Clinical Trials
Numerous Phase 1, Phase 2, and Phase 3 clinical trials evaluate SHR2554 across hematologic malignancies and solid tumors, including peripheral T-cell, extranodal NK/T-cell, and follicular lymphomas, as well as advanced breast, non-small cell lung, and advanced gastric cancers. Sponsored by pharmaceutical entities such as Jiangsu HengRui Medicine Co., Ltd. alongside academic medical centers, these studies span completed, recruiting, and not yet recruiting statuses. Investigations range from pharmacokinetic food-effect evaluations in healthy subjects to therapeutic efficacy assessments in oncology indications.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07562568 | NOT_YET_RECRUITING | Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; MDS; Transplantation, Stem Cell; Conditioning Therapy; SHR2554; Azacytidine |
The First Affiliated Hospital of Soochow University |
2026-06 | PHASE2 |
| NCT07615283 | NOT_YET_RECRUITING | Relapsed or Refractory Peripheral T Cell Lymphoma; NKTCL |
Sun Yat-sen University |
2026-05-29 | PHASE1; PHASE2 |
| NCT07575412 | NOT_YET_RECRUITING | Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; MDS; Transplantation, Stem Cell; Conditioning Therapy; SHR2554; Azacytidine |
The First Affiliated Hospital of Soochow University |
2026-06 | PHASE2 |
| NCT07347288 | NOT_YET_RECRUITING | PTCL |
The First Affiliated Hospital with Nanjing Medical University |
2026-02 | PHASE2 |
| NCT07230106 | RECRUITING | Prostate Cancer |
Jiangsu HengRui Medicine Co., Ltd. |
2025-12-08 | PHASE2 |
| NCT07175220 | RECRUITING | Locally Advanced or Metastatic Non-small Cell Lung Cancer |
Jiangsu HengRui Medicine Co., Ltd. |
2025-10-09 | PHASE2 |
| NCT07725705 | NOT_YET_RECRUITING | PTCL; First Line Treatment |
Institute of Hematology & Blood Diseases Hospital, China |
2026-08-01 | PHASE1; PHASE2 |
| NCT07311408 | RECRUITING | Gastric Cancer (GC); Gastroesophageal Junction Adenocarcinoma |
Jingdong Zhang |
2026-01-01 | PHASE2 |
| NCT07502768 | RECRUITING | Extranodal NK/T-cell Lymphoma; NK/T-cell Lymphoma; Relapsed or Refractory NK/T-Cell Lymphoma |
Rong Tao |
2026-04-30 | PHASE1; PHASE2 |
| NCT07102901 | RECRUITING | Advanced Gastric Cancer; Metastatic Gastric Cancer; Gastroesophageal Junction Adenocarcinoma |
Jiangsu HengRui Medicine Co., Ltd. |
2025-09-05 | PHASE2 |
| NCT07125950 | NOT_YET_RECRUITING | Advanced Breast Cancer |
Henan Cancer Hospital |
2025-09-30 | PHASE2 |
| NCT07294664 | RECRUITING | Advanced Gastric Cancer; SHR1701 |
The First Affiliated Hospital of Zhengzhou University |
2025-06-15 | PHASE2 |
| NCT06368167 | NOT_YET_RECRUITING | Follicular Lymphoma |
Jiangsu HengRui Medicine Co., Ltd. |
2024-04 | PHASE2 |
| NCT06519526 | RECRUITING | Relapsed/Refractory Peripheral T Cell Lymphoma |
Fudan University |
2024-08-12 | PHASE2 |
| NCT06568094 | RECRUITING | Prostate Cancer |
Jiangsu HengRui Medicine Co., Ltd. |
2024-09-25 | PHASE1; PHASE2 |
| NCT06122389 | RECRUITING | Relapsed/Refractory PTCLT With at Least One Line of Prior Systemic Therapy |
Jiangsu HengRui Medicine Co., Ltd. |
2024-02-05 | PHASE3 |
| NCT03603951 | ACTIVE_NOT_RECRUITING | Relapsed or Refractory Mature Lymphoid Neoplasms |
Jiangsu HengRui Medicine Co., Ltd. |
2018-08-14 | PHASE1 |
| NCT06173999 | UNKNOWN | Peripheral T-cell Lymphoma |
Jiangsu HengRui Medicine Co., Ltd. |
2023-12-22 | PHASE1; PHASE2 |
| NCT06679673 | NOT_YET_RECRUITING | Colorectal Cancer Metastatic |
Fudan University |
2024-12 | PHASE2 |
| NCT06712173 | NOT_YET_RECRUITING | Peripheral T Cell Lymphoma |
Institute of Hematology & Blood Diseases Hospital, China |
2024-12-01 | PHASE1 |
| NCT05896046 | UNKNOWN | Relapsed or Refractory Hodgkin Lymphoma |
Chinese PLA General Hospital |
2023-06-14 | PHASE1; PHASE2 |
| NCT04407741 | UNKNOWN | Solid Tumor; Lymphoma |
Chinese PLA General Hospital |
2020-09-01 | PHASE1; PHASE2 |
| NCT05559008 | UNKNOWN | Peripheral T Cell Lymphoma |
Ruijin Hospital |
2022-09-30 | PHASE1; PHASE2 |
| NCT06093945 | COMPLETED | Malignant Tumor |
Jiangsu HengRui Medicine Co., Ltd. |
2023-11-06 | PHASE1 |
| NCT06010680 | COMPLETED | Lymphoma |
Jiangsu HengRui Medicine Co., Ltd. |
2023-10-07 | PHASE1 |
| NCT04355858 | UNKNOWN | Breast Cancer; Metastatic Cancer |
Fudan University |
2020-05-01 | PHASE2 |
| NCT05661591 | COMPLETED | Malignant Tumor |
Jiangsu HengRui Medicine Co., Ltd. |
2023-02-28 | PHASE1 |
| NCT05592262 | COMPLETED | Malignant Tumor |
Jiangsu HengRui Medicine Co., Ltd. |
2022-11-15 | PHASE1 |
| NCT05049083 | UNKNOWN | Lymphoma |
Jiangsu HengRui Medicine Co., Ltd. |
2021-12-17 | PHASE1 |
| NCT04627129 | COMPLETED | Healthy Adult Subjects |
Jiangsu HengRui Medicine Co., Ltd. |
2020-06-01 | PHASE1 |
| NCT04577885 | COMPLETED | Healthy |
Jiangsu HengRui Medicine Co., Ltd. |
2020-05-28 | PHASE1 |
| NCT03741712 | TERMINATED | Prostate Cancer; Castration-resistant Prostate Cancer |
Jiangsu HengRui Medicine Co., Ltd. |
2018-11-20 | PHASE1; PHASE2 |
| NCT04335266 | COMPLETED | Healthy Adult Subjects |
Jiangsu HengRui Medicine Co., Ltd. |
2019-08-06 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-05-01)
Check the
SHR2554
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Compliance for Clinical Use
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>).
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Note: Technical data last updated: Sep 1, 2026.