Table 2 Lactylation target drugs in clinical trials.
From: Lactylation in cancer: metabolic mechanism and therapeutic strategies
Drug/Target | Clinicaltrials.gov identifier | Cancer | Type of Trial | Population (N, age) | Intervention | Objective | Primary outcome/endpoint | Status |
|---|---|---|---|---|---|---|---|---|
AZD3965/MCT1 | NCT01791595 | Advanced solid tumors or lymphomas | Phase 1 | 53, age ≥ 18 | Capsule taken daily | Find out the maximum dose that can be given safely to patients | MTD of AZD3965 | Completed (2013-04-23~2020-11-17) |
RRx-001/G6PD | NCT01359982 | Advanced solid tumors or lymphomas | Phase 1 | 26, age ≥ 18 | Intravenous infusions | Evaluate the safety and pharmacokinetic profile of RRx-001 | Number, frequency, and type of adverse events | Completed (2011-09~2015-02) |
NCT02096341 | Advanced Solid Tumors or lymphoma | Phase 1 | 2, age ≥ 18 | Subcutaneous injections | Investigate the dosage of RRx-001 by the subcutaneous route | Number of Participants with Serious and Non-Serious Adverse Events | Terminated (2014-04~2016-01) | |
NCT02096354 | Advanced or metastatic colorectal cancer | Phase 2 | 62, age ≥ 18 | Intravenous infusions | Compare the safety and activity between RRx-001 against regorafenib followed by irinotecan-based therapies | Overall Survival(OS) | Completed (2014-05-~2018-04-13) | |
NCT02215512 | Participants with brain metastases | Phase 1 | 29, age ≥ 18 | Intravenous infusions | test the safety and activity of whole brain radiation therapy with RRx-001 | Number, frequency, and type of adverse events | Completed (2015-02-06-~2016-11-28 | |
NCT02489903 | Platinum Refractory/Resistant Small Cell Carcinoma, EGFR TKI Resistant EGFR + T790M Negative Non-Small Cell Lung Cancer, High-Grade Neuroendocrine Tumors and Resistant/Refractory Ovarian Cancer | Phase 2 | 139, age ≥ 18 | Intravenous infusions | Explore the potential of RRx-001 to sensitize patients who previously received and now have failed a platinum-based doublet regimen | OS | Completed (2015-06-~2021-12-06) | |
NCT02518958 | Advanced, malignant, solid tumor(s) or lymphoma | Phase 1 | 12, age ≥ 18 | Intravenous infusions | Determine the feasibility of co-administration of RRx-001 and nivolumab | Number, frequency, and type of adverse events | Completed (2015-07-21~2016-05-17) | |
NCT02452970 | Biliary tract adenocarcinoma/cholangiocarcinoma | Phase 2 | 4, age ≥ 18 | Intravenous infusions | See if RRx-001 can resensitize the tumor(s) | Overall Objective Response (RECIST) | Terminated (2015-07-16~2016-05-10) | |
NCT02801097 | Advanced, malignant, solid tumor(s) | Phase 1 | 28, age ≥ 18 | Intravenous infusion | Evaluate the safety, pharmacodynamics, and clinical activity of RRx-001 administered in combination with irinotecan | Number, frequency, and type of adverse events | Terminated (2016-08-30~2018-11-22) | |
NCT02871843 | High-grade glioma | Phase 1 | 19, age ≥ 18 | Intravenous infusion | Tests The safety, tolerability, and activity of RRx-001, with standard radiation and temozolomide followed by temozolomide + RRx-001 in newly diagnosed GBM. | Number, frequency, and type of adverse events | Completed (2017-02-14~2019-10-11) | |
NCT03515538 | SCC of the oral cavity and oropharynx | Phase 2 | 48, age≥18 | Intravenous infusion | Determine if RRx-001 reduces the duration or length of severe oral mucositis in patients with head and neck cancers | Duration of Severe Oral Mucositis (SOM) | Completed (2018-07-12~2019-10-22) | |
NCT04525014 | Recurrent or progressive malignant (World Health Organization (WHO) grade 3 or 4 tumors) primary brain or spinal cord tumors and solid tumors (excluding lymphomas) | Phase 1 | 2, age≥18 | Intravenous infusion | Tests the experimental drug RRx-001 in combination with irinotecan and temozolomide in patients with cancer. | Recommended phase 2 dose | Terminated (2023-01-26~2024-07-29) | |
NCT05566041 | Small cell cancer (SCC) | Phase 3 | 292, age ≥ 18 | Intravenous infusion | find out whether RRx-001 + platinum chemotherapy is more effective than platinum chemotherapy alone in 3rd line or beyond small cell cancer | Progression Free Survival (PFS) and OS | Recruiting (2022-08-01~2025-12-31) | |
NCT05966194 | SCC of the oral cavity or oropharynx | Phase 2 | 216, age ≥ 18 | Intravenous infusion | Determine if RRx-001 reduces the incidence of severe oral mucositis in patients with head and neck cancers | Incidence of SOM through Intensity-modulated radiation therapy (IMRT) | Recruiting (2024-04-02~2025-07-01) |
