Navlimetostat + Pumitamig for Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine a safe and tolerable dose of two drugs, navlimetostat and pumitamig, for treating advanced non-small cell lung cancer (NSCLC) that lacks a specific protein (MTAP-deficient). Researchers seek to evaluate the effectiveness of these drugs in combination. Suitable participants have NSCLC, lack the MTAP protein, and have undergone previous cancer treatments but still have measurable disease. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, providing participants the opportunity to be among the first to receive this new treatment.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you need a medication with a known risk of Torsade's de Pointes or if it is a strong inhibitor or inducer of CYP3A4 and/or P-glycoprotein. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that navlimetostat and pumitamig have promising safety records from previous studies. Participants generally tolerated the combination well. For pumitamig, some side effects appeared, but they were mostly mild to moderate. Common side effects included tiredness, nausea, and changes in blood counts.
Navlimetostat has undergone testing in similar studies, and results suggest it is generally well-tolerated. The most common side effects were tiredness and mild stomach issues.
This combination is currently being tested in early-phase studies to determine the safe dosage and identify any serious side effects. So far, the data supports that the treatment is generally safe, but ongoing trials will provide more information.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Navlimetostat and Pumitamig because they offer a novel approach for treating non-small cell lung cancer. Most current treatments, like chemotherapy and targeted therapies, focus on disrupting cell division or specific cancer cell pathways. However, Navlimetostat and Pumitamig work differently; Navlimetostat is a small molecule inhibitor targeting a unique pathway, potentially blocking cancer cell growth, while Pumitamig is administered intravenously, complementing this action every three weeks. This combination could enhance effectiveness and limit cancer progression, providing new hope for patients where traditional therapies may fall short.
What evidence suggests that navlimetostat and pumitamig could be effective for non-small cell lung cancer?
Research has shown that combining navlimetostat and pumitamig may help treat non-small cell lung cancer (NSCLC). Early studies found that pumitamig, when used with chemotherapy, produced positive anti-tumor effects in patients with various solid tumors, including NSCLC. Trial data revealed that patients treated with pumitamig experienced a longer time before their cancer worsened. Initial findings suggest that navlimetostat might enhance these effects, as it is under study for its potential in treating MTAP-deficient cancers, a type of NSCLC. Although more research is needed, this combination is actively explored in this trial for its potential benefits in cancer treatment.23678
Who Is on the Research Team?
Natalie Vokes, MD
Principal Investigator
UT MD Anderson
Are You a Good Fit for This Trial?
This trial is for adults with advanced non-small cell lung cancer whose tumors are missing the MTAP gene. Participants should be in generally good health aside from their cancer and able to carry out daily activities.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1 Safety Lead-In
Participants receive navlimetostat orally once daily and pumitamig intravenously every 3 weeks in 21-day cycles to evaluate safety
Phase 2 Efficacy Evaluation
Participants continue receiving navlimetostat and pumitamig to evaluate efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Navlimetostat
- Pumitamig
Trial Overview
Researchers are testing a combination of two drugs, navlimetostat and pumitamig, to find the safest dose and see how well they work together in treating this specific type of lung cancer.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will receive treatment with the combination of navlimetostat, administered orally once daily (QD) combined with pumitamig, administered intravenously (IV) every 3 weeks (Q3W) in 21- day cycles until disease progression or treatment intolerance.
Participants will receive treatment with the combination of navlimetostat, administered orally once daily (QD) combined with pumitamig, administered intravenously (IV) every 3 weeks (Q3W) in 21- day cycles until disease progression or treatment intolerance.
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Citations
Ph1/2 Trial Of Navlimetostat With Pumitamig In MTAP- ...
The goal of this clinical research study is to find a safe and tolerable dose of navlimetostat in combination with pumitamig that can be ...
2.
investors.biontech.de
investors.biontech.de/news-releases/news-release-details/biontech-clinical-data-elcc-2026-highlight-potentialBioNTech Clinical Data at ELCC 2026 Highlight Potential of ...
EGFR-mutant NSCLC: Data from a Phase 2 clinical trial (NCT05756972) conducted in China showed clinically meaningful survival outcomes and a ...
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The goal of this clinical research study is to find a safe and tolerable dose of navlimetostat in combination with pumitamig that can be given to patients …
BioNTech Clinical Data at ELCC 2026 Highlight Potential ...
EGFR-mutant NSCLC: Data from a Phase 2 clinical trial (NCT05756972) conducted in China showed clinically meaningful survival outcomes and a ...
Safety and Preliminary Efficacy of Pumitamig (BNT327), an ...
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Safety and Preliminary Efficacy of Pumitamig (BNT327), an ...
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ClinicalTrials.gov. Safety and efficacy of BNT327, an investigational therapy in combination with chemotherapy for patients with untreated small ...
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