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Metastatic Biliary Tract CarcinomaPhase 1/2NCT07594626

BMS-986504 in Combination With Pemetrexed for the Treatment of Metastatic Solid Tumors With MTAP Deletion

A Phase 1/2 study testing Biospecimen Collection, Computed Tomography and Pemetrexed in people with Metastatic Biliary Tract Carcinoma and Metastatic Colon Carcinoma, run by Northwestern University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Computed Tomography and Pemetrexed
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteUnited States
Study dates
21 Aug 2026to 9 Dec 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 36Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Study Coordinator contact

3126951301

cancer@northwestern.edu

United States1 site, 1 recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Devalingam Mahalingam, MD, PhD, 210-413-1723, mahalingam@northwestern.edu

    Devalingam Mahalingam, MD, PhD

    Recruiting

Other trials in United States

About this study

Official title: A Phase Ib/II Basket Study of BMS-986504 in Combination With Pemetrexed for Metastatic Solid Tumors With MTAP Deletion

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess the safety, tolerability and dose limiting toxicity (DLT) of PRMT5 inhibitor BMS-986504 (BMS-986504) in patients with metastatic solid tumors with homozygous deletion of the MTAP gene treated with BMS-986504 in combination with pemetrexed.

SECONDARY OBJECTIVES:

  1. To assess the overall response rate (ORR) in patients with metastatic solid tumors homozygous deletion of the MTAP gene treated with BMS-986504 in combination with pemetrexed.

II. To assess the duration of response (DOR) among patients achieving an objective response, defined as the time from first documented response to disease progression or death.

EXPLORATORY OBJECTIVES:

  1. To descriptively summarize overall survival (OS) in the treated population. II. To descriptively summarize progression-free survival (PFS) in the treated population.

III. To descriptively assess the pharmacokinetics of BMS-986504 in combination with pemetrexed.

OUTLINE:

Patients receive BMS-986504 orally (PO) once daily (QD) on days 1-21 and pemetrexed intravenously (IV) over 10 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and computed tomography (CT) throughout the study.

After completion of study treatment, patients are followed up at 30 days and then every 3 months for up to 12 months.

Being tested
Biospecimen Collection, Computed Tomography, Pemetrexed, PRMT5 Inhibitor BMS-986504
Medical subject headings
Colonic Neoplasms, Esophageal Neoplasms, Gastrointestinal Neoplasms, Neoplasm Metastasis, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • PemetrexedDrug

    Also called MTA, Multitargeted Antifolate, Pemfexy

    Given IV

  • PRMT5 Inhibitor BMS-986504Drug

    Also called BMS 986504, BMS-986504, BMS986504, MRTX 1719

    Given PO

Study groups in NCT07594626
Study groupRoleWhat they receive
Treatment (BMS-986504, pemetrexed)ExperimentalPatients receive BMS-986504 PO QD on days 1-21 and pemetrexed IV over 10 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and CT throughout the study.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Pemetrexed; Drug: PRMT5 Inhibitor BMS-986504

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limiting toxicity

    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.

    Measured: Up to 21 days

  2. Incidence of treatment-emergent adverse events (AEs)

    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.

    Measured: Up to 30 days after last dose of study treatment

  3. Incidence of serious AEs

    Will be summarized descriptively by frequency and grade using the NCI CTCAE v 5.0.

    Measured: Up to 30 days after last dose of study treatment

  4. Incidence of grade 3 or greater adverse events

    Will be summarized descriptively by frequency and grade using the NCI CTCAE v 5.0.

    Measured: Up to 30 days after last dose of study treatment

  5. Number of patients who discontinue treatment due to toxicity

    Measured: Up to 30 days after last dose of study treatment

Secondary outcomes (2)

  1. Objective response rate

    Will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. Will be defined as the overall percentage of patients with complete response (CR) plus partial response (PR). Point estimates and corresponding two-sided 95% exact (Clopper-Pearson) confidence intervals will be reported. Will be compared against the null hypothesis rate of 15% using a one-sided binomial test consistent with the Simon's two-stage design framework.

    Measured: From baseline until disease progression, initiation of subsequent anti-cancer therapy, or completes study participation, whichever occurs first, assessed up to 12 months

  2. Duration of response (DOR)

    Disease progression will be defined as experiencing progressive disease per RECIST v 1.1 or death due to disease. Will be analyzed using the Kaplan-Meier method, with censoring at the date of the last tumor assessment prior to progression or death. Median DOR and corresponding 95% confidence intervals will be reported.

    Measured: From the day when CR or PR is first observed until the earlier of the day of first documented disease progression or death from any cause, assessed up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2026
  2. Study start21 Aug 2026
  3. Primary completion9 Dec 2030 (estimated)
  4. Study completion9 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07594626
Sponsor's protocol ID
NU 25MH07
Other IDs
NCI-2026-03369, STU00225627, NU 25MH07, P30CA060553
Status last verified
Aug 2026
First submitted
13 May 2026
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Biospecimen Collection, Computed Tomography and Pemetrexed in people with Metastatic Biliary Tract Carcinoma and Metastatic Colon Carcinoma, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 36 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Coordinator (3126951301, cancer@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicity (time frame: Up to 21 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07594626.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.

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