Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07468071 | 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 | PHASE1 | NOT YET_RECRUITING | 40 | — | — | Jun 15, 2026 | Sep 17, 2029 | Apr 2, 2026 | - | — |
The number of participants enrolled and receiving opnurasib as single agent or in combination with other study treatments under the rollover study, will be summarized by treatment arm.
The duration of exposure in months to opnurasib and the combination partner will be summarized by means of descriptive statistics using the SAS.
| Arm | Type | Description |
|---|---|---|
| Group 1: opnurasib single agent | EXPERIMENTAL | 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. |
| Group 2: opnurasib + TNO155 | EXPERIMENTAL | Eligible participants will receive the same starting dose and regimen of opnurasib and 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. |
| Group 3: opnurasib + trametinib | EXPERIMENTAL | Eligible participants will receive the same starting dose and regimen of opnurasib and 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. |
| Group 4: opnurasib + cetuximab | EXPERIMENTAL | Eligible participants will receive the same starting dose and regimen of opnurasib and 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. |
| Group 5: opnurasib + tislelizumab | EXPERIMENTAL | Eligible participants will receive the same starting dose and regimen of opnurasib and 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. |
| Name | Type | Description |
|---|---|---|
| Opnurasib | DRUG | 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. |
| TNO155 | DRUG | 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. |
| trametinib | DRUG | 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. |
| cetuximab | BIOLOGICAL | 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. |
| tislelizumab | BIOLOGICAL | 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. |
Key Inclusion Criteria: * 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 deri...