS-986504
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose limiting toxicity
Measured over Up to 21 days
+4 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesIllinois1
Study leadership
- Devalingam Mahalingam, MD, PhD · PRINCIPAL_INVESTIGATOR · Northwestern University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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. At least 3 weeks (21 days) wash-out period from treatment since prior chemotherapy or radiation therapy or targeted agent is required
Patients must be aged ≥ 18 years
Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Absolute neutrophil count (ANC) ≥ 1,500/mcL (growth factor allowed and can be added at the discretion of the treating oncologist
Growth factors are excluded from being used during the DLT observation period (cycle 1) unless they are being used to treat a grade 4 adverse event which will be counted as a DLT. If growth factors are being used for grade ≤ 3 toxicity, then patients will not be evaluable for DLT assessment
Hemoglobin (Hgb) ≥ 8.5 g/dL (without the need for transfusion within the previous one week)
Platelets (PLT) ≥ 100,000/mL (without the need for platelet transfusion within the previous one week)
Total bilirubin ≤ 1.5 x Institutional upper limit of normal (ULN), except subjects with Gilbert's syndrome or liver metastases, who must have a baseline total bilirubin ≤ 3.0 mg/dL
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) ≤ 3 x institutional ULN or ≤ 5 x ULN if documented liver metastases are present
Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x institutional ULN or ≤ 5 x ULN if documented liver metastases are present
Creatinine clearance ≥ 60 mL/min/1.73 m\^2 using the standard Cockcroft and Gault formula
Patients must have the ability to comply with folic acid, vitamin B12 and steroids as directed by study team and as per standard of care for pemetrexed use
Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
Pemetrexed is known to be teratogenic. Reproductive toxicology studies with MRTX1719 have not been performed. The investigator or designee shall counsel patients of childbearing potential (POCBP) participants and male (as assigned at birth) participants who are sexually active with POCBP on the importance of pregnancy prevention, the implications of an unexpected pregnancy, and the potential of fetal toxicity occurring due to transmission of study intervention present in seminal fluid to a developing fetus, even if the participant has undergone a successful vasectomy or if the partner is pregnant. If needed, participants should be advised to seek advice about egg or sperm donation and cryopreservation of germ cells before treatment
Patients of childbearing potential POCBP
A POCBP is any patient with an egg-producing reproductive tract who meets the following criteria:
Has not undergone a hysterectomy or bilateral oophorectomy
Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months)
POCBP are not permitted to use hormonal contraceptive methods alone as a highly effective method of contraception and must use an additional non-hormonal highly effective method of contraception. POCBP must agree to use a combination of a hormonal and a non-hormonal contraceptive method or a non-hormonal method alone that is highly effective (with a failure rate of \< 1% per year) during the intervention period and for at least 6 months after the last dose of study intervention, or according to approved local product label requirements for pemetrexed, whichever is longer
POCBP participants must also agree not to donate eggs (ova, oocytes) for the purpose of reproduction for the same period
Male (as assigned at birth) participants will be required to always use a latex or other synthetic condom during any sexual activity (eg, vaginal, anal, oral) with POCBP, even if the participant has undergone a successful vasectomy or if the partner is pregnant or breastfeeding. Male (as assigned at birth) participants should continue to use a condom during the intervention period and for at least 6 months after the last dose of study intervention, or according to approved local product label requirements for pemetrexed, whichever is longer
POCBP partners of male (as assigned at birth) participants should be advised to use a highly effective method of contraception during the intervention period and for at least 6 months after the last dose of study intervention for the male participant, or according to approved local product label requirements for pemetrexed, whichever is longer
Male (as assigned at birth) participants with a pregnant or breastfeeding partner must agree to remain abstinent from sexual activity or use a male condom during any sexual activity (eg, vaginal, anal, oral), even if the participant has undergone a successful vasectomy, during the intervention period and for at least 6 months after the last dose of study intervention, or according to approved local product label requirements for pemetrexed, whichever is longer
Male (as assigned at birth) participants must refrain from donating sperm during the intervention period and for at least 6 months after the last dose of study intervention, or according to approved local product label requirements for pemetrexed, whichever is longer
Breastfeeding partners of male (as assigned at birth) participants should be advised to consult their health care provider about using appropriate highly effective contraception during the time the male participant is required to use condoms
POCBP must have a negative pregnancy test prior to registration on study
The ability to interrupt nonsteroidal antiinflammatory drugs (NSAIDS) or aspirin at higher dose (\> 1.3 g daily) 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed
Exclusion
STAGE I AND II, COHORT A (INCLUDING SAFETY RUN IN) AND B:
Patients who received prior pemetrexed containing chemotherapy (apart from NSCLC)
Patients with prior treatment with a PRMT5 or MAT2A inhibitor therapy
Patients with pre-existing clinically significant interstitial lung disease (ILD)
Patients who have had chemotherapy or radiotherapy ≤ 21 days prior to planned treatment start date.
Note: seven days or fewer of palliative radiotherapy for non-CNS disease, is permitted. No wash-out is required
Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia and neuropathy per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
Patients who are receiving any other investigational agents or devices. Patients start of study treatment will be based on their discontinuation and recovery from clinically significant adverse events from their most recent therapy or intervention prior to study enrollment
Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to pemetrexed
Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following:
Ongoing or active infection requiring systemic treatment
Symptomatic congestive heart failure
Unstable angina pectoris
Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification
Note: To be eligible for this trial, patients should be class 2B or better
Patients with presence of third space fluid which cannot be controlled by drainage
Note: For patients who develop or have baseline clinically significant pleural or peritoneal effusions (on the basis of symptoms or clinical examination) before or during initiation of pemetrexed therapy, consideration should be given to draining the effusion prior to dosing. However, if, in the investigator's opinion, the effusion represents progression of disease, the patient should be discontinued from study therapy
Patients who are not able to understand and voluntarily sign a written informed consent and is not willing and able to comply with the protocol requirements including scheduled visits, treatment plan, laboratory tests and other study procedures
Patients who are pregnant or nursing
Patients with history of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications
Patients with Fridericia's formula-corrected QT interval (QTcF) prolongation \> 480 msec, except for right bundle branch block, per the investigator's assessment
Patients with ongoing need for a medication with a known risk of Torsade's de Pointes that cannot be switched to an alternative treatment prior to study entry
Patients with ongoing need for a medication known as a strong inhibitor or strong inducer of cytochrome P450 3A4 (CYP3A4) and/or P-glycoprotein (P-gp) or a proton-pump inhibitor and potassium-competitive acid blockers that cannot be switched to an alternative treatment prior to study entry
NOTE: The following drug interaction databases and other literature can be utilized to determine the CYP3A4/P-gp inhibitors and inducers
Note: Please consult with the manufacturer for any uncertainties regarding potential CYP3A4 and P-gp modulators
Patients with inability to comply with restrictions and prohibited treatments
Patients taking any botanical preparation (e.g., herbal supplements or traditional Chinese medicines) intended to treat the disease under study within 4 weeks prior to treatment. The concurrent use of any botanical preparation is not permitted while on study
Patients with a known history of human immunodeficiency virus (HIV), infected patients on effective anti-retroviral therapy must have a viral load undetectable for 6 months prior to registration. Please note this lab is not a requirement for eligibility, however, if it has been completed previously as part of the patient's health care, it should be documented for eligibility
Patients with a known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Please note this lab is not a requirement for eligibility; however if it has been completed previously as part of the patient's health care, it should be documented for eligibility
Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with a known HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Please note this lab is not a requirement for eligibility; however if it has been completed previously as part of the patient's health care, it should be documented for eligibility
Patients who take live/attenuated vaccine received within 30 days of first treatment. The use of inactivated seasonal influenza vaccines (e.g., Fluzone®) will be permitted on study without restriction
Patient has not received the final dose of any of the following treatments/ procedures with the specified minimum intervals before first dose of study drug:
Surgery with general anesthesia - within 7 days of first dose of study drug
Surgery with local anesthesia - with 3 days of first dose of study drug
What this trial measures
- Dose limiting toxicityUp to 21 days
Will be summarized descriptively by frequency and grade using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
- Incidence of treatment-emergent adverse events (AEs)Up to 30 days after last dose of study treatment
Will be summarized descriptively by frequency and grade using the NCI CTCAE v 5.0. Will be tabulated by system organ class and preferred term.
- Incidence of serious AEsUp to 30 days after last dose of study treatment
Will be summarized descriptively by frequency and grade using the NCI CTCAE v 5.0.
- Incidence of grade 3 or greater adverse eventsUp to 30 days after last dose of study treatment
Will be summarized descriptively by frequency and grade using the NCI CTCAE v 5.0.
- Number of patients who discontinue treatment due to toxicityUp to 30 days after last dose of study treatment