Table 2.
Recruiting and ongoing clinical trials of chemotherapy-based regimens in pancreatic cancer
| Trial | Phase | Patient Population | Intervention | Primary Endpoint |
|---|---|---|---|---|
| ALLIANCE A021806 [36] | 3 | RPCa | Neoadjuvant mFOLFIRINOX + subsequent Adjuvant mFOLFIRINOX vs. Upfront Surgery + subsequent Adjuvant mFOLFIRINOX | OSb |
| NeoPancOne [244] | 2 | RPC | Measure GATA6 expression via biopsy + subsequent mFOLFIRINOX + subsequent Surgery + subsequent mFOLFIRINOX | DFSc in RPC treated with peri-operative mFOLFIRINOX according to baseline tumour GATA6 expression level |
| APOLLO EA2192 [125] | 2 | Resected pancreatic cancer and a pathogenic BRCA1, BRCA2, or PALB2 mutation | Olaparib vs. Curative-intent resection + subsequent placebo + subsequent ≥ three months of multi-agent chemotherapy | RFSd |
| PANCREAS [245] | 2 | RPC or BRPCe | Classical vs. basal transcriptional profiling.Classical subtype will be assigned to mFOLFIRINOX and basal-like tumours will be assigned to Gemcitabine + Nab-paclitaxel | Composite clinical response, CA19-9 decline, and performance status |
| PREOPANC-3 [246] | 3 | RPC | Neoadjuvant mFOLFIRINOX + subsequent Surgery + Adjuvant mFOLFIRINOX vs. Surgery + subsequent Adjuvant mFOLFIRINOX | OS |
| NCT05630183 [210] | 2 | mPDAC who have progressed on prior FOLFIRINOX | Botensilimab + Nab-paclitaxel + Gemcitabine vs. Nab-paclitaxel + Gemcitabine | Efficacy |
| CheMo4METPANC [211] | 2 | mPDAC | Gemcitabine + Nab-paclitaxel + Chemokine Motif Receptor 4 Inhibitor (Motixafortide) + Immune Checkpoint Blockade (Cemiplimab) vs. Gemcitabine + Nab-paclitaxel | PFSf |
| ARC-8 [247] | 1 | mPDAC | AB680 (CD73 Inhibitor) + Zimberelimab (PD-1 Inhibitor) +Nab-paclitaxel + Gemcitabine | Safety, tolerability, pharmacokinetic, pharmacodynamic and clinical activity |
| NCT06179160 [163] | 1 | mPDAC | INCB161734 monotherapy vs. INCB161734 combination therapies, including + mFOLFIRINOX or + Gemcitabine + Nab-paclitaxel | Safety |
| RMC-GI-102 (NCT06445062) [248] | 1/2 | KRASG12D Mutated mPDAC | Daraxonrasib + Gemcitabine + Nab-paclitaxel | Safety, tolerability, pharmacokinetics, and preliminary antitumour activity |
| NCT05382559 [249] | 1 | KRASG12D Mutated mPDAC | ASP3082 monotherapy or in combination with mFOLFIRINOX | Safety |
| NCT07409272 [250] | 3 | KRASG12D Mutated mPDAC | Setidegrasib + mFOLFIRINOX or NALIRIFOX | OS |
| NCT04794699 [251] | 1 | MTAP-deleted mPDAC | IDE397 (MAT2A Inhibitor) monotherapy or +chemotherapy or + ADCg | Safety, pharmacokinetics, pharmacodynamics |
| NCT06792435 [252] | 2 | CLDN18.2-postive mPDAC | XNW27011 (Topoisomerase Inhibitor-based ADC targeting CLDN18.2h) | Safety and efficacy |
| TWINPEAK Study [253] | 1/2 | mPDAC | Spevatamig (PT886, IgG1-based bispecific antibody targeting CLDN18.2 and CD47) monotherapy + Gemcitabine + Nab-paclitaxel | Safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy |
aRPC, Resectable Pancreatic Cancer; bOS, Overall Survival; cDFS, Disease Free Survival; dRFS, Relapse Free Survival; eBRPC, Borderline Resectable Pancreatic Cancer; fPFS, Progression Free Survival; gADC, Antibody-drug Conjugate; hCLD18.2, Claudin 18.2