Multiple Phase 1, Phase 1/2, and Phase 1b clinical trials evaluate MRX-2843 alone or with osimertinib across hematologic malignancies—such as relapsed or refractory acute myeloid, lymphoblastic, and mixed phenotype leukemias—and advanced solid neoplasms including EGFR-mutated non-small cell lung carcinoma. Sponsored by academic institutions like Emory University and commercial entities including Meryx Inc. and Betta Pharmaceuticals Co., Ltd., these studies assess safety, tolerability, pharmacokinetics, and preliminary efficacy. The trials display diverse recruitment statuses, including recruiting, active not recruiting, completed, and unknown.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04762199 | RECRUITING | Advanced Lung Non-Small Cell Carcinoma; Metastatic Lung Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8 |
Emory University |
2021-02-24 | PHASE1 |
| NCT04872478 | RECRUITING | Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Mixed Phenotype Acute Leukemia |
Meryx, Inc. |
2022-04-01 | PHASE1 |
| NCT03510104 | COMPLETED | Advanced Cancer; Metastatic Cancer; Neoplasms; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes |
Meryx, Inc. |
2018-05-22 | PHASE1 |
| NCT04946890 | UNKNOWN | Acute Myeloid Leukemia Leukemia |
Betta Pharmaceuticals Co., Ltd. |
2021-07-01 | PHASE1; PHASE2 |
| NCT04872478 | Recruiting | Acute Myeloid Leukemia|Acute Lymphoblastic Leukemia|Mixed Phenotype Acute Leukemia |
Meryx Inc. |
2022-04-01 | Phase 1 |
| NCT03510104 | Active not recruiting | Advanced Cancer|Metastatic Cancer|Neoplasms|Neoplasm Metastasis|Neoplastic Processes|Pathologic Processes |
Meryx Inc. |
2018-05-22 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2026-03-31)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).