Non Small Cell Lung Cancer study: TNG456 vs Abemaciclib
Official title Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss
ClinicalTrials.gov ID: NCT06810544
What this study is testing
What is TNG456?
TNG456 is an investigational medicine, taken by mouth, being studied as a potential treatment for non small cell lung cancer.
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
- The study aims to learn whether TNG456, alone or combined with abemaciclib, is safe and tolerable in people with advanced or metastatic solid tumors that have lost the MTAP gene.
- Who it's for
- Adults with advanced or metastatic solid tumors (such as lung or brain cancers) that have a confirmed MTAP loss.
- What's involved
- Participants take an oral pill (TNG456) and may also take abemaciclib while doctors increase the dose to find a safe level. They will have regular clinic visits for dosing, safety checks, and lab tests.
- Time commitment
- The trial runs for several months and requires multiple clinic visits for dosing and monitoring during the dose‑escalation and expansion phases.
- Phase 2: a mid-size study of how well it works
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
- Has a tumor with a confirmed MTAP loss
- Is ≥18 years of age at the time of signature of the main study ICF
- Has had progression or an inadequate response to or is intolerant of the approved standard of care therapy, no standard of care therapy exists, or...
- Is able to swallow tablets
- Adequate Organ function/reserve per local labs
You likely can't join if
- A female patient is who is pregnant or breastfeeding
- Has impaired GI function or disease that may significantly alter the absorption of oral study treatment(s)
- Has an active infection requiring systemic therapy
- Has received prior treatment with a PRMT5 inhibitor or a MAT2A inhibitor
- Patients in the expansion receiving the combination therapy that have received prior treatment with a CDK4/6 inhibitor
- Clinically relevant cardiovascular disease
See the full eligibility criteria
- Has a tumor with a confirmed MTAP loss
- Is ≥18 years of age at the time of signature of the main study ICF
- Has had progression or an inadequate response to or is intolerant of the approved standard of care therapy, no standard of care therapy exists, or the investigator has determined that treatment with the standard of care...
- Is able to swallow tablets
- Adequate Organ function/reserve per local labs
- Negative serum pregnancy test result at screening
- Has an ECOG performance status score of 0 to 1
- Has measurable disease based on RECIST v1.1 or a confirmed glioblastoma (IDH-wildtype) with radiographic evidence of disease progression or recurrence defined by RANO 2.0.
- Has an ECOG performance score of 0 to 1 or for GBM has a Karnofsky performance status score ≥70.
- A female patient is who is pregnant or breastfeeding
- Has impaired GI function or disease that may significantly alter the absorption of oral study treatment(s)
- Has an active infection requiring systemic therapy
- Has received prior treatment with a PRMT5 inhibitor or a MAT2A inhibitor
- Patients in the expansion receiving the combination therapy that have received prior treatment with a CDK4/6 inhibitor
- Clinically relevant cardiovascular disease
- Has a prior or ongoing clinically significant illness may affect the safety of the patient, impair the assessment of study results or compliance with the protocol
The study team makes the final eligibility decision.
Where it is enrolling
- Scottsdale, Arizona, United States
- Irvine, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Fairfax, Virginia, 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, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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?
This study is enrolling now at Scottsdale, Arizona, United States; Irvine, California, United States; Los Angeles, California, United States; San Francisco, California, United States; Washington D.C., District of Columbia, United States; Jacksonville, Florida, United States and 8 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.