Numerous clinical trials across Phase 1 through Phase 3 are evaluating HRS-4642 for KRAS G12D-mutated advanced solid tumors, with a primary focus on pancreatic ductal adenocarcinoma, metastatic pancreatic carcinoma, and biliary tract cancer. Sponsored by pharmaceutical developers and academic medical centers, these active, recruiting, and not yet recruiting protocols assess both monotherapy and combination regimens.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07232875 | RECRUITING | KRAS G12D-Mutant Advanced or Metastatic Pancreatic Cancer in the First-line Setting |
Jiangsu HengRui Medicine Co., Ltd. |
2025-11-21 | PHASE3 |
| NCT07503639 | NOT_YET_RECRUITING | Locally Advanced Colorectal Cancer |
Fudan University |
2026-04 | PHASE2 |
| NCT07296341 | RECRUITING | Locally Advanced or Metastatic Pancreatic Cancer With |
Shanghai Hengrui Pharmaceutical Co., Ltd. |
2026-01-08 | PHASE1; PHASE2 |
| NCT07691593 | NOT_YET_RECRUITING | Pancreatic Cancer |
Changhai Hospital |
2026-06 | PHASE2 |
| NCT07438106 | RECRUITING | Locally Advanced Pancreatic Cancer With KRAS G12D Mutation |
The First Affiliated Hospital with Nanjing Medical University |
2026-01-28 | PHASE2 |
| NCT06427239 | RECRUITING | Pancreatic Cancer |
Fudan University |
2024-06-17 | PHASE1; PHASE2 |
| NCT07131514 | RECRUITING | Pancreatic Cancer |
Ruijin Hospital |
2025-08-25 | PHASE2 |
| NCT06587061 | RECRUITING | Pancreatic Cancer |
Ruijin Hospital |
2024-12-03 | PHASE2 |
| NCT07240766 | RECRUITING | Borderline Resectable Pancreatic Adenocarcinoma |
Zhejiang University |
2026-02-15 | PHASE2 |
| NCT06938282 | RECRUITING | Pancreatic Cancer |
Shanghai Zhongshan Hospital |
2025-06-23 | PHASE2 |
| NCT06547736 | RECRUITING | Pancreatic Cancer |
Fudan University |
2024-10-14 | PHASE2 |
| NCT06520488 | RECRUITING | Advanced Solid Tumors |
Jiangsu HengRui Medicine Co., Ltd. |
2024-08-09 | PHASE1; PHASE2 |
| NCT06770452 | RECRUITING | Metastatic Pancreatic Carcinoma |
Zhejiang University |
2025-03-25 | PHASE2 |
| NCT06620848 | RECRUITING | Biliary Tract Cancer |
Shanghai Zhongshan Hospital |
2024-11-21 | PHASE2 |
| NCT06773130 | ACTIVE_NOT_RECRUITING | Pancreatic Ductal Adenocarcinoma (PDAC) |
West China Hospital |
2025-02-10 | PHASE1; PHASE2 |
| NCT06955390 | NOT_YET_RECRUITING | Solid Tumors |
Henan Cancer Hospital |
2025-05-01 | PHASE1; PHASE2 |
| NCT06385678 | ACTIVE_NOT_RECRUITING | Advanced KRAS G12D Mutant Solid Tumors |
Jiangsu HengRui Medicine Co., Ltd. |
2024-07-05 | PHASE1; PHASE2 |
| NCT05533463 | ACTIVE_NOT_RECRUITING | Advanced KRAS G12D Mutant Solid Tumors |
Jiangsu HengRui Medicine Co., Ltd. |
2022-09-21 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-07-15)
Check the
HRS-4642
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
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>).
Note: Technical data last updated: Sep 1, 2026.