A Phase I/II, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Antitumor Activity of Vopimetostat in Combination With ERAS-0015 (RAS Inhibitor) in Patients With MTAP-null Pancreatic Cancer and MTAP-null Non-Small Cell Lung Cancer With RAS Mutation

Study Identifier:
TNG462-C103
CT.gov Identifier:
NCT07897734
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

TNG462-C103 is a Phase 1/2 study to investigate the safety and antitumor activity of vopimetostat (TNG462) combined with ERAS-0015 in patients with MTAP-null pancreatic or MTAP-null non-small cell lung cancer with RAS mutation.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Non-Small Cell Lung Cancer
Pancreas
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I/II
Sex
Female & Male
Age
18+ years
Study Drug
Drug: Dose Escalation PDAC: Escalating doses of vopimetostat in combination with ERAS-0015; interventions: Drug: vopimetostat, Drug: ERAS-0015. Dose expansion 1L PDAC: Expansion arm at the RD(s) of vopimetostat in combination with ERAS-0015; interventions: Drug: vopimetostat, Drug: ERAS-0015. Dose Expansion 2L PDAC: Expansion arm at the RD(s) of vopimetostat in combination with ERAS-0015; interventions: Drug: vopimetostat, Drug: ERAS-0015. Dose Expansion 2L or 3L NSCLC: Expansion arm at the RD(s) of vopimetostat in combination with ERAS-0015; interventions: Drug: vopimetostat, Drug: ERAS-0015.
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
Inclusion 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 loss of the MTAP gene, documented by a validated assay
  • 4. Has one of the following disease characteristics:
  • * 1L or 2L metastatic PDAC
  • * Locally advanced, recurrent or metastatic NSCLC (no more than 2 prior lines of therapy) with documented KRAS mutation at G12X or G13X locally obtained via an analytically validated assay (Dose expansion only).
  • 5. Has evidence of measurable disease based on RECIST v1.1.
  • 6. Adequate organ function
Exclusion criteria
  • Exclusion Criteria:
  • 1. Has received prior treatment with a PRMT5 inhibitor, MAT2A inhibitor or RAS inhibitor.
  • 2. Has an active infection requiring systemic therapy.
  • 3. Any condition that may impact the ability to take or absorb study drugs
  • 4. Has known or suspected active or untreated CNS metastases associated with progressive neurological symptoms

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Dallas Fort Worth
Fort Worth, TX, United States, 76104
Investigator
Salwan Al Mutar
Status
Recruiting
Condition(s) Treated at Site
Non-Small Cell Lung Cancer
Pancreas
Location
START New York (Long Island)
Lake Success, NY, United States, 11042
Investigator
Geraldine O'Sullivan Coyne
Status
Recruiting
Condition(s) Treated at Site
Non-Small Cell Lung Cancer
Pancreas
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Kyriakos Papadopoulos
Status
Recruiting
Condition(s) Treated at Site
Non-Small Cell Lung Cancer
Pancreas