NSCLCPhase 1/2NCT05546268
Study of Oral MRT-2359 in Selected Cancer Patients
A Phase 1/2 study testing Oral MRT-2359 in people with NSCLC and SCLC, run by Monte Rosa Therapeutics, Inc at 17 sites in United States.
Trial summary
This Phase 1/2, open-label, multicenter study is conducted in patients with previously treated selected solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), high-grade neuroendocrine cancer of any primary site, diffuse large B-cell lymphoma (DLBCL), and tumors with L-MYC or N-MYC… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC, SCLC, High Grade Neuroendocrine Cancer
- What is being tested?
- Oral MRT-2359
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 17 sitesUnited States
- Study dates
- 12 Oct 2022to Nov 2027
- 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
None listed.
Who cannot join
- Have received prior chemotherapy, definitive radiation, biological cancer therapy or any investigational agent within 21 days before the first dose of study treatment, or have any AEs that have failed to recover to baseline. In patients with prostate cancer, continuance of systemic therapies to maintain castration levels of testosterone is allowed. Pre-menopausal patients with hormone-dependent breast cancer can continue on therapies used for suppression of ovarian function.
- Have received bisphosphonates or denosumab within 14 days before the first administration of the study drug unless they were given for acute hypercalcemia
- Inability to swallow oral medication
- Have received prior therapy with a GSPT1 degrader that was discontinued due to an AE
- Have received prior auto-HCT and not fully recovered from effects of the last transplant
- Have received prior allogeneic hematopoietic stem cell transplantation within past 6 months and/or have symptoms of graft-versus-host disease. Patients requiring minimal intervention such as topical steroids are eligible
Show all 17Show fewer
- Have received a live vaccine within 90 days before the first dose of study treatment
- COVID-19 immunization within 14 days of receiving the first dose of MRT-2359
- Current use of chronic systemic steroid therapy in excess of replacement doses (prednisone ≤ 10 mg/day is acceptable)
- Have clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug
- Have a history of a second malignancy, unless controlled not requiring therapy
- Have clinically active central nervous system involvement and/or carcinomatous meningitis. Patients with treated and stable brain metastases (not progressing for at least 4 weeks prior to enrollment) not requiring steroids are eligible
- Have a confirmed history of (non-infectious) pneumonitis that required steroids
- Have known human immunodeficiency virus (HIV) unless the patient is on antiviral therapy with undetectable HIV RNA levels
- Have known hepatitis B or C infection(s) unless treated with undetectable hepatitis B DNA or hepatitis C RNA levels
- Clinically significant cardiac disease
- Be pregnant or breastfeeding
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Mary Crowley Cancer Research
Dallas, Texas, 75251
Henry Ford Cancer Institute
Detroit, Michigan, 48202
Virginia Cancer Specialists Research Institute
Fairfax, Virginia, 22031
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan, 49546
MD Anderson Cancer Center
Houston, Texas, 77030-4009
University of Kansas Cancer Center
Lawrence, Kansas, 66044
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Yale University
New Haven, Connecticut, 06520
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Columbia University Irving Medical Centre
New York, New York, 10032
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, 78229
University of California San Diego
San Diego, California, 92037
Honor Health Research Institute
Scottsdale, Arizona, 85258
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Washington University
St Louis, Missouri, 63110
South Texas Accelerated Research Therapeutics (START) Mountain Region
West Valley City, Utah, 84119
About this study
Official title: A Phase 1/2 Study of Oral MRT-2359 in Patients With MYC-Driven and Other Selected Solid Tumors Including Lung Cancer and Diffuse B-Cell Lymphoma
This Phase 1/2, open-label, multicenter study is conducted in patients with previously treated selected solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), high-grade neuroendocrine cancer of any primary site, diffuse large B-cell lymphoma (DLBCL), and tumors with L-MYC or N-MYC amplification. Patients receive escalating doses of a GSPT1 molecular glue degrader MRT-2359 to determine safety, tolerability, maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of MRT-2359. Once the MTD and/or RP2D is identified, additional patients enroll to Phase 2 study, which includes molecular biomarkers stratification or selection, namely expression or amplification of L-MYC and N-MYC genes, hormone receptor positive (HR)-positive, human epidermal growth factor 2 (HER2)-negative breast cancer and prostate cancer.
Read the detailed description
This Phase 1/2, open-label, multicenter, dose escalation and expansion study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary clinical activity of MRT-2359 in patients with previously treated selected solid tumors, including lung cancer (NSCLC and SCLC), high-grade neuroendocrine cancer of any primary site, and DLBCL.
- The primary aim of Phase 1 part is safety, tolerability, MTD and/or RP2D of MRT-2359.
- The primary aim of Phase 2 part is assessment of preliminary anti-tumor activity of MRT-2359.
- Conditions
- NSCLC, SCLC, High Grade Neuroendocrine Cancer, DLBCL, L-MYC and N-MYC Amplified Solid Tumors, NSCLC With High or Low L-MYC or N-MYC Expression
- Being tested
- Oral MRT-2359
- Keywords
- Small Cell Lung Cancer, Non-Small Cell Lung Cancer, L-MYC Amplification, N-MYC Amplification, L-MYC expression, N-MYC expression, High-grade neuroendocrine, Diffuse Large B-Cell Lymphoma, Molecular glue degrader, Anti-tumor, GSPT1, HR-positive, HER2-negative, Breast Cancer, Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms, Small Cell Lung Carcinoma, Carcinoma, Non-Small-Cell Lung, Lymphoma, Large B-Cell, Diffuse, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral MRT-2359Drug
Orally administered tablets of MRT-2359.
Oral MRT-2359Drug
Orally administered tablets of MRT-2359.
Oral MRT-2359Drug
Orally administered tablets of MRT-2359.
Oral MRT-2359Drug
Orally administered tablets of MRT-2359.
Oral MRT-2359Drug
Orally administered tablets of MRT-2359 in conjunction with intramuscular administration of fulvestrant.
Oral MRT-2359Drug
Orally administered tablets of MRT-2359 in conjunction with orally administered enzalutamide.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Dose Escalation | Experimental | Patients with NSCLC, SCLC, high-grade neuroendocrine cancer of any primary site, any solid tumors with L-MYC or N-MYC amplification, or DLBCL Receives: Drug: Oral MRT-2359 |
| Phase 2 Expansion - NSCLC | Experimental | Patients with NSCLC with high or low L-MYC or N-MYC expression Receives: Drug: Oral MRT-2359 |
| Phase 2 Expansion - SCLC | Experimental | Patients with SCLC Receives: Drug: Oral MRT-2359 |
| Phase 2 Expansion - L-MYC or N-MYC amplified solid tumors | Experimental | Patients with L-MYC or N-MYC amplified solid tumors Receives: Drug: Oral MRT-2359 |
| Phase 2 Expansion - HR-positive, HER2-negative breast cancer | Experimental | Patients with HR-positive, HER2-negative breast cancer in combination with fulvestrant Receives: Drug: Oral MRT-2359 |
| Phase 2 Expansion - Prostate Cancer | Experimental | Patients with prostate cancer in combination with enzalutamide Receives: Drug: Oral MRT-2359 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 Evaluates safety and tolerability of MRT-2359 over a 28-day cycle by the occurrence and frequency of dose limiting toxicities (DLTs) for determination of the MTD and/or RP2D
Measured: 28 days
Phase 2 Evaluates preliminary anti-tumor activity of MRT-2359 by overall response rate (ORR) as determined by RECIST 1.1
Measured: 56 days (up to approximately 24 months from screening to end of study participation
Secondary outcomes (11)
Phase 1 safety and tolerability of MRT-2359 (orally over a 28-day cycle) by the nature, incidence, and severity of all treatment-emergent adverse events (TEAEs), including treatment-related TEAEs and serious adverse events (SAEs)
Measured: 18 months
Phase 1 preliminary anti-tumor activity: ORR (RECIST 1.1/Revised Response Criteria for Malignant Lymphoma),duration of response for complete response(CR)/partial response(PR), disease control rate, progression-free survival, overall survival
Measured: 18 months
Phase 1 Dose Escalation characterizes the PK profile of MRT-2359 by standard primary PK parameters including, but not limited to, AUC, Cmax, tmax, and t1/2
Measured: 28 days
Phase 1 Dose Escalation evaluates the effect of a high-fat meal on the relative bioavailability of MRT-2359 by standard primary PK parameters including, but not limited to, AUC and Cmax
Measured: 7 days
Phase 2 Dose Expansion evaluates the safety and tolerability of MRT-2359 administered orally over a 28-day cycle by the nature, incidence, and severity of all TEAEs, including treatment-related TEAEs and SAEs according to the NCI CTCAE, version 5.0
Measured: 24 months
Phase 2 Dose Expansion evaluates additional measures of the preliminary anti-tumor activity of MRT-2359 such as DoR (in patients with the best overall response of CR or PR)
Measured: 24 months
Phase 2 Dose Expansion further characterizes the PK profile of MRT-2359 by evaluating MRT-2359 plasma concentration to establish PK parameters including, but not limited to, Cmax, tmax, AUC0-t, AUC0inf, mean residence time, accumulation ratio, etc.
Measured: 28 days
Phase 2 Dose Expansion evaluates additional measures of the preliminary anti-tumor activity of MRT-2359 such as DCR
Measured: 24 months
Phase 2 Dose Expansion evaluates additional measures of the preliminary anti-tumor activity of MRT-2359 such as PFS
Measured: 24 months
Phase 2 Dose Expansion evaluates additional measures of the preliminary anti-tumor activity of MRT-2359 such as OS
Measured: 24 months
Phase 2 Dose Expansion evaluates additional measures of the preliminary anti-tumor activity of MRT-2359 such as PSA response
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start12 Oct 2022
- Primary completionDec 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Single Group
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monte Rosa Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546268
- Sponsor's protocol ID
- MRT-2359-001
- Status last verified
- Nov 2026
- First submitted
- 16 Sep 2022
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of Oral MRT-2359 in Patients With MYC-Driven and Other Selected Solid Tumors Including Lung Cancer and Diffuse B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT05546268
- Acronym / sponsor ID
- MRT-2359-001
- Conditions
- NSCLC, SCLC, High Grade Neuroendocrine Cancer, DLBCL, L-MYC and N-MYC Amplified Solid Tumors, NSCLC With High or Low L-MYC or N-MYC Expression
- Keywords
- Small Cell Lung Cancer, Non-Small Cell Lung Cancer, L-MYC Amplification, N-MYC Amplification, L-MYC expression, N-MYC expression, High-grade neuroendocrine, Diffuse Large B-Cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Monte Rosa Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 19 Sep 2022 (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.
This Phase 1/2, open-label, multicenter study is conducted in patients with previously treated selected solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), high-grade neuroendocrine cancer of any primary site, diffuse large B-cell lymphoma (DLBCL), and tumors with L-MYC or N-MYC amplification. Patients receive escalating doses of a GSPT1 molecular glue degrader MRT-2359 to determine safety, tolerability, maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of MRT-2359. Once the MTD and/or RP2D is identified, additional patients enroll to Phase 2 study, which includes molecular biomarkers stratification or selection, namely expression or amplification of L-MYC and N-MYC genes, hormone receptor positive (HR)-positive, human epidermal growth factor 2 (HER2)-negative breast cancer and prostate cancer.
Detailed description
This Phase 1/2, open-label, multicenter, dose escalation and expansion study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary clinical activity of MRT-2359 in patients with previously treated selected solid tumors, including lung cancer (NSCLC and SCLC), high-grade neuroendocrine cancer of any primary site, and DLBCL.
- The primary aim of Phase 1 part is safety, tolerability, MTD and/or RP2D of MRT-2359.
- The primary aim of Phase 2 part is assessment of preliminary anti-tumor activity of MRT-2359.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Single Group
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Dose Escalation | Experimental | Drug: Oral MRT-2359Patients with NSCLC, SCLC, high-grade neuroendocrine cancer of any primary site, any solid tumors with L-MYC or N-MYC amplification, or DLBCL |
| Phase 2 Expansion - NSCLC | Experimental | Drug: Oral MRT-2359Patients with NSCLC with high or low L-MYC or N-MYC expression |
| Phase 2 Expansion - SCLC | Experimental | Drug: Oral MRT-2359Patients with SCLC |
| Phase 2 Expansion - L-MYC or N-MYC amplified solid tumors | Experimental | Drug: Oral MRT-2359Patients with L-MYC or N-MYC amplified solid tumors |
| Phase 2 Expansion - HR-positive, HER2-negative breast cancer | Experimental | Drug: Oral MRT-2359Patients with HR-positive, HER2-negative breast cancer in combination with fulvestrant |
| Phase 2 Expansion - Prostate Cancer | Experimental | Drug: Oral MRT-2359Patients with prostate cancer in combination with enzalutamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (17 listed)
- Have received prior chemotherapy, definitive radiation, biological cancer therapy or any investigational agent within 21 days before the first dose of study treatment, or have any AEs that have failed to recover to baseline. In patients with prostate cancer, continuance of systemic therapies to maintain castration levels of testosterone is allowed. Pre-menopausal patients with hormone-dependent breast cancer can continue on therapies used for suppression of ovarian function.
- Have received bisphosphonates or denosumab within 14 days before the first administration of the study drug unless they were given for acute hypercalcemia
- Inability to swallow oral medication
- Have received prior therapy with a GSPT1 degrader that was discontinued due to an AE
- Have received prior auto-HCT and not fully recovered from effects of the last transplant
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 |
|---|---|---|
| Oral MRT-2359Orally administered tablets of MRT-2359. | Drug | Phase 1 Dose Escalation |
| Oral MRT-2359Orally administered tablets of MRT-2359. | Drug | Phase 2 Expansion - NSCLC |
| Oral MRT-2359Orally administered tablets of MRT-2359. | Drug | Phase 2 Expansion - SCLC |
| Oral MRT-2359Orally administered tablets of MRT-2359. | Drug | Phase 2 Expansion - L-MYC or N-MYC amplified solid tumors |
| Oral MRT-2359Orally administered tablets of MRT-2359 in conjunction with intramuscular administration of fulvestrant. | Drug | Phase 2 Expansion - HR-positive, HER2-negative breast cancer |
| Oral MRT-2359Orally administered tablets of MRT-2359 in conjunction with orally administered enzalutamide. | Drug | Phase 2 Expansion - Prostate Cancer |
Primary outcome
Phase 1 Evaluates safety and tolerability of MRT-2359 over a 28-day cycle by the occurrence and frequency of dose limiting toxicities (DLTs) for determination of the MTD and/or RP2D
Time frame: 28 days
Phase 2 Evaluates preliminary anti-tumor activity of MRT-2359 by overall response rate (ORR) as determined by RECIST 1.1
Time frame: 56 days (up to approximately 24 months from screening to end of study participation
11 secondary outcomes
Phase 1 safety and tolerability of MRT-2359 (orally over a 28-day cycle) by the nature, incidence, and severity of all treatment-emergent adverse events (TEAEs), including treatment-related TEAEs and serious adverse events (SAEs)
Time frame: 18 months
Phase 1 preliminary anti-tumor activity: ORR (RECIST 1.1/Revised Response Criteria for Malignant Lymphoma),duration of response for complete response(CR)/partial response(PR), disease control rate, progression-free survival, overall survival
Time frame: 18 months
Phase 1 Dose Escalation characterizes the PK profile of MRT-2359 by standard primary PK parameters including, but not limited to, AUC, Cmax, tmax, and t1/2
Time frame: 28 days
Phase 1 Dose Escalation evaluates the effect of a high-fat meal on the relative bioavailability of MRT-2359 by standard primary PK parameters including, but not limited to, AUC and Cmax
Time frame: 7 days
Phase 2 Dose Expansion evaluates the safety and tolerability of MRT-2359 administered orally over a 28-day cycle by the nature, incidence, and severity of all TEAEs, including treatment-related TEAEs and SAEs according to the NCI CTCAE, version 5.0
Time frame: 24 months
Phase 2 Dose Expansion evaluates additional measures of the preliminary anti-tumor activity of MRT-2359 such as DoR (in patients with the best overall response of CR or PR)
Time frame: 24 months
Phase 2 Dose Expansion further characterizes the PK profile of MRT-2359 by evaluating MRT-2359 plasma concentration to establish PK parameters including, but not limited to, Cmax, tmax, AUC0-t, AUC0inf, mean residence time, accumulation ratio, etc.
Time frame: 28 days
Phase 2 Dose Expansion evaluates additional measures of the preliminary anti-tumor activity of MRT-2359 such as DCR
Time frame: 24 months
Phase 2 Dose Expansion evaluates additional measures of the preliminary anti-tumor activity of MRT-2359 such as PFS
Time frame: 24 months
Phase 2 Dose Expansion evaluates additional measures of the preliminary anti-tumor activity of MRT-2359 such as OS
Time frame: 24 months
Phase 2 Dose Expansion evaluates additional measures of the preliminary anti-tumor activity of MRT-2359 such as PSA response
Time frame: 24 months
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 6 Nov 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Oral MRT-2359 in people with NSCLC and SCLC, run by Monte Rosa Therapeutics, Inc at 17 sites 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 17 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 Evaluates safety and tolerability of MRT-2359 over a 28-day cycle by the occurrence and frequency of dose limiting toxicities (DLTs) for determination of the MTD and/or RP2D (time frame: 28 days). The study lists 2 primary outcomes in all. 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 6 Nov 2026.