Advanced CancerPhase 1NCT07382544
Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss
A Phase 1 study testing MRTX1719 and Olaparib in people with Advanced Cancer and Solid Tumor, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn about the safety and effects of BMS-986504 in combination with olaparib in patients with advanced solid tumors with MTAP loss. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Solid Tumor
- What is being tested?
- MRTX1719 and Olaparib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2026to 31 Jan 2032
- Phase
- Phase 1
- 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
- Age ≥18 years.
- All patients must have a histologically confirmed advanced or metastatic solid tumor that has been refractory to standard therapy or are not eligible for standard therapy and have no alternative curative-intent treatment options at the time of patient enrollment. For the dose escalation, any solid tumor is eligible, but enrollment will be enriched for CCA and pancreatic cancer. For the pharmacodynamic expansion, patients must have histologically confirmed advanced or metastatic CCA or pancreatic cancer.
- Homozygous deletion of MTAP as detected by Clinical Laboratory Improvement Amendmentscertified next-generation sequencing test or absence of MTAP protein as detected by CLIAcertified immunohistochemistry test.
- Patients in Part A must have archived tumor tissue available for retrospective analysis or agree to pre-treatment biopsy.
- Ability to understand and the willingness to sign a written informed consent document.
- Ability to comply with the study protocol, in the investigator's judgment.
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix 1).
- Life expectancy ≥3 months.
- Patients in the pharmacodynamic expansion must have measurable and biopsiable disease per the RECIST v1.1 (Appendix 2). Patients in the dose escalation can have evaluable or measurable disease.
- Patients must have adequate washout from prior therapy at the time of study treatment initiation: 3 weeks from any treatment specifically for systemic tumor control: 5 half-lives from small molecule targeted agents and ≥ 2 weeks from radiotherapy (except for patients with brain metastasis treatment with Gamma Knife; in these cases, > 1 week is required). Palliative radiotherapy is permitted for a preexisting lesion, provided it does not interfere with the assessment of tumor target lesions (e.g., the lesion to be irradiated must not be a site of measurable disease).
- Patients must have recovered from toxicities of prior anticancer therapy (Grade ≤ 1 toxicity) except for alopecia and peripheral neuropathy.
- Adequate organ and marrow function as defined below within 28 days prior to study treatment initiation:
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1500/mm3
- Platelets ≥ 100,000/mm3
- Adequate renal function: Estimated glomerular filtration rate ≥ 50 mL/min/1.73 m2 by the Chronic Disease Epidemiology Collaboration equation; estimated creatinine clearance ≥50 mL/min (calculated using institutional standard method).
- Adequate hepatic function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Patients with Gilbert's syndrome with total bilirubin ≤ 2.0 × ULN and direct bilirubin within normal limits are permitted; Aspartate aminotransferase/ALT ≤ 3 × institutional ULN or ≤ 5 × ULN for patients with liver metastases.
- For patients not receiving therapeutic anticoagulation: international normalized ratio or activated partial thromboplastin time ≤1.5 × ULN. For patients receiving therapeutic anticoagulation: stable anticoagulant regimen.
- Patients must be able to take PO medications.
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result within 72 hours prior to study treatment initiation.
- WOCBP must agree to use adequate contraception as described below from the screening visit through at least 6 months after the last dose of study treatment. (Refer to Pregnancy Assessment Policy MD Anderson Cancer Center [MDACC] Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
- Postmenopausal (no menses in ≥ 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (follicle-stimulating hormone and estradiol in menopausal range and have received whole pelvic radiation therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure.
- WOCBP 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: copper intrauterine device) 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 individual chemotherapy agents, whichever is longer.
- WOCBP 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.
- WOCBP must also agree not to donate eggs (ova, oocytes) for the purpose of reproduction for the same period. Participants should be advised to seek advice about egg donation and cryopreservation of germ cells before treatment.
Who cannot join
- Part B only: Prior treatment with a PRMT5 or methionine adenosyltransferase 2A inhibitor.
- Patients who have a known additional malignancy that is progressing or requires active treatment at time of study treatment initiation. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, and in situ cervical cancer.
- Patients with meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, or symptomatic or unstable brain metastases. Note: Patients with stable brain metastases (defined as asymptomatic or no requirement for high-dose or increasing dose of systemic corticosteroids and without imminent need of radiation therapy) are eligible (including those with untreated brain metastases). If applicable, patients must have completed brain radiation therapy and recovered adequately from any associated toxicity and/or complications prior to eligibility assessment.
- Concomitant use of strong cytochrome P450 (CYP)3A inhibitors or inducers are prohibited within 14 days or 5 half-lives, whichever is longer, prior to study treatment initiation and during the study treatment period. For a comprehensive list of CYP3A inhibitors/inducers, refer to: https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactionstable-substrates-inhibitors-and-inducers.
- Any clinically significant comorbidities such as uncontrolled pulmonary disease, known impaired cardiac function or clinically significant cardiac disease (including but not limited to known left ventricular ejection fraction < 50%, congenital long QT syndrome, corrected QT interval using Fridericia's formula ≥ 480 msec on screening electrocardiogram [ECG], unstable angina pectoris ≤ 3 months prior to study treatment initiation, and acute myocardial infarction ≤ 3 months prior to study treatment initiation), or any other condition that could compromise the patient's participation in the study.
- Treatment with a live, attenuated vaccine within 4 weeks prior to study treatment initiation.
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- Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, Bacille Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Non-live COVID vaccines will be allowed on study, but it is recommended to avoid their use during the first treatment cycle (from 3 days prior to Cycle 1 Day 1 through Cycle 2 Day 3).
- Concomitant use of medications known to be sensitive substrates of breast cancer resistance protein (including, but not limited to, rosuvastatin and sulfasalazine) or P-glycoprotein (P-gp; including, but not limited to, dabigatran etexilate, digoxin, fexofenadine).
- Patients who are pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 7 months after the last dose of study treatment.
- Any known psychiatric, substance abuse, or other disorder that would interfere with cooperation with the requirements of the study, in the opinion of the investigator.
- Patients who are receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drugs.
- Patients who have an active infection requiring intravenous (IV) antibiotics.
- Patients with any gastrointestinal disorder that would significantly alter the absorption of the study drugs (e.g., active ulcerative diseases, uncontrolled nausea, uncontrolled vomiting, uncontrolled diarrhea, malabsorption syndrome).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Jordi Rodon Ahnert, MD, PHD, 713-792-5603, jrodon@mdanderson.org
Jordi Rodon Ahnert, MD, PHD
About this study
Official title: Phase 1b Trial of Combined PRMT5 Inhibition With BMS-986504 and PARP Inhibition With Olaparib in Patients With Advanced Cancer With MTAP Loss
The goal of this clinical research study is to learn about the safety and effects of BMS-986504 in combination with olaparib in patients with advanced solid tumors with MTAP loss.
Read the detailed description
Primary Objective:
- To determine the safety and tolerability of BMS-986504 in combination with olaparib in patients with advanced solid tumors with MTAP loss.
Secondary Objectives:
- To characterize the PK profile of BMS-986504 in combination with olaparib in patients with advanced solid tumors with MTAP loss.
- To determine the preliminary antitumor activity of BMS-986504 in combination with olaparib with advanced solid tumors with MTAP loss.
- To evaluate the pharmacodynamic activity of BMS-986504 in combination with olaparib in advanced solid tumors with MTAP loss.
- To evaluate predictors of response and resistance to BMS-986504 in combination with olaparib in patients with advanced solid tumors with MTAP loss.
- Conditions
- Advanced Cancer, Solid Tumor
- Being tested
- MRTX1719, Olaparib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRTX1719Drug
Given by mouth
OlaparibDrug
Also called Lynparza
Given by mouth
| Study group | Role | What they receive |
|---|---|---|
| Part A Dose Escalation: Treatment with BMS-986504 + Olaparib | Experimental | Study treatment will be administered on an outpatient basis Receives: Drug: MRTX1719; Drug: Olaparib |
| Part B Pharmacodynamic Expansion Cohort 1: Treatment with BMS-986504 at C1D1 + Olaparib at C1D15 | Experimental | Study treatment will be administered on an outpatient basis Receives: Drug: MRTX1719; Drug: Olaparib |
| Part B Pharmacodynamic Expansion Cohort 2: Treatment with Olaparib at C1D1 + BMS-986504 at C1D15 | Experimental | Study treatment will be administered on an outpatient basis Receives: Drug: MRTX1719; Drug: Olaparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted3 Feb 2026
- Study start12 Feb 2026
- Primary completion31 Jan 2030 (estimated)
- Study completion31 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jordi Rodon Ahnert, MD, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382544
- Sponsor's protocol ID
- 2025-1200
- Other IDs
- NCI-2025-09342
- Status last verified
- Aug 2026
- First submitted
- 29 Dec 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Trial of Combined PRMT5 Inhibition With BMS-986504 and PARP Inhibition With Olaparib in Patients With Advanced Cancer With MTAP Loss
- ClinicalTrials.gov ID
- NCT07382544
- Acronym / sponsor ID
- 2025-1200
- Conditions
- Advanced Cancer, Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- 31 Jan 2030 (estimated)
- Study completion
- 31 Jan 2032 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn about the safety and effects of BMS-986504 in combination with olaparib in patients with advanced solid tumors with MTAP loss.
Detailed description
Primary Objective:
- To determine the safety and tolerability of BMS-986504 in combination with olaparib in patients with advanced solid tumors with MTAP loss.
Secondary Objectives:
- To characterize the PK profile of BMS-986504 in combination with olaparib in patients with advanced solid tumors with MTAP loss.
- To determine the preliminary antitumor activity of BMS-986504 in combination with olaparib with advanced solid tumors with MTAP loss.
- To evaluate the pharmacodynamic activity of BMS-986504 in combination with olaparib in advanced solid tumors with MTAP loss.
- To evaluate predictors of response and resistance to BMS-986504 in combination with olaparib in patients with advanced solid tumors with MTAP loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A Dose Escalation: Treatment with BMS-986504 + Olaparib | Experimental | Drug: MRTX1719, Drug: OlaparibStudy treatment will be administered on an outpatient basis |
| Part B Pharmacodynamic Expansion Cohort 1: Treatment with BMS-986504 at C1D1 + Olaparib at C1D15 | Experimental | Drug: MRTX1719, Drug: OlaparibStudy treatment will be administered on an outpatient basis |
| Part B Pharmacodynamic Expansion Cohort 2: Treatment with Olaparib at C1D1 + BMS-986504 at C1D15 | Experimental | Drug: MRTX1719, Drug: OlaparibStudy treatment will be administered on an outpatient basis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Age ≥18 years.
- All patients must have a histologically confirmed advanced or metastatic solid tumor that has been refractory to standard therapy or are not eligible for standard therapy and have no alternative curative-intent treatment options at the time of patient enrollment. For the dose escalation, any solid tumor is eligible, but enrollment will be enriched for CCA and pancreatic cancer. For the pharmacodynamic expansion, patients must have histologically confirmed advanced or metastatic CCA or pancreatic cancer.
- Homozygous deletion of MTAP as detected by Clinical Laboratory Improvement Amendmentscertified next-generation sequencing test or absence of MTAP protein as detected by CLIAcertified immunohistochemistry test.
- Patients in Part A must have archived tumor tissue available for retrospective analysis or agree to pre-treatment biopsy.
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (14 listed)
- Part B only: Prior treatment with a PRMT5 or methionine adenosyltransferase 2A inhibitor.
- Patients who have a known additional malignancy that is progressing or requires active treatment at time of study treatment initiation. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, and in situ cervical cancer.
- Patients with meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, or symptomatic or unstable brain metastases. Note: Patients with stable brain metastases (defined as asymptomatic or no requirement for high-dose or increasing dose of systemic corticosteroids and without imminent need of radiation therapy) are eligible (including those with untreated brain metastases). If applicable, patients must have completed brain radiation therapy and recovered adequately from any associated toxicity and/or complications prior to eligibility assessment.
- Concomitant use of strong cytochrome P450 (CYP)3A inhibitors or inducers are prohibited within 14 days or 5 half-lives, whichever is longer, prior to study treatment initiation and during the study treatment period. For a comprehensive list of CYP3A inhibitors/inducers, refer to: https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactionstable-substrates-inhibitors-and-inducers.
- Any clinically significant comorbidities such as uncontrolled pulmonary disease, known impaired cardiac function or clinically significant cardiac disease (including but not limited to known left ventricular ejection fraction < 50%, congenital long QT syndrome, corrected QT interval using Fridericia's formula ≥ 480 msec on screening electrocardiogram [ECG], unstable angina pectoris ≤ 3 months prior to study treatment initiation, and acute myocardial infarction ≤ 3 months prior to study treatment initiation), or any other condition that could compromise the patient's participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRTX1719Given by mouth | Drug | Part A Dose Escalation: Treatment with BMS-986504 + Olaparib, Part B Pharmacodynamic Expansion Cohort 1: Treatment with BMS-986504 at C1D1 + Olaparib at C1D15, Part B Pharmacodynamic Expansion Cohort 2: Treatment with Olaparib at C1D1 + BMS-986504 at C1D15 |
| OlaparibAlso: LynparzaGiven by mouth | Drug | Part A Dose Escalation: Treatment with BMS-986504 + Olaparib, Part B Pharmacodynamic Expansion Cohort 1: Treatment with BMS-986504 at C1D1 + Olaparib at C1D15, Part B Pharmacodynamic Expansion Cohort 2: Treatment with Olaparib at C1D1 + BMS-986504 at C1D15 |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jordi Rodon Ahnert, MD, PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MRTX1719 and Olaparib in people with Advanced Cancer and Solid Tumor, 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 28 inclusion and 14 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 12 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 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.
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 Jordi Rodon Ahnert, MD, PHD ((713) 792-5603, jrodon@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?
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 12 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.