RecruitingPhase 1Phase 2NCT07468071

Rollover Study for Participants Who Have Been Treated With and Are Continuing to Benefit From Opnurasib as a Single Agent or in Combination With Other Study Treatments

KontRASt-R: An Open-label, Multi-center, Rollover Study for Participants Who Have Been Previously Enrolled Into a Novartis-sponsored Opnurasib (JDQ443) Study and Are Continuing to Benefit From Opnurasib as a Single Agent or in Combination With Other Study Treatments


Sponsor

Novartis Pharmaceuticals

Enrollment

40 participants

Start Date

Jun 8, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to allow continued access to opnurasib (JDQ443) to participants who are benefitting from treatment with opnurasib as a single agent or in combination with other study treatments in pre-defined Novartis-sponsored opnurasib studies and to continue to assess safety in these participants.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria3

  • Participant is currently enrolled in a pre-defined Novartis-sponsored study and is receiving opnurasib as single agent or in combination with other study treatment.
  • Participant has received at least 6 cycles of opnurasib in a parent study.
  • Participant is currently deriving clinical benefit from the study treatment, as determined by the Investigator.

Exclusion Criteria2

  • Participant has been permanently discontinued from opnurasib in the parent protocol for any reason other than enrollment in the CJDQ443B12105B study.
  • Participant currently has unresolved toxicities for which opnurasib dosing has been interrupted in the parent study.

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Interventions

DRUGOpnurasib

Eligible participants will receive the same starting dose and regimen of opnurasib as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.

DRUGTNO155

Eligible participants will receive the same starting dose and regimen of any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.

DRUGtrametinib

Eligible participants will receive the same starting dose and regimen of any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.

BIOLOGICALcetuximab

Eligible participants will receive the same starting dose and regimen of any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.

BIOLOGICALtislelizumab

Eligible participants will receive the same starting dose and regimen of any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.


Locations(1)

Novartis Investigative Site

Seoul, South Korea

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NCT07468071