Table 2.
Ongoing clinical trials targeting mutations in KRAS.
| Trial ID | Tested drugs | Treatment setting | Phase | Status | Primary outcomes |
|---|---|---|---|---|---|
| NCT04117087 | KRAS peptide vaccine, nivolumab, ipilimumab | resected PDAC with KRAS mutations | I | Recruiting | Drug-related toxicities and fold change in interferon levels |
| NCT04146298 | Mutant KRAS G12V-specific TCR transduced autologous T cells, anti-PD-1 monoclonal antibody, fludarabine, cyclophosphamide | advanced PC with the KRAS G12V mutation and HLA-A*11:01 allele | I/II | Recruiting | AEs and ORR |
| NCT04132505 | Binimetinib, hydroxychloroquine | metastatic PC with KRAS mutation | I | Recruiting | MTD |
| NCT03040986 | Selumetinib sulfate | Locally advanced or metastatic PC with KRAS G12R mutation | II | Active, not recruiting | Clinical response |
| NCT03592888 | mDC3/8-KRAS vaccine | resected PDAC with KRAS mutations | I | Recruiting | Safety and side effects |
| NCT03608631 | iExosomes with KRAS G12D siRNA | metastatic PC with KRAS G12D mutation | I | Not yet recruiting | MTD and DLTs |
| NCT03948763 | mRNA-5671/V941, pembrolizumab | KRAS mutant advanced or metastatic NSCLC, CRC or PDAC | I | Recruiting | DLTs, AEs and discontinuations |
| NCT03190941 | anti-KRAS G12V mTCR, cyclophosphamide, fludarabine, aldesleukin | Metastatic unresectable malignancy with KRAS G12V mutation. | I/II | Recruiting | Response rate and AEs |
| NCT03637491 | Avelumab, binimetinib, talazoparib | metastatic PDAC or other locally advanced or metastatic solid tumors with KRAS/NRAS mutations | Ib/II | Recruiting | DLTs and objective response |
| NCT03745326 | anti-KRAS G12D mTCR PBL, cyclophosphamide, fludarabine, aldesleukin | Metastatic unresectable malignancy with KRAS G12D mutation. | I/II | Recruiting | Response rate and AEs |
| NCT04330664 | MRTX849, TNO155 | Advanced solid tumor with KRAS G12C mutation | I/II | Recruiting | AEs and pharmacokinetics |
| NCT03146962 | Vitamin C | Cohort A: resectable CRC, PC, LC; cohort B: CRC, PC, LC with KRAS/NRAS/BRAF mutations; cohort C: CRC amenable to locoregional therapy | II | Recruiting | Change in antitumor activity in cohort A; 3-month DCR in cohort B; maximal tolerated dose in cohort C |
| NCT03329248 | GI-4000 and other agents | PC with fail in standard-of –care therapy | Ib/II | Active, not recruiting | AEs and ORR |
| NCT03387098 | GI-4000 and other agents | PC with fail in standard-of –care therapy | Ib/II | Active, not recruiting | AEs and ORR |
| NCT03136406 | GI-4000 and other agents | PC with fail in standard-of –care therapy | Ib/II | Active, not recruiting | AEs and ORR |
| NCT00389610 | Allogenic GM-CSF plasmid-transfected pancreatic tumor cell vaccine | Stage I-III PDAC with surgery | II | Active, not recruiting | Local and systemic toxicities |
| NCT04121286 | JAB-3312 | Advanced solid tumors | I | Recruiting | DLTs and recommended phase II dose |
| NCT04045496 | JAB-3312 | Advanced solid tumors | I | Recruiting | DLTs and recommended phase II dose |
The data originated from https://clinicaltrials.gov (accessed July 29, 2020).
PC pancreatic cancer, AEs adverse events, ORR objective response rate, MTD maximum tolerated dose, NSCLC non-small cell lung cancer, CRC colorectal cancer, LC lung cancer, DLTs dose-limiting toxicities, DCR disease control rate.