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 + leucovorin is an investigational small molecule combination being studied for the treatment of colorectal cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The combination is being evaluated for safety, pharmacokinetics, and efficacy in patients with colorectal cancer.
NUC-3373 + leucovorin is being developed by NuCana plc, a biopharmaceutical company listed on the stock exchange under the ticker NCNA. The company is conducting clinical trials to evaluate this combination therapy for colorectal cancer.
NUC-3373 + leucovorin is in Phase 1 clinical development. It is an investigational drug combination and has not been approved by the FDA or other regulatory agencies. The Phase 1 trial has been completed, and the combination remains under investigation for colorectal cancer.
NUC-3373 + leucovorin has been studied in one completed Phase 1 clinical trial, identified as NCT03428958. This trial was a safety, pharmacokinetic, and efficacy study of NUC-3373 in combination with standard agents used in colorectal cancer treatment, enrolling 111 participants across the United States, France, and the United Kingdom.
NUC-3373 + leucovorin is a combination regimen that includes NUC-3373 and leucovorin. NUC-3373 is the investigational drug being studied, and leucovorin is a standard agent used in colorectal cancer treatment. The combination is being evaluated in clinical trials for colorectal cancer.