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

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