Calderasib (MK-1084) Clinical Trials

Size	Price	Qty
1mg	USD 397

Clinical Trials

Multiple clinical trials spanning Phase I, Phase II, and Phase III and sponsored by Merck Sharp & Dohme LLC are evaluating Calderasib (MK-1084) as monotherapy and in combination regimens across advanced solid tumors, non-small cell lung cancer, colon adenocarcinoma, rectal adenocarcinoma, and other malignant neoplasms. Active and recruiting studies include a clinical trial assessing Calderasib with pembrolizumab for non-small cell lung cancer. Furthermore, several clinical trials have completed evaluations of pharmacokinetic parameters, drug interactions, and tolerability in healthy participants as well as individuals with hepatic or renal impairment.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07431827	RECRUITING	Non-small Cell Lung Cancer	Merck Sharp & Dohme LLC	2026-03-18	PHASE3
NCT07554339	RECRUITING	Non-small Cell Lung Cancer	Merck Sharp & Dohme LLC	2026-06-18	PHASE3
NCT07209111	RECRUITING	Neoplasm Malignant	Merck Sharp & Dohme LLC	2025-12-04	PHASE2
NCT05067283	RECRUITING	Advanced Solid Tumors	Merck Sharp & Dohme LLC	2021-12-17	PHASE1
NCT07190248	RECRUITING	Non-small Cell Lung Cancer	Merck Sharp & Dohme LLC	2025-10-08	PHASE3
NCT07252739	RECRUITING	Malignant Neoplasm	Merck Sharp & Dohme LLC	2025-12-19	PHASE2
NCT07286149	RECRUITING	Lung Neoplasm Malignant	Merck Sharp & Dohme LLC	2026-04-30	PHASE1; PHASE2
NCT06997497	RECRUITING	Colon Adenocarcinoma; Rectal Adenocarcinoma	Merck Sharp & Dohme LLC	2025-07-16	PHASE3
NCT06345729	RECRUITING	Non-small Cell Lung Cancer	Merck Sharp & Dohme LLC	2024-05-24	PHASE3
NCT05853367	ACTIVE_NOT_RECRUITING	Metastatic Solid Tumors; Advanced Solid Tumors	Merck Sharp & Dohme LLC	2023-07-06	PHASE1
NCT07219550	COMPLETED	Healthy; Hepatic Impairment	Merck Sharp & Dohme LLC	2025-11-05	PHASE1
NCT06814119	COMPLETED	Healthy; Renal Impairment	Merck Sharp & Dohme LLC	2025-04-07	PHASE1
NCT07222098	COMPLETED	Healthy	Merck Sharp & Dohme LLC	2025-11-19	PHASE1
NCT06942741	COMPLETED	Healthy	Merck Sharp & Dohme LLC	2025-05-13	PHASE1
NCT06575933	COMPLETED	Non-small Cell Lung Cancer	Merck Sharp & Dohme LLC	2024-09-03	PHASE1
NCT06687759	COMPLETED	Healthy	Merck Sharp & Dohme LLC	2024-06-26	PHASE1
NCT06719557	COMPLETED	Healthy	Merck Sharp & Dohme LLC	2024-05-20	PHASE1
NCT06619314	COMPLETED	Healthy	Merck Sharp & Dohme LLC	2023-09-20	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-28)

Check the Calderasib (MK-1084) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Calderasib (MK-1084) selectively binds to the GDP-bound inactive conformation of the mutant KRAS G12C protein, thereby blocking downstream RAS and MAPK signaling cascades essential for cellular proliferation. This targeted pathway suppression impairs malignant cell survival, providing therapeutic activity against KRAS G12C-driven malignancies such as non-small cell lung cancer and advanced 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>).