A Phase 1/2, Open-Label, Multicenter Study of Oral MRT-2359 in Patients with MYC-driven and Other Selected Solid Tumors Including Lung Cancer and Diffuse Large B-Cell Lymphoma
A Phase 1/2, Open-Label, Multicenter Study of Oral MRT-2359 in Patients with MYC-driven and Other Selected Solid Tumors Including Lung Cancer and Diffuse Large B-Cell Lymphoma
NCT #
NCT05546268
Condition(s)
Non-Small Cell Lung, small-cell lung, Solid Tumors
Molecular Target(s)
GSPT1 (MYC)
Drug Classification(s)
Small Molecule
Agents(s)
MRT-2359
Phase(s)
I/II
Mechanism of Action
MRT-2359 induces degradation of GSPT1 and associated downregulation of MYC transcription factors and their transcriptional outputs, which may lead to preferential anti-proliferative activity in MYC-driven tumors.
Purpose
- How much of the study drug can be given with an acceptable level of side effects• The effects of the study drug (good and bad)
- How much of the study drug is absorbed into the blood and how fast it is removed
- How the study drug is acting on your body
- Have a selected advanced solid tumor or DLBCL for which there are no further standard therapeutic options available (L-MYC or N-MYC solid tumors preferentially NSCLC (Non-small cell lung cancer) and SCLC (Small cell lung cancer))
- A predicted life expectancy of ≥ 3 months and an ECOG performance status ≤ 2
- Have measurable disease by RECIST 1.1 (Eisenhauer et al., 2009) in case of solid tumors or Revised Response Criteria for Malignant Lymphoma (Phase 1 only) (Cheson et al., 2014) in case of DLBCL
- Have adequate organ function defined by the selected laboratory parameters
- If female of childbearing potential, avoid becoming pregnant and agree to use acceptable methods of contraception after informed consent, throughout the study, and for 90 days after the last dose of MRT-2359
- Male of reproductive potential must use an approved methods of contraception from informed consent until 90 days after study discharge
- 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
- 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
- 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
None
Location
MCD
Similar Trials
Discover more trials like this.
Trial Number
Mechanism of Action
Drug Classifications
Target Required
Conditions
Site
MCLA-128-CL01
Zenocutuzumab, a Full Length IgG1 Bispecific Antibody Targeting HER2 and HER3
n/a
NRG1 fusion
Non-Small Cell Lung, Pancreatic
MCD
MCLA-129-CL01
MCLA-129, a Human Anti-EGFR and Anti-c-MET Bispecific Antibody
n/a
EGFR, MET
esophageal Squamous Cell Carcinoma, Gastric/GEJ (Gastroesophageal Junction)/Esophageal, head and neck squamous cell carcinoma, Non-Small Cell Lung
MCD
23-27
AB801 is an AXL inhibitor
Monoclonal Antibody (Immunotherapy, Small Molecule (Targeted), targeted
STK11
Non-Small Cell Lung
MCD
Connect With Us
Whether you want to give a spark of hope or you are looking for it, we are here to help. If you have any questions or concerns, please contact us here.