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Tests treatment safety and results for Advanced Malignant Solid Neoplasm
Official title Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness
ClinicalTrials.gov ID: NCT05691491
What this study is testing
What is Temozolomide?
Temozolomide is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for advanced malignant solid neoplasm.
Also referred to as CCRG-81045, Gliotem.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase I/II trial studies the side effects and best dose of temozolomide and M1774 and how well they works in treating patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and may have spread to nearby tissue, lymph nodes, or distant parts of the body (advanced). Temozolomide is in a class of medications called alkylating agents.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have histologically or cytologically confirmed diagnosis of metastatic advanced cancer.
- In dose escalation, any solid tumor patients with either O6-methylguanine DNA methyltransferase (MGMT) promoter hypermethylation positivity on...
- In phase 2, only patients with mismatch repair proficient / microsatellite stable colorectal cancer that have MGMT promoter hypermethylation...
- In dose escalation, patients must have progressed after treatment with all available therapies including immunotherapies for metastatic disease that...
- For patients with mismatch repair proficient / microsatellite stable colorectal cancer in the phase 2 portion, patients must have received prior...
You likely can't join if
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception...
- History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to M1774 or temozolomide...
- Patients with uncontrolled intercurrent illness.
- Pregnant women are excluded from this study because M1774 is an ATR inhibiting agent with the potential for teratogenic or abortifacient effects...
- Patients with a prior history of ataxia telangiectasia.
- Patients who are not able to swallow orally administered medication or have gastrointestinal disorders likely to interfere with absorption of the...
See the full eligibility criteria
Who can join
- Patients must have histologically or cytologically confirmed diagnosis of metastatic advanced cancer.
- In dose escalation, any solid tumor patients with either O6-methylguanine DNA methyltransferase (MGMT) promoter hypermethylation positivity on testing / pre-screening of archival tissue OR an extracranial solid tumor...
- In phase 2, only patients with mismatch repair proficient / microsatellite stable colorectal cancer that have MGMT promoter hypermethylation positivity on pre-screening of archival tissue will be eligible.
- In dose escalation, patients must have progressed after treatment with all available therapies including immunotherapies for metastatic disease that are known to confer clinical benefit, or are intolerant to treatment...
- For patients with mismatch repair proficient / microsatellite stable colorectal cancer in the phase 2 portion, patients must have received prior therapy with 1 or more systemic therapies in the metastatic setting that...
- Age \>=18 years. Because no dosing or adverse event data are currently available on the use of M1774 in combination with temozolomide in patients \< 18 years of age, children are excluded from this study.
- Measurable disease on CT and/or MRI per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status =\ = 60%).
- Hemoglobin \>=10 g/dL (No blood transfusions are allowed within 14 days of cycle 1 day 1 [C1D1]).
- White blood cells (WBC) \> 3 x 10\^9/L.
- Absolute neutrophil count \>= 1,500/mcL.
- Platelets \>= 100,000/mcL.
- Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN).
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine-aminotransferase (ALT) (serum glutamic-pyruvic transaminase [SGPT]) =\< 3 x institutional ULN except for when liver metastases...
- Glomerular filtration rate (GFR) \>= 60 mL/min/1.73 m\^2.
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral...
- Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for 4 weeks.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- 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...
- The effects of M1774 on the developing human fetus are unknown. For this reason and because ATR inhibitors agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of...
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- 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, which may be =\< grade 2.
- History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to M1774 or temozolomide, including dacarbazine.
- Patients with uncontrolled intercurrent illness.
- Pregnant women are excluded from this study because M1774 is an ATR inhibiting agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in...
- Patients with a prior history of ataxia telangiectasia.
- Patients who are not able to swallow orally administered medication or have gastrointestinal disorders likely to interfere with absorption of the study medication.
- Patients who cannot discontinue proton-pump inhibitors (PPIs) while taking M1774. H-2 receptor antagonists are allowed but should not be taken within 12 hours before or 2 hours after M1774. Antacids are also allowed...
- Extensive RT involving greater than 30% of the bone marrow is not permitted during the study.
- A Fridericia's correction formula (QTcF) \> 480 ms is exclusionary given the potential for QT.
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
- La Jolla, California, United States
- Orange, California, United States
- New Haven, Connecticut, United States
- Trumbull, Connecticut, United States
- Shiloh, Illinois, United States
- Fairway, Kansas, United States
- Kansas City, Kansas, United States
- Overland Park, Kansas, United States
- Westwood, Kansas, United States
- Bethesda, Maryland, United States
- City of Saint Peters, Missouri, United States
- Creve Coeur, Missouri, United States
- Kansas City, Missouri, United States
- Lee's Summit, Missouri, United States
- North Kansas City, Missouri, United States
- St Louis, Missouri, United States
- Oklahoma City, Oklahoma, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Irvine, California, United States; La Jolla, California, United States; Orange, California, United States; New Haven, Connecticut, United States; Trumbull, Connecticut, United States; Shiloh, Illinois, United States and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.