Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NUC-3373+ leucovorin · 1 trial · 5 indications
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...
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NUC-3373 plus leucovorin is an investigational small molecule combination being studied in colorectal cancer. NUC-3373 is a nucleotide analogue developed by NuCana plc, and leucovorin is a standard agent used in colorectal cancer treatment regimens. The combination has been evaluated in a Phase 1 clinical trial.
NUC-3373 plus leucovorin is being studied for the treatment of colorectal cancer, including colorectal neoplasms, carcinoma, and tumors. It is an investigational combination and is not approved for commercial use. The clinical program enrolled adults 18 years and older with colorectal cancer across the United States, France, and the United Kingdom.
NuCana plc, which trades under the ticker NCNA, is the developer of NUC-3373. The company is evaluating NUC-3373 in combination with leucovorin and other standard agents used in colorectal cancer treatment.
NUC-3373 plus leucovorin has been studied in a Phase 1 clinical trial. The program is investigational and remains in clinical development. The Phase 1 study has been completed, and there are no active trials of this combination currently listed.
NUC-3373 plus leucovorin was evaluated in the Phase 1 trial NCT03428958, titled A Safety, Pharmacokinetic and Efficacy Study of NUC-3373 in Combination With Standard Agents Used in Colorectal Cancer Treatment. The completed study enrolled 111 participants across the United States, France, and the United Kingdom.