Clinical Trials

Numerous clinical trials spanning early to late phases evaluate garsorasib (D-1553) as monotherapy or combination regimens for KRAS G12C-mutated non-small cell lung cancer, colorectal cancer, advanced solid tumors, and pharmacokinetic profiling in healthy subjects. Sponsored by commercial entities, such as InventisBio Co. Ltd and InxMed (Shanghai) Co. Ltd., alongside academic institutions like Sun Yat-sen University and Guangdong Provincial People's Hospital, these studies encompass recruitment statuses ranging from not yet recruiting and active to completed.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07294261 NOT_YET_RECRUITING
Local Advanced or Metastatic NSCLC
Sun Yat-sen University
 2025-12-23 PHASE2
NCT07174908 RECRUITING
Non-Small Cell Lung Cancer
InxMed (Shanghai) Co., Ltd.
 2025-09-10 PHASE3
NCT07601048 NOT_YET_RECRUITING
KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer Patients Who Have Failed Standard Treatment
Shandong Suncadia Medicine Co., Ltd.
 2026-06 PHASE3
NCT07472478 NOT_YET_RECRUITING
Lung Cancer (NSCLC); KRAS G12C Lung Cancer
Guangdong Provincial People's Hospital
 2026-03-15 PHASE2
NCT05379946 ACTIVE_NOT_RECRUITING
Solid Tumor
InventisBio Co., Ltd
 2022-10-12 PHASE1; PHASE2
NCT06166836 ACTIVE_NOT_RECRUITING
Solid Tumor
InxMed (Shanghai) Co., Ltd.
 2022-10-12 PHASE1; PHASE2
NCT06435455 NOT_YET_RECRUITING
Locally Advanced or Metastatic Solid Tumors Harboring KRAS G12C Mutation
Suzhou Genhouse Bio Co., Ltd.
 2024-07-01 PHASE1; PHASE2
NCT07318649 NOT_YET_RECRUITING
Locally Advanced or Metastatic Solid Tumors
Suzhou Genhouse Bio Co., Ltd.
 2025-12-30 PHASE2
NCT06300177 RECRUITING
Non Small Cell Lung Cancer
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
 2024-03-28 PHASE3
NCT05492045 TERMINATED
NSCLC
InventisBio Co., Ltd
 2022-09-13 PHASE1; PHASE2
NCT04585035 ACTIVE_NOT_RECRUITING
Solid Tumor, Adult; NSCLC; CRC
InventisBio Co., Ltd
 2020-10-02 PHASE1; PHASE2
NCT06105255 COMPLETED
Healthy Male
InventisBio Co., Ltd
 2023-05-24 PHASE1
NCT06233916 COMPLETED
Mass Balance Study
InventisBio Co., Ltd
 2023-12-08 PHASE1
NCT06233916 Completed
Mass Balance Study
InventisBio Co. Ltd
 2023-12-08 Phase 1
NCT05383898 COMPLETED
NSCLC
InventisBio Co., Ltd
 2021-03-16 PHASE1; PHASE2
NCT06105255 Active not recruiting
Healthy Male
InventisBio Co. Ltd
 2023-05-24 Phase 1
NCT06166836 Recruiting
Solid Tumor
InxMed (Shanghai) Co. Ltd.|InventisBio Co. Ltd
 2022-10-12 Phase 1|Phase 2
NCT05492045 Recruiting
NSCLC
InventisBio Co. Ltd
 2022-09-13 Phase 1|Phase 2
NCT05383898 Active not recruiting
NSCLC
InventisBio Co. Ltd
 2021-03-16 Phase 1|Phase 2

(data from https://clinicaltrials.gov, updated on 2025-12-19)

Check the garsorasib (D-1553) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Garsorasib (D-1553) selectively binds to and locks the mutated KRAS G12C protein in an inactive GDP-bound state, thereby inhibiting downstream RAF/MEK/ERK signaling pathways to suppress cancer cell proliferation and survival. This targeted inhibition effectively impairs tumor cell growth in KRAS G12C-mutated malignancies, supporting its clinical evaluation for patients with advanced non-small cell lung cancer and solid tumors.

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.