Table 6.
US clinical trials using CXCR1 antagonists for cancer treatment.
| CXCR1/2 blockade | NCT Number | Title | Status | Study Results | Conditions | Interventions | Phases | Enrollment |
|---|---|---|---|---|---|---|---|---|
| Navarixin | NCT03473925 | Efficacy and Safety Study of Navarixin (MK-7123) in Combination With Pembrolizumab (MK-3475) in Adults With Selected Advanced/Metastatic Solid Tumors (MK-7123-034) | Completed | ORR up to 3.9%, PFS up to 17.5 mo in NSCLC, OS up to 13.0 mo. | Solid Tumors|Non-small Cell Lung Cancer|Castration Resistant Prostate Cancer|Microsatellite Stable Colorectal Cancer | Drug: Navarixin|Biological: Pembrolizumab | Phase 2 | 107 |
| Reparixin | NCT02001974 | Pilot Study to Evaluate Reparixin With Weekly Paclitaxel in Patients With HER 2 Negative Metastatic Breast Cancer (MBC) | Completed | Clinical Benefit Rate (CBR) up to 56.5% in group 3 combination treatment. 6mo PFS 25.0%. | Metastatic Breast Cancer | Drug: Paclitaxel+Reparixin | Phase 1 | 33 |
| NCT01861054 | Pilot Study to Evaluate Safety & Biological Effects of Orally Administered Reparixin in Early Breast Cancer | Terminated | 5% SAE due to post op infection | Breast Cancer | Drug: Reparixin | Phase 2 | 20 | |
| NCT02370238 | A Double-blind Study of Paclitaxel in Combination With Reparixin or Placebo for Metastatic Triple-Negative Breast Cancer | Completed | non placebo group SD 15/57, CR 1, PR 15/57 | Metastatic Breast Cancer | Drug: paclitaxel|Drug: Reparixin|Drug: placebo | Phase 2 | 194 | |
| AZD5069 | NCT02499328 | Study to Assess MEDI4736 With Either AZD9150 or AZD5069 in Advanced Solid Tumors & Relapsed Metastatic Squamous Cell Carcinoma of Head & Neck | Active, not recruiting | SAE 0 ~ 64.29% in dose escalation | Advanced Solid Tumors & Metastatic Squamous Cell Carcinoma of the Head and Neck | Drug: AZD9150|Drug: MEDI4736|Drug: AZD5069|Drug: tremelimumab (treme) | Phase 1|Phase 2 | 340 |
| NCT02583477 | Phase Ib/II Study of MEDI4736 Evaluated in Different Combinations in Metastatic Pancreatic Ductal Carcinoma | Completed | Dose-Limiting Toxicities (DLT) up to 33.3%, SAE up to 80.00% in cohort 2, study was terminated by sponsor | Metastatic Pancreatic Ductal Adenocarcinoma | Drug: MEDI4736 in combination with nab-paclitaxel and gemcitabine|Drug: MEDI4736 in combination with AZD5069 | Phase 1|Phase 2 | 23 | |
| SX-682 | NCT05604560 | A Neoadjuvant Study of Tislelizumab and SX-682 for Resectable Pancreas Cancer | Not yet recruiting | No Results Available | Pancreatic Cancer | Drug: Tislelizumab|Drug: SX-682 | Phase 2 | 25 |
| NCT04574583 | Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Combination With BinTrafusp Alfa (M7824 or TGF-beta "Trap"/PD-L1) With CV301 TRICOM in Advanced Solid Tumors (STAT) | Active, not recruiting | No Results Available | Metastatic Cancer|Solid Tumors | Drug: SX-682|Drug: M7824|Biological: MVA-BN-CV301|Biological: FPV-CV301 | Phase 1|Phase 2 | 12 | |
| NCT05570825 | SX-682 With Pembrolizumab for the Treatment of Metastatic or Recurrent Stage IIIC or IV Non-Small Cell Lung Cancer | Recruiting | No Results Available | Metastatic Lung Non-Small Cell Carcinoma|Recurrent Lung Non-Small Cell Carcinoma|Stage IIIC Lung Cancer AJCC v8|Stage IV Lung Cancer AJCC v8 | Procedure: Biopsy|Procedure: Biospecimen Collection|Procedure: Computed Tomography|Drug: CXCR1/2 Inhibitor SX-682|Procedure: Magnetic Resonance Imaging|Biological: Pembrolizumab|Procedure: Positron Emission Tomography | Phase 2 | 30 | |
| NCT04599140 | SX-682 and Nivolumab for the Treatment of RAS-Mutated, MSS Unresectable or Metastatic Colorectal Cancer, the STOPTRAFFIC-1 Trial | Recruiting | No Results Available | Metastatic Colon Adenocarcinoma|Metastatic Colorectal Carcinoma|Metastatic Rectal Adenocarcinoma|Stage III Colon Cancer AJCC v8|Stage III Rectal Cancer AJCC v8|Stage IIIA Colon Cancer AJCC v8|Stage IIIA Rectal Cancer AJCC v8|Stage IIIB Colon Cancer AJCC v8|Stage IIIB Rectal Cancer AJCC v8|Stage IIIC Colon Cancer AJCC v8|Stage IIIC Rectal Cancer AJCC v8|Stage IV Colon Cancer AJCC v8|Stage IV Rectal Cancer AJCC v8|Stage IVA Colon Cancer AJCC v8|Stage IVA Rectal Cancer AJCC v8|Stage IVB Colon Cancer AJCC v8|Stage IVB Rectal Cancer AJCC v8|Stage IVC Colon Cancer AJCC v8|Stage IVC Rectal Cancer AJCC v8|Unresectable Colon Adenocarcinoma|Unresectable Rectal Adenocarcinoma | Drug: CXCR1/2 Inhibitor SX-682|Biological: Nivolumab | Phase 1|Phase 2 | 53 | |
| NCT04477343 | A Study to Evaluate the Safety and Tolerability of SX-682 in Combination With Nivolumab as a Maintenance Therapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma | Recruiting | No Results Available | Pancreatic Ductal Adenocarcinoma|Pancreatic Cancer | Drug: SX-682|Drug: Nivolumab Injectable Product | Phase 1 | 20 | |
| NCT03161431 | SX-682 Treatment in Subjects With Metastatic Melanoma Concurrently Treated With Pembrolizumab | Recruiting | No Results Available | Melanoma Stage III|Melanoma Stage IV | Drug: SX-682|Biological: Pembrolizumab | Phase 1 | 77 | |
| NCT04245397 | SX-682 Treatment in Subjects With Myelodysplastic Syndrome Who Had Disease Progression or Are Intolerant to Prior Therapy | Recruiting | No Results Available | Myelodysplastic Syndromes | Drug: SX-682 | Phase 1 | 64 |