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Phase 2 StudyPhase 2NCT07283705

A Phase II Study Evaluating BMS-986504 in MTAP-deleted Pancreatic Cancer

A Phase 2 study testing BMS-986504, Gemcitabine and Nab-paclitaxel in people with Phase 2 Study and BMS-986504, run by M.D. Anderson Cancer Center 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
Search all trials

Trial summary

To find out if the combination of BMS-986504 plus neoadjuvant/adjuvant chemotherapy and surgery (Cohort 1) or BMS-986504 plus standard of care chemotherapy (Cohorts 2 and 3) can help to control pancreatic cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BMS-986504, Gemcitabine and Nab-paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
9 Apr 2026to 1 Oct 2031
Phase
Phase 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

None listed.

Who cannot join

  • Prior treatment with PRMT5 and MAT2A inhibitors.
  • Exposure to an investigational agent within 30 days or 5 half-lives (whichever is longer) prior to trial enrolment is not permitted.
  • Participants with other primary cancers are excluded, except for adequately treated nonmelanoma skin cancer, prostate cancer post-resection with undetectable PSA, in-situ cervical cancer, ductal carcinoma in situ (DCIS) of the breast, Stage 1 Grade 1 endometrial carcinoma, or solid tumors (including lymphomas without bone marrow involvement) curatively treated with no evidence of disease for ≥2 years prior to study entry.
  • Major surgery within 2 weeks of starting treatment is not permitted. Participants must have recovered from the effects of any major surgery.
  • Significant third-space fluid retention (e.g., ascites or peritoneal effusion) that requires drainage within 1 month prior to randomization.
  • Cardiac abnormalities including:
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  • Left ventricular ejection fraction < 50%
  • History of prolonged QTc, or QT interval corrected for heart rate using Fridericia's formula (QTcF) prolongation > 480 msec, except for right bundle branch block
  • Uncontrolled/symptomatic or significant cardiovascular conditions within 6 months prior to enrollment, including but not limited to any of the following:
  • Cardiac angioplasty or stenting, myocardial infarction, stroke/transient ischemic attack, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, New York Heart Association (NYHA) class III-IV congestive heart failure, pericarditis, myocarditis, atrial fibrillation or other arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or Torsade's de pointes)
  • Ongoing need for a medication with a known risk of Torsade's de Pointes or known as a strong inhibitor or strong inducer of CYP3A4 and/or P-glycoprotein or a proton-pump inhibitor that cannot be switched to alternative treatment prior to study entry. The following drug interaction databases and other literature can be utilized to determine the CYP3A4/Pgp inhibitors and inducers:
  • https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-anddruginteractions- table-substrates-inhibitors-and-inducers.
  • https://druginteractions.medicine.iu.edu/MainTable.aspx. Note: Please consult with the Sponsor Medical Monitor for any uncertainties regarding potential CYP3A4 and P-gp modulators.
  • Active viral hepatitis, including the following:
  • Any positive test result for hepatitis B virus (HBV) indicating presence of virus, e.g., HBV DNA positive would be excluded. Participants with anti-HBs positive in line with prior vaccination or resolved infection are eligible to enroll.
  • Any positive test result for hepatitis C virus (HCV) indicating presence of active viral replication (detectable HCV RNA).
  • Participants with positive HCV antibody and an undetectable HCV RNA are eligible to enroll.
  • Known human immunodeficiency virus (HIV) positive with an AIDS-defining opportunistic infection within the last year, or a current CD4 count < 350 cells/μL. Participants with HIV are eligible if they have received established antiretroviral therapy (ART) for at least 4 weeks prior to randomization and continue on ART as clinically indicated while enrolled on study. Viral serology only to be conducted if locally mandated and, if done, must be performed within 28 days of randomization.
  • Evidence of active infection that requires systemic antibacterial, antiviral, or antifungal therapy ≤ 7 days prior to the first dose of study intervention.
  • 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.
  • 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.
  • Prior organ allograft.
  • History of allergy to study intervention or any of its components.
  • Known central nervous system (CNS) metastases or leptomeningeal disease is exclusionary unless adequately treated and the participant is no longer on steroids or anticonvulsants.
  • Participants unable to swallow oral medication or with gastrointestinal disorders that, per the treating physician's judgement, would likely to interfere with drug absorption, are excluded.
  • Pregnant or breastfeeding women are excluded.
  • History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis, or multiple allergies.
  • Cohort 1 specific criteria:
  • Radiographically detectable metastatic disease and/or locally advanced PDAC.
  • Anticipated need for preoperative radiation therapy (as determined per the treating medical team: medical oncologist and/or surgical oncologist at the time of study enrollment)
  • Cohort 2 specific criteria:
  • Radiographically detectable metastatic disease.
  • Cytotoxic chemotherapy or targeted therapy within 28 days of Cycle 1 Day 1 is not permitted. Palliative radiotherapy must have been completed 14 or more days prior to Cycle 1 Day 1.
  • Participants with more than one prior line of therapy are excluded.
  • Clinically significant persistent toxicities (CTCAE v5.0 Grade ≥2) caused by previous cancer therapy, excluding alopecia and Grade 2 neuropathy, are not allowed.
  • Cohort 3 specific criteria:
  • Cytotoxic chemotherapy or targeted therapy within 28 days of Cycle 1 Day 1 is not permitted. Palliative radiotherapy must have been completed 14 or more days prior to Cycle 1 Day 1.
  • Participants with more than one prior line of therapy are excluded.
  • Clinically significant persistent toxicities (CTCAE v5.0 Grade ≥2) caused by previous cancer therapy, excluding alopecia and Grade 2 neuropathy, are not allowed

Trial locations and contacts

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

Maria P Morelli, MD contact

713-745-1297

giclinicaltrials@mdanderson.org

United States1 site, 1 recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Maria P Morelli, MD, 713-745-1297, giclinicaltrials@mdanderson.org

    Maria P Morelli, MD

    Recruiting

Other trials in United States

About this study

To find out if the combination of BMS-986504 plus neoadjuvant/adjuvant chemotherapy and surgery (Cohort 1) or BMS-986504 plus standard of care chemotherapy (Cohorts 2 and 3) can help to control pancreatic cancer.

Read the detailed description

Primary Objectives

  • Cohort 1: To evaluate the safety and tolerability of BMS-986504 in combination with neoadjuvant/adjuvant chemotherapy and as maintenance therapy in participants with resectable/borderline resectable PDAC. Major pathological response (MPR) and incidence, severity and duration of pre- and post-operative complications (e.g. delay of surgery, inability to get surgery, type and rate of postoperative complications [like pancreatic fistula], rate of resection for borderline participants) will be evaluated.
  • Cohorts 2 and 3: To evaluate the safety, tolerability and efficacy of BMS-986504 in concomitant with SOC chemo and as maintenance therapy. Efficacy will be evaluated as disease control (PFS) at 6 months in participants with locally advanced (Cohort 2) and metastatic (Cohort 3) PDAC.

Secondary Objectives

  • To evaluate 6-month overall response rate (ORR) and disease control rate (DCR) for Cohorts 1,2 and 3
Being tested
BMS-986504, Gemcitabine, Nab-paclitaxel, mFOLFIRINOX

What participants receive

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

Study groups in NCT07283705
Study groupRoleWhat they receive
Cohort 1ExperimentalWill receive a combination of BMS-986504, gemcitabine, and nab-paclitaxel for 4 treatment cycles.
Receives: Drug: BMS-986504; Drug: Gemcitabine; Drug: Nab-paclitaxel
Cohort 2ExperimentalWill receive a combination of BMS-986504, gemcitabine, and nab-paclitaxel for 4-6 months, followed by Maintenance Therapy with BMS-986504 by itself for as long as the disease does not get worse.
Receives: Drug: BMS-986504; Drug: Gemcitabine; Drug: Nab-paclitaxel
Cohort 3ExperimentalWill receive a combination of BMS-986504, and the combination treatment mFOLFIRINOX (oxaliplatin, irinotecan, and 5-fluorouracil) for 4-6 months.
Receives: Drug: BMS-986504; Drug: mFOLFIRINOX

What is being measured

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

  1. Safety and adverse events (AEs)

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Measured: Through study completion; an average of 1 year

Timeline

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

  1. First posted16 Dec 2025
  2. Study start9 Apr 2026
  3. Primary completion1 Oct 2029 (estimated)
  4. Study completion1 Oct 2031 (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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07283705
Sponsor's protocol ID
2025-0804
Other IDs
NCI-2025-09221
Status last verified
Sep 2026
First submitted
11 Dec 2025
Last updated
5 Oct 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 2 study testing BMS-986504, Gemcitabine and Nab-paclitaxel in people with Phase 2 Study and BMS-986504, run by M.D. Anderson Cancer Center 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 0 inclusion and 39 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 5 Oct 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 phase mean?

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 Maria P Morelli, MD (713-745-1297, giclinicaltrials@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and adverse events (AEs) (time frame: Through study completion; an average of 1 year). 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 NCT07283705.

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 5 Oct 2026.

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