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Tests treatment safety and results for PDAC
Official title Study to Evaluate the Safety, Tolerability & Efficacy of TNG462 in Combination in PDAC & NSCLC Patients
ClinicalTrials.gov ID: NCT06922591
What this study is testing
What is TNG462?
TNG462 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for pdac.
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
- TNG462-C102 is a Phase 1/2, open-label, multicenter study designed to determine the safety, tolerability, PK, PD, and preliminary antineoplastic activity of oral TNG462 in combination with RMC-6236, RMC-9805, mFOLFIRINOX or gemcitabine/nab-paclitaxel. The study comprises a dose escalation phase and a dose expansion phase.
- 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
- Is ≥18 years of age at the time of signature of the main study ICF.
- Has an ECOG PS of 0 or 1.
- Has a tumor with loss of MTAP protein or bi-allelic deletion of the MTAP gene
- Arms A and B only: Has a tumor with a RAS mutation
- Pathologically documented metastatic PDAC or locally advanced, recurrent or metastatic NSCLC
You likely can't join if
- Has received prior treatment with a PRMT5 inhibitor, or MAT2A inhibitor
- Arms A and B only: Prior enrollment in any phase 3 clinical trial of RMC-6236 or RMC-9805
- Known allergy, hypersensitivity or intolerance to TNG462 (all arms), RMC-6236 Arm A), RMC-9805 (Arm B), mFOLFIRINOX (Arm C)...
- Has uncontrolled intercurrent illness that will limit compliance with the study requirements.
- Has an active infection requiring systemic therapy.
- Is currently participating in or has planned concurrent participation in a study of another investigational agent or device.
See the full eligibility criteria
- Is ≥18 years of age at the time of signature of the main study ICF.
- Has an ECOG PS of 0 or 1.
- Has a tumor with loss of MTAP protein or bi-allelic deletion of the MTAP gene
- Arms A and B only: Has a tumor with a RAS mutation
- Pathologically documented metastatic PDAC or locally advanced, recurrent or metastatic NSCLC
- Has received prior standard therapy
- Arms A and B only: Must not have received prior RAS-targeted therapy
- Has evidence of measurable disease based on RECIST v1.1.
- Adequate organ function
- Must be able to swallow tablets.
- Negative pregnancy test at screening
- Written informed consent must be obtained according to local guidelines
- Has received prior treatment with a PRMT5 inhibitor, or MAT2A inhibitor
- Arms A and B only: Prior enrollment in any phase 3 clinical trial of RMC-6236 or RMC-9805
- Known allergy, hypersensitivity or intolerance to TNG462 (all arms), RMC-6236 Arm A), RMC-9805 (Arm B), mFOLFIRINOX (Arm C), gemcitabine/nab-paclitaxel (Arm D) or their excipients
- Has uncontrolled intercurrent illness that will limit compliance with the study requirements.
- Has an active infection requiring systemic therapy.
- Is currently participating in or has planned concurrent participation in a study of another investigational agent or device.
- Has impairment of GI function or disease that may significantly alter the absorption of the oral medications
- Has known or suspected active or untreated CNS metastases associated with progressive neurological symptoms
- Has current active liver disease from any cause
- Is known to be HIV positive, unless all the following criteria are met:
- CD4+ count ≥300/µL.
- Undetectable viral load.
- Receiving highly active antiretroviral therapy
- Has clinically relevant cardiovascular disease
- History of or presence of active interstitial lung disease
- Is a female patient who is pregnant or lactating
- Is unwilling or unable to comply with the scheduled visits, study treatment administration plan, laboratory tests or other study procedures and study restrictions.
- Has a prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion may affect the safety of the patient or impair...
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Denver, Colorado, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Houston, Texas, United States
- Irving, 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 - 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?
Study sites include Scottsdale, Arizona, United States; Denver, Colorado, United States; Washington D.C., District of Columbia, United States; Jacksonville, Florida, United States; Chicago, Illinois, United States; Indianapolis, Indiana, United States and 10 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.