Zoldonrasib (RMC-9805) Clinical Trials

Size	Price	Qty
1mg	USD 177
5mg	USD 570

Clinical Trials

Several clinical trials are currently recruiting participants to evaluate Zoldonrasib (RMC-9805) across Phase I, Phase II, and Phase III stages in patients with KRAS G12D-mutated and advanced solid tumors, including pancreatic ductal adenocarcinoma, non-small cell lung cancer, colorectal cancer, and gastrointestinal malignancies. Predominantly sponsored by Revolution Medicines, Inc., with participation from Tango Therapeutics, Inc., these studies range from Phase I/II platform trials assessing safety, tolerability, and combination therapeutic strategies to confirmatory Phase III investigations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07777822	RECRUITING	NSCLC; Non-small Cell Lung Cancer; Non-Small Cell Lung Cancer NSCLC; Non-Squamous Non Small Cell Lung Cancer; Lung Cancer (NSCLC); Metastatic NSCLC - Non-Small Cell Lung Cancer; Metastatic Non-Squamous Non-Small Cell Lung Cancer	Revolution Medicines, Inc.	2026-08-14	PHASE3
NCT07621718	RECRUITING	Pancreatic Cancer; Pancreatic Cancer Metastatic; PDAC; PDAC - Pancreatic Ductal Adenocarcinoma; Pancreatic Ductal Adenocarcinoma (PDAC); Pancreatic Adenocarcinoma Metastatic; Pancreatic Adenocarcinoma; Pancreatic Adenosquamous Carcinoma	Revolution Medicines, Inc.	2026-05-22	PHASE3
NCT06162221	RECRUITING	Non-Small Cell Lung Cancer, NSCLC; KRAS, NRAS, HRAS-mutated NSCLC; KRAS G12C-mutated Solid Tumors, Lung Cancer; Lung Cancer Stage IV, Advanced Solid Tumor, Cancer; RAS G12D-mutated NSCLC	Revolution Medicines, Inc.	2024-01-18	PHASE1; PHASE2
NCT06922591	RECRUITING	PDAC; PDAC - Pancreatic Ductal Adenocarcinoma; NSCLC; RAS Mutation; MTAP Deletion; Lung Cancer; Pancreatic Cancer Metastatic; Thoracic Cancer	Tango Therapeutics, Inc.	2025-05-31	PHASE1; PHASE2
NCT06445062	RECRUITING	Colorectal Cancer; CRC; Pancreatic Ductal Adenocarcinoma; PDAC; Gastrointestinal Cancer; Metastatic Pancreatic Ductal Adenocarcinoma	Revolution Medicines, Inc.	2024-05-24	PHASE1; PHASE2
NCT06040541	RECRUITING	Non-small Cell Lung Cancer (NSCLC); Colorectal Cancer (CRC); Pancreatic Ductal Adenocarcinoma (PDAC); Advanced Solid Tumors	Revolution Medicines, Inc.	2023-09-07	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-20)

Check the Zoldonrasib (RMC-9805) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Zoldonrasib (RMC-9805) is an orally active inhibitor that selectively binds the mutant KRAS G12D protein, thereby disrupting oncogenic RAS signaling pathways and inducing apoptosis in cancer cells harboring this mutation. By suppressing downstream proliferative and pro-survival signals, this targeted inhibition halts tumor expansion, demonstrating direct therapeutic relevance for treating KRAS G12D-mutated malignancies such as pancreatic ductal adenocarcinoma, non-small cell lung cancer, and colorectal cancer evaluated in clinical trials.

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>).