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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03428958 | A Safety, Pharmacokinetic and Efficacy Study of NUC-3373 in Combination With Standard Agents Used in Colorectal Cancer Treatment | PHASE1 | COMPLETED | 111 | — | — | Oct 5, 2018 | Mar 21, 2024 | Apr 23, 2025 | 10 | United States, France +1 |
Efficacy (per RECIST v 1.1): defined as the best percentage change from baseline in tumour size (mm)
Efficacy (per RECIST v 1.1): defined as the proportion of patients achieving confirmed response (CR and PR) or stable disease (SD) as the best overall response
Efficacy (per RECIST v 1.1): defined as the time from the time measurement criteria are first met for SD until the first date that recurrence or progressive disease (PD) is objectively documented
Efficacy (per RECIST v 1.1): defined as the time from first dose of study treatment until the date of objective disease progression or death
Efficacy: defined as the time from randomization until the date of death from any cause
Best overall response to study treatment according to RECIST v1.1
| Arm | Type | Description |
|---|---|---|
| NUC-3373 + leucovorin (LV) every other week | EXPERIMENTAL | Arm 1a: NUC-3373 administered IV followed by a 2-week washout period. The next dose of NUC-3373 administered in combination with LV at 400 mg/m2. All subsequent doses of NUC-3373 administered in combination with LV every 2 weeks in 28-day cycles. |
| NUC-3373 every other week | EXPERIMENTAL | Arm 1b: LV 400 mg/m2 administered IV over 2 hours prior to NUC-3373 infusion followed by a 2-week washout period. Then, NUC-3373 administered IV every 2 weeks without LV in 28-day cycles. |
| NUC-3373 + leucovorin (LV) weekly | EXPERIMENTAL | Arm 1c: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 administered IV weekly on Days 1, 8, 15 and 22 of 28-day cycles. |
| NUC-3373 + leucovorin (LV); combination chemotherapy ineligible | EXPERIMENTAL | Arm 1d: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 administered IV on Days 1, 8, 15 and 22 of 28-day cycles. |
| NUC-3373 + oxaliplatin weekly | EXPERIMENTAL | Arm 2a: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with oxaliplatin (85 mg/m2) administered on Days 1 and 15. |
| NUC-3373 + irinotecan weekly | EXPERIMENTAL | Arm 2b: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15. |
| NUC-3373 + oxaliplatin (NUFOX) expansion | EXPERIMENTAL | Arm 2c: At the completion of Arm 2a, the recommended dose of NUC-3373 (+LV 400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with oxaliplatin (85 mg/m2) administered on Days 1 and 15. |
| NUC-3373 + irinotecan (NUFIRI) expansion | EXPERIMENTAL | Arm 2d: At the completion of Arm 2b, the recommended dose of NUC-3373 (+LV 400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15. |
| NUFOX + bevacizumab weekly | EXPERIMENTAL | Arm 3a: NUC-3373, LV and oxaliplatin at dose levels used in Arm 2a will be combined with bevacizumab. NUC-3373+LV will be administered weekly, oxaliplatin and bevacizumab will be administered every other week. |
| NUFOX + bevacizumab every other week | EXPERIMENTAL | Arm 3b: NUC-3373, LV and oxaliplatin at dose levels used in Arm 2a will be combined with bevacizumab. NUC-3373+LV+oxaliplatin+bevacizumab will be administered every other week. |
| NUFIRI + bevacizumab weekly | EXPERIMENTAL | Arm 3c: NUC-3373, LV and irinotecan at dose levels used in Arm 2b will be combined with bevacizumab. NUC-3373+LV will be administered weekly, irinotecan and bevacizumab will be administered every other week. |
| NUFIRI + bevacizumab every other week | EXPERIMENTAL | Arm 3d: NUC-3373, LV and irinotecan at dose levels used in Arm 2b will be combined with bevacizumab. NUC-3373+LV+irinotecan+bevacizumab will be administered every other week. |
| NUC-3373 + LV + bevacizumab; maintenance patients | EXPERIMENTAL | Arm 3e: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with bevacizumab (administered every other week). |
| NUFOX + cetuximab | EXPERIMENTAL | Arm 3f: NUC-3373, LV and oxaliplatin at dose levels used in Arm 2a may be administered in subsequent cetuximab cohorts. NUC-3373+LV may be administered weekly or every other week, oxaliplatin will be administered every other week and cetuximab will be administered weekly. |
| NUFIRI + cetuximab | EXPERIMENTAL | Arm 3g: NUC-3373, LV and irinotecan at dose levels used in Arm 2b may be administered in subsequent cetuximab cohorts. NUC-3373+LV may be administered weekly or every other week, irinotecan will be administered every other week and cetuximab will be administered weekly. |
| Name | Type | Description |
|---|---|---|
| NUC-3373 + leucovorin | DRUG | NUC-3373 + leucovorin |
| NUC-3373 | DRUG | NUC-3373 |
| NUFOX | DRUG | NUC-3373 + oxaliplatin |
| NUFOX + VEGF pathway inhibitor | DRUG | NUC-3373 + oxaliplatin + bevacizumab |
| NUFOX + EGFR inhibitor | DRUG | NUC-3373 + oxaliplatin + cetuximab/panitumumab |
| NUFIRI | DRUG | NUC-3373 + irinotecan |
| NUFIRI + VEGF pathway inhibitor | DRUG | NUC-3373 + irinotecan + bevacizumab |
| NUFIRI + EGFR inhibitor | DRUG | NUC-3373 + irinotecan + cetuximab/panitumumab |
| NUC-3373 + bevacizumab | DRUG | NUC-3373 + bevacizumab |
Inclusion Criteria: All patients 1. Provision of written informed consent 2. Have histological confirmation of CRC with evidence of locally advanced/unresectable or metastatic disease 3. Age ≥18 years 4. Life expectancy of ≥12 weeks 5. ECOG Performance status 0 or 1 6. Measurable disease as define...