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NCT06922591 | NOT YET RECRUITING | PDAC

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

Tango Therapeutics, Inc.

Brief Summary:

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 or RMC-9805. The study comprises a dose escalation phase and a dose expansion phase.

Condition or disease

PDAC

PDAC - Pancreatic Ductal Adenocarcinoma

NSCLC

RAS Mutation

MTPAP Deletion

Lung Cancer

Pancreatic Cancer Metastatic

Thoracic Cancer

Intervention/treatment

TNG462

RMC-9805

RMC-6236

Phase

PHASE1

PHASE2

Detailed Description:

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 or RMC-9805. The study will be conducted in patients with MTAP loss and RAS mutant metastatic pancreatic adenocarcinoma (PDAC) or locally advanced or metastatic non-small cell lung cancer (NSCLC) in 2 parts: Phase 1 (dose escalation) and Phase 2 (dose expansion). Individual Arms in the dose expansion phase may open once the MTD and/or RD(s) has been determined for the corresponding combination in the dose escalation phase of the study.

Study Type : INTERVENTIONAL
Estimated Enrollment : 133 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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 or Non-Small Cell Lung Cancer With MTAP Loss & RAS Mutation
Actual Study Start Date : 2025-06
Estimated Primary Completion Date : 2027-06
Estimated Study Completion Date : 2027-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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. 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. 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. Prior enrollment in any phase 3 clinical trial of RMC-6236 or RMC-9805
  • 3. Known allergy, hypersensitivity or intolerance to TNG462, RMC-6236, RMC-9805 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 to Evaluate the Safety, Tolerability & Efficacy of TNG462 in Combination in PDAC & NSCLC Patients

Location Details

NCT06922591

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