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 being studied for the treatment of colorectal cancer, including colorectal neoplasms, carcinoma, and tumors. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
NUC-3373+ leucovorin is being developed by NuCana plc, a biopharmaceutical company traded on the stock exchange under the ticker symbol NCNA. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with colorectal cancer.
NUC-3373+ leucovorin is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies and is still undergoing clinical trials to assess its safety, pharmacokinetics, and efficacy in treating colorectal cancer.
NUC-3373+ leucovorin has been studied in clinical trial NCT03428958, a Phase 1 safety, pharmacokinetic, and efficacy study in combination with standard agents used in colorectal cancer treatment. This trial enrolled 111 participants and has been completed.
NUC-3373+ leucovorin is a small molecule being evaluated for its mechanism of action in treating colorectal cancer. The drug is being studied in combination with standard colorectal cancer agents to determine its safety and efficacy, though the specific molecular target has not been disclosed.