RecruitingPhase 1 / Phase 2

Study to Evaluate the Safety, Tolerability & Efficacy of TNG462 in Combination in PDAC & NSCLC Patients

A Phase 1/2, Multicenter, Open-Label Study to Evaluate Safety, Tolerability & Antitumor Activity of TNG462 in Combination With Other Agents in Patients With Pancreatic Cancer With MTAP Loss and Pancreatic or Non-Small Cell Lung Cancer With MTAP Loss & RAS Mutation

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests TNG462 tablets with other cancer drugs in adults with certain pancreatic or lung cancers. It looks at safety, side effects, how the drugs work in the body, and whether they fight cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and give written consent to join.
  • Have pancreatic cancer that has spread, or non-small cell lung cancer that has grown nearby, come back, or spread.
  • Have a tumor missing the MTAP protein or both copies of the MTAP gene.
  • For groups A and B, have a RAS gene change in the tumor and no past treatment aimed at RAS.
  • Have received standard cancer treatment and have cancer that can be measured on scans.
  • Be fully active or able to do light work, with limits only on hard physical activity.
  • Have organs that work well enough and be able to swallow tablets.
  • Have a negative pregnancy test at screening.

Who can't join

  • Past treatment with drugs that block PRMT5 or MAT2A. For groups A and B, past enrollment in a phase 3 trial of RMC-6236 or RMC-9805.
  • A known allergy or inability to tolerate the drugs or ingredients used in your study group.
  • An uncontrolled illness, an infection needing treatment throughout the body, or a digestive problem that could affect how the body takes in the tablets.
  • Known or suspected active or untreated cancer spread to the brain or spinal cord with worsening nerve-related symptoms.
  • Active liver disease, important heart or blood vessel disease, or past or current interstitial lung disease, which affects tissue around the lung’s air sacs.
  • HIV, unless the CD4 immune cell count is at least 300/µL, the virus level is too low to detect, and you are taking highly active HIV treatment.
  • Pregnancy or breastfeeding, or current or planned participation in another study of an experimental drug or device.
  • Being unable or unwilling to follow study visits, tests, treatment, or rules; or another health issue the study doctor thinks could make participation unsafe or affect the results.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Is ≥18 years of age at the time of signature of the main study ICF. 2. Has an ECOG PS of 0 or 1. 3. Has a tumor with loss of MTAP protein or bi-allelic deletion of the MTAP gene 4. Arms A and B only: Has a tumor with a RAS mutation 5. Pathologically documented metastatic PDAC or locally advanced, recurrent or metastatic NSCLC 6. Has received prior standard therapy 7. Arms A and B only: Must not have received prior RAS-targeted therapy 8. Has evidence of measurable disease based on RECIST v1.1. 9. Adequate organ function 10. Must be able to swallow tablets. 11. Negative pregnancy test at screening 12. Written informed consent must be obtained according to local guidelines Exclusion Criteria: 1. Has received prior treatment with a PRMT5 inhibitor, or MAT2A inhibitor 2. Arms A and B only: Prior enrollment in any phase 3 clinical trial of RMC-6236 or RMC-9805 3. 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 4. Has uncontrolled intercurrent illness that will limit compliance with the study requirements. 5. Has an active infection requiring systemic therapy. 6. Is currently participating in or has planned concurrent participation in a study of another investigational agent or device. 7. Has impairment of GI function or disease that may significantly alter the absorption of the oral medications 8. Has known or suspected active or untreated CNS metastases associated with progressive neurological symptoms 9. Has current active liver disease from any cause 10. Is known to be HIV positive, unless all the following criteria are met: 1. CD4+ count ≥300/µL. 2. Undetectable viral load. 3. Receiving highly active antiretroviral therapy 11. Has clinically relevant cardiovascular disease 12. History of or presence of active interstitial lung disease 13. Is a female patient who is pregnant or lactating 14. Is unwilling or unable to comply with the scheduled visits, study treatment administration plan, laboratory tests or other study procedures and study restrictions. 15. 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 ability to assess study results

Study sites (18)

AZ

CO

  • Sarah Cannon Research Institute Denver · Denver, CO 80218Gerald Falchook, MD, MS · Principal investigatorMore trials in Denver

DC

FL

IA

  • University of Iowa Health Care · Iowa City, IA 52242Naomi Fei, MD, MS · Principal investigatorMore trials in Iowa City

IL

  • Northwestern Memorial Hospital · Chicago, IL 60611-2908Chengwei Peng, MD · Principal investigatorMore trials in Chicago

IN

MA

  • Massachusetts General Hospital · Boston, MA 02114Harshabad Singh, MD · Principal investigatorMore trials in Boston
  • Dana-Farber Cancer Institute · Boston, MA 02115Kimberly Perez, MD · Principal investigatorMore trials in Boston

MN

  • Mayo Clinic Cancer Center · Rochester, MN 55905-0001Kaushal Parikh, MD · Principal investigatorMore trials in Rochester

NC

  • University of North Carolina at Chapel Hill · Chapel Hill, NC 27599-7305Shetal Patel, MD, PhD · Principal investigatorMore trials in Chapel Hill

NE

  • Nebraska Cancer Specialists · Omaha, NE 68124Joel Michalski, MD, PhD · Principal investigatorMore trials in Omaha

NY

  • NYU Langone Health · New York, NY 10016Kristen Spencer, DO, MPH · Principal investigatorMore trials in New York
  • Memorial Sloan Kettering Cancer Center · New York, NY 11065Eileen O'Reilly, MD · Principal investigatorMore trials in New York

TX

  • University of Texas MD Anderson Cancer Center · Houston, TX 77030Jordi Rodon Ahnert, MD · Principal investigatorMore trials in Houston
  • NEXT Dallas · Irving, TX 74039Siraj Sen, MD · Principal investigatorMore trials in Irving

UT

  • Huntsman Cancer Institute, University of Utah · Salt Lake City, UT 84112Vaia Florou, MD, MS · Principal investigatorMore trials in Salt Lake City

VA